CLASS I ONGOING Device recall · Reported 14 May 2025 · FDA Enforcement Report

Intraocular Lens recalled by Bausch & Lomb Surgical

Bausch & Lomb Surgical is recalling Intraocular Lens, distributed nationwide in the US. The recall was initiated on 27 Mar 2025 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesDescription/Lots/UDI-DI: enVista Envy IOL (ENU)/3Q24764, 3Q24935, 3Q25113, 3Q25833, 3Q26256, 3Q26257, 3Q26538, 3Q26601, 3Q26603, 3Q26604, 3Q26679, 3Q26680, 3Q27353, 3Q27447, 3Q27457, 3Q27905, 3Q27907, 3Q28001, 3Q28002, 3Q28124, 3Q28125, 3Q28801, 3Q28901, 3Q28903, 3Q28904, 3Q28905, 3Q28906, 3Q29020, 3Q29021, 3Q29205, 3Q29266, 3Q29301, 3Q29302, 3Q29304, 3Q29305, 3Q29306, 3Q29401, 3Q29403, 3Q29405, 3Q29406, 3Q29545, 3Q29547, 3Q29548, 3Q29636, 3Q29637, 3Q29835, 3Q29837, 3Q30210, 3Q30310, 3Q30311, 3Q33702, 3Q33822, 3Q33918, 3Q33921, 3Q33924, 3Q33925, 3Q33928, 3Q34031, 3Q34034, 3Q34205, 3Q35006, 3Q35733, 3Q35735, 3Q35736, 3Q35738, 3Q35813, 3R01610, 3R01611, 3R02532, 3R02534, 3R02536, 3R02537, 3R02540, 3R02542, 3R02551, 3R02553, 3R02608, 3R02749, 3R02750, 3R02846, 3R03533, 3R03534, 3R03536, 3R03804, 3R03805, 3R03806, 3R04414, 3R04533, 3R05051, 3R05411, 3Q24749, 3Q24750, 3Q24751, 3Q24756, 3Q24763, 3Q24765, 3Q24766, 3Q24837, 3Q24842, 3Q24934, 3Q25115, 3Q25116, 3Q25117, 3Q25118, 3Q25119, 3Q25421, 3Q25422, 3Q25423, 3Q25424, 3Q25506, 3Q25834, 3Q25922, 3Q25923, 3Q26525, 3Q26527, 3Q26539, 3Q26602, 3Q26605, 3Q27252, 3Q27321, 3Q27322, 3Q27323, 3Q27324, 3Q27354, 3Q27456, 3Q27458, 3Q27906, 3Q27908, 3Q28003, 3Q28004, 3Q28011, 3Q28012, 3Q28802, 3Q29017, 3Q29018, 3Q29022, 3Q29203, 3Q29204, 3Q29303, 3Q29402, 3Q29404, 3Q29546, 3Q29550, 3Q29635, 3Q30211, 3Q30213, 3Q32503, 3Q33816, 3Q33817, 3Q33818, 3Q33819, 3Q33820, 3Q33821, 3Q33823, 3Q33920, 3Q33922, 3Q33926, 3Q33927, 3Q33929, 3Q34032, 3Q34033, 3Q34201, 3Q34202, 3Q34203, 3Q34204, 3Q34901, 3Q34903, 3Q35028, 3Q35031, 3Q35734, 3Q35812, 3R01612, 3R02136, 3R02535, 3R02539, 3R02541, 3R02543, 3R02601, 3R02602, 3R02603, 3R02607, 3R02710, 3R02711, 3R02845, 3R02848, 3R03411, 3R03502, 3R03643, 3R04411, 3R04412, 3R04531, 3R05048, 3R05049, 3R05052, 3R05627/ 10757770636478, 10757770637017, 10757770637031, 10757770637055, 10757770637079, 10757770637543, 10757770637093, 10757770637109, 10757770637536, 10757770637116, 10757770637123, 10757770637130, 10757770637147, 10757770637154, 10757770637161, 10757770637178, 10757770637185, 10757770637192, 10757770637208, 10757770637215, 10757770637222, 10757770637239, 10757770637246, 10757770637253, 10757770636485, 10757770637550, 10757770637277, 10757770637284, 10757770637291, 10757770637307, 10757770637314, 10757770637321, 10757770637338, 10757770637345, 10757770637352, 10757770637369, 10757770637376, 10757770637383, 10757770637390, 10757770637406, 10757770637413, 10757770637420, 10757770637437, 10757770637444, 10757770637451, 10757770637468, 10757770637475, 10757770637482, 10757770637499, 10757770637505, 10757770637512, 10757770637529, 10757770636492; enVista Envy Toric IOL (ETNU)/3Q25926, 3Q25930, 3Q26240, 3Q26426, 3Q26431, 3Q26435, 3Q26436, 3Q26440, 3Q26441, 3Q26621, 3Q26726, 3Q26727, 3Q26731, 3Q26819, 3Q26820, 3Q26910, 3Q26928, 3Q27216, 3Q27217, 3Q27219, 3Q27221, 3Q27223, 3Q27249, 3Q27250, 3Q27251, 3Q27264, 3Q27327, 3Q27330, 3Q27505, 3Q27506, 3Q27518, 3Q27742, 3Q27912, 3Q28007, 3Q28008, 3Q28009, 3Q28010, 3Q28013, 3Q28134, 3Q28136, 3Q28721, 3Q28809, 3Q28818, 3Q28908, 3Q28909, 3Q28910, 3Q29208, 3Q29210, 3Q29212, 3Q29409, 3Q29517, 3Q29642, 3Q29922, 3Q29959, 3Q29961, 3Q30005, 3Q30136, 3Q30137, 3Q30138, 3Q30139, 3Q30208, 3Q30309, 3Q30453, 3Q30454, 3Q30517, 3Q30646, 3Q30647, 3Q30725, 3Q30741, 3Q30744, 3Q30803, 3Q31102, 3Q31107, 3Q31108, 3Q31509, 3Q31540, 3Q31541, 3Q31543, 3Q31865, 3Q31866, 3Q31929, 3Q32003, 3Q32004, 3Q32005, 3Q32009, 3Q32010, 3Q32206, 3Q32209, 3Q32211, 3Q32330, 3Q32331, 3Q32439, 3Q32443, 3Q32525, 3Q32529, 3Q32530, 3Q32606, 3Q32735, 3Q32737, 3Q32743, 3Q32842, 3Q32844, 3Q32846, 3Q32851, 3Q32931, 3Q32932, 3Q33014, 3Q33015, 3Q33128, 3Q33203, 3Q33505, 3Q33508, 3Q33545, 3Q33604, 3Q33613, 3Q33721, 3Q33902, 3Q34121, 3Q34256, 3Q34258, 3Q34315, 3Q35117, 3Q35335, 3Q35430, 3Q35431, 3Q35432, 3Q35433, 3Q35532, 3Q35557, 3Q35624, 3Q35625, 3Q35626, 3Q35628, 3Q35631, 3Q35704, 3Q35741, 3Q35758, 3Q35942, 3R00250, 3R01019, 3R01604, 3R01905, 3R02801, 3R03722, 3R03807, 3R04116, 3Q24946, 3Q25501, 3Q25605, 3Q25606, 3Q25703, 3Q25704, 3Q25722, 3Q25723, 3Q25725, 3Q25740, 3Q25741, 3Q25835, 3Q25836, 3Q25838, 3Q25839, 3Q25924, 3Q25925, 3Q25928, 3Q25931, 3Q25932, 3Q25933, 3Q26003, 3Q26004, 3Q26011, 3Q26012, 3Q26013, 3Q26059, 3Q26060, 3Q26061, 3Q26062, 3Q26063, 3Q26075, 3Q26076, 3Q26077, 3Q26078, 3Q26079, 3Q26080, 3Q26101, 3Q26102, 3Q26211, 3Q26212, 3Q26213, 3Q26214, 3Q26215, 3Q26216, 3Q26217, 3Q26230, 3Q26231, 3Q26232, 3Q26233, 3Q26234, 3Q26235, 3Q26236, 3Q26237, 3Q26238, 3Q26239, 3Q26241, 3Q26259, 3Q26260, 3Q26320, 3Q26321, 3Q26322, 3Q26323, 3Q26324, 3Q26325, 3Q26326, 3Q26327, 3Q26427, 3Q26428, 3Q26430, 3Q26432, 3Q26433, 3Q26434, 3Q26437, 3Q26439, 3Q26442, 3Q26443, 3Q26523, 3Q26524, 3Q26620, 3Q26623, 3Q26624, 3Q26625, 3Q26626, 3Q26721, 3Q26722, 3Q26723, 3Q26724, 3Q26725, 3Q26728, 3Q26729, 3Q26730, 3Q26732, 3Q26821, 3Q26822, 3Q26823, 3Q26824, 3Q26901, 3Q26902, 3Q26903, 3Q26904, 3Q26905, 3Q26908, 3Q26909, 3Q26930, 3Q27218, 3Q27220, 3Q27222, 3Q27224, 3Q27225, 3Q27248, 3Q27256, 3Q27265, 3Q27325, 3Q27326, 3Q27328, 3Q27329, 3Q27331, 3Q27332, 3Q27333, 3Q27334, 3Q27335, 3Q27350, 3Q27351, 3Q27352, 3Q27449, 3Q27501, 3Q27502, 3Q27503, 3Q27504, 3Q27516, 3Q27517, 3Q27519, 3Q27624, 3Q27625, 3Q27626, 3Q27627, 3Q27628, 3Q27629, 3Q27743, 3Q27744, 3Q27745, 3Q27909, 3Q27910, 3Q27911, 3Q27913, 3Q27914, 3Q28005, 3Q28006, 3Q28014, 3Q28127, 3Q28129, 3Q28130, 3Q28131, 3Q28132, 3Q28133, 3Q28135, 3Q28228, 3Q28719, 3Q28806, 3Q28807, 3Q28808, 3Q28810, 3Q28907, 3Q28911, 3Q29104, 3Q29105, 3Q29106, 3Q29128, 3Q29129, 3Q29130, 3Q29206, 3Q29207, 3Q29209, 3Q29211, 3Q29213, 3Q29214, 3Q29307, 3Q29308, 3Q29309, 3Q29310, 3Q29311, 3Q29312, 3Q29407, 3Q29408, 3Q29410, 3Q29411, 3Q29412, 3Q29451, 3Q29452, 3Q29515, 3Q29516, 3Q29518, 3Q29519, 3Q29520, 3Q29522, 3Q29523, 3Q29643, 3Q29644, 3Q29645, 3Q29705, 3Q29706, 3Q29707, 3Q29708, 3Q29709, 3Q29710, 3Q29711, 3Q29712, 3Q29713, 3Q29801, 3Q29838, 3Q29920, 3Q29921, 3Q29923, 3Q29957, 3Q29958, 3Q29960, 3Q30001, 3Q30002, 3Q30003, 3Q30004, 3Q30140, 3Q30201, 3Q30202, 3Q30203, 3Q30204, 3Q30205, 3Q30206, 3Q30207, 3Q30209, 3Q30301, 3Q30302, 3Q30303, 3Q30305, 3Q30306, 3Q30307, 3Q30308, 3Q30403, 3Q30434, 3Q30435, 3Q30437, 3Q30439, 3Q30440, 3Q30515, 3Q30516, 3Q30520, 3Q30523, 3Q30635, 3Q30636, 3Q30637, 3Q30648, 3Q30649, 3Q30740, 3Q30742, 3Q30743, 3Q30746, 3Q30747, 3Q30748, 3Q30749, 3Q30801, 3Q30812, 3Q30814, 3Q30815, 3Q30816, 3Q30817, 3Q30818, 3Q30902, 3Q30903, 3Q30904, 3Q30926, 3Q30927, 3Q30939, 3Q30940, 3Q30941, 3Q30942, 3Q31006, 3Q31007, 3Q31008, 3Q31042, 3Q31043, 3Q31053, 3Q31054, 3Q31101, 3Q31103, 3Q31104, 3Q31105, 3Q31106, 3Q31109, 3Q31110, 3Q31213, 3Q31214, 3Q31218, 3Q31219, 3Q31237, 3Q31238, 3Q31239, 3Q31450, 3Q31507, 3Q31508, 3Q31539, 3Q31542, 3Q31544, 3Q31601, 3Q31604, 3Q31605, 3Q31606, 3Q31607, 3Q31608, 3Q31609, 3Q31610, 3Q31611, 3Q31715, 3Q31716, 3Q31717, 3Q31718, 3Q31719, 3Q31720, 3Q31721, 3Q31842, 3Q31843, 3Q31844, 3Q31867, 3Q31868, 3Q31928, 3Q31930, 3Q31931, 3Q31932, 3Q31933, 3Q32001, 3Q32002, 3Q32006, 3Q32007, 3Q32008, 3Q32011, 3Q32012, 3Q32037, 3Q32128, 3Q32129, 3Q32130, 3Q32131, 3Q32155, 3Q32156, 3Q32157, 3Q32158, 3Q32159, 3Q32160, 3Q32201, 3Q32202, 3Q32203, 3Q32204, 3Q32205, 3Q32207, 3Q32208, 3Q32210, 3Q32212, 3Q32328, 3Q32329, 3Q32408, 3Q32409, 3Q32410, 3Q32411, 3Q32412, 3Q32440, 3Q32441, 3Q32442, 3Q32444, 3Q32506, 3Q32521, 3Q32522, 3Q32523, 3Q32524, 3Q32526, 3Q32527, 3Q32528, 3Q32607, 3Q32704, 3Q32738, 3Q32739, 3Q32740, 3Q32741, 3Q32742, 3Q32744, 3Q32745, 3Q32843, 3Q32845, 3Q32847, 3Q32848, 3Q32849, 3Q32850, 3Q32929, 3Q32930, 3Q32933, 3Q32934, 3Q32935, 3Q32936, 3Q32937, 3Q33004, 3Q33008, 3Q33009, 3Q33010, 3Q33011, 3Q33012, 3Q33013, 3Q33016, 3Q33017, 3Q33018, 3Q33019, 3Q33101, 3Q33102, 3Q33103, 3Q33129, 3Q33130, 3Q33131, 3Q33132, 3Q33133, 3Q33134, 3Q33204, 3Q33206, 3Q33207, 3Q33208, 3Q33503, 3Q33504, 3Q33506, 3Q33507, 3Q33543, 3Q33544, 3Q33546, 3Q33548, 3Q33605, 3Q33606, 3Q33607, 3Q33611, 3Q33614, 3Q33718, 3Q33719, 3Q33720, 3Q33722, 3Q33723, 3Q33731, 3Q33732, 3Q33824, 3Q33825, 3Q33826, 3Q33827, 3Q33828, 3Q33829, 3Q33901, 3Q34122, 3Q34123, 3Q34124, 3Q34125, 3Q34126, 3Q34127, 3Q34209, 3Q34210, 3Q34211, 3Q34257, 3Q34316, 3Q34317, 3Q34319, 3Q34320, 3Q34321, 3Q34323, 3Q34324, 3Q34325, 3Q34326, 3Q34327, 3Q34328, 3Q34329, 3Q34330, 3Q34331, 3Q34334, 3Q34335, 3Q34336, 3Q34431, 3Q34432, 3Q34436, 3Q34438, 3Q34440, 3Q34516, 3Q34518, 3Q34521, 3Q34522, 3Q34523, 3Q34524, 3Q34527, 3Q34528, 3Q34529, 3Q34530, 3Q34532, 3Q34536, 3Q34537, 3Q34538, 3Q34628, 3Q34633, 3Q34712, 3Q34713, 3Q34715, 3Q34716, 3Q34719, 3Q34720, 3Q34729, 3Q34732, 3Q34745, 3Q34828, 3Q34831, 3Q34832, 3Q34833, 3Q34835, 3Q34836, 3Q34837, 3Q34839, 3Q34840, 3Q34842, 3Q34843, 3Q34845, 3Q34913, 3Q34914, 3Q34916, 3Q34919, 3Q34921, 3Q35022, 3Q35118, 3Q35119, 3Q35120, 3Q35122, 3Q35123, 3Q35126, 3Q35127, 3Q35174, 3Q35213, 3Q35217, 3Q35220, 3Q35223, 3Q35225, 3Q35226, 3Q35336, 3Q35337, 3Q35340, 3Q35341, 3Q35342, 3Q35346, 3Q35348, 3Q35350, 3Q35408, 3Q35429, 3Q35527, 3Q35528, 3Q35529, 3Q35530, 3Q35531, 3Q35534, 3Q35535, 3Q35536, 3Q35559, 3Q35560, 3Q35627, 3Q35629, 3Q35630, 3Q35703, 3Q35739, 3Q35740, 3Q35750, 3Q35842, 3Q35936, 3Q35937, 3Q35938, 3Q35939, 3Q35941, 3R00247, 3R00248, 3R00254, 3R00324, 3R00510, 3R00601, 3R00603, 3R00618, 3R00713, 3R01020, 3R01111, 3R01201, 3R01416, 3R01519, 3R01602, 3R01605, 3R01722, 3R01724, 3R01903, 3R02301, 3R02304, 3R02309, 3R02310, 3R02401, 3R02402, 3R02409, 3R02411, 3R02421, 3R02422, 3R02424, 3R02441, 3R02442, 3R02443, 3R02444, 3R02446, 3R02447, 3R02448, 3R02450, 3R02544, 3R02548, 3R02728, 3R02802, 3R02821, 3R02824, 3R02826, 3R03034, 3R03036, 3R03037, 3R03038, 3R03039, 3R03040, 3R03105, 3R03106, 3R03134, 3R03135, 3R03137, 3R03139, 3R03140, 3R03141, 3R03233, 3R03234, 3R03301, 3R03302, 3R03505, 3R03506, 3R03507, 3R03720, 3R03721, 3R03723, 3R03808, 3R03812, 3R04115, 3R04342, 3R04746, 3R05032, 3R05141/ 10757770640000, 10757770640017, 10757770640024, 10757770640031, 10757770640048, 10757770640055, 10757770640574, 10757770640062, 10757770640079, 10757770640086, 10757770640093, 10757770640109, 10757770640116, 10757770640123, 10757770640130, 10757770640147, 10757770640154, 10757770640161, 10757770640178, 10757770640185, 10757770640192, 10757770640208, 10757770640215, 10757770640222, 10757770640239, 10757770640246, 10757770640253, 10757770640260, 10757770640277, 10757770640284, 10757770640291, 10757770640307, 10757770640314, 10757770640321, 10757770640338, 10757770640345, 10757770640352, 10757770640369, 10757770640376, 10757770640383, 10757770640390, 10757770640406, 10757770640413, 10757770640420, 10757770640437, 10757770640444, 10757770640451, 10757770640468, 10757770640475, 10757770640482, 10757770640499, 10757770640505, 10757770640512, 10757770640529, 10757770640536, 10757770640543, 10757770640550, 10757770640567, 10757770640581, 10757770640598, 10757770640604, 10757770640611, 10757770640628, 10757770640635, 10757770640642, 10757770640659, 10757770640666, 10757770640673, 10757770640680, 10757770640697, 10757770640703, 10757770640710, 10757770640727, 10757770640734, 10757770640741, 10757770640758, 10757770640765, 10757770640772, 10757770640789, 10757770640796, 10757770640802, 10757770640819, 10757770640826, 10757770640833, 10757770640840, 10757770640857, 10757770640864, 10757770640871, 10757770640888, 10757770640895, 10757770640901, 10757770640918, 10757770640925, 10757770640932, 10757770640949, 10757770640956, 10757770640963, 10757770640970, 10757770640987, 10757770640994, 10757770641007, 10757770641014, 10757770641021, 10757770641038, 10757770641045, 10757770641052, 10757770641069, 10757770641076, 10757770641083, 10757770641090, 10757770641106, 10757770641113, 10757770641120, 10757770641137, 10757770641144, 10757770641151, 10757770641168, 10757770641175, 10757770641182, 10757770641199, 10757770641205, 10757770641212, 10757770641229, 10757770641236, 10757770641243, 10757770641250, 10757770641267, 10757770641274, 10757770641281, 10757770641298, 10757770641304, 10757770641311, 10757770641328, 10757770641335, 10757770641342, 10757770641359, 10757770641366, 10757770641373, 10757770641380, 10757770641397, 10757770641403, 10757770641410, 10757770641427, 10757770641434, 10757770641441, 10757770641458, 10757770641465, 10757770641472, 10757770641496, 10757770641502, 10757770641519, 10757770641526, 10757770641533, 10757770641540, 10757770641557, 10757770641564, 10757770641571, 10757770641588, 10757770641595, 10757770641601, 10757770641618, 10757770641625, 10757770641632, 10757770641649, 10757770641656, 10757770641663, 10757770641670, 10757770641687, 10757770641694, 10757770641700, 10757770641717, 10757770636553, 10757770641724, 10757770641731, 10757770641748, 10757770641755, 10757770641762, 10757770641779, 10757770641786, 10757770641793, 10757770641809, 10757770641816, 10757770641823, 10757770641830, 10757770641847, 10757770641854, 10757770641861, 10757770641878, 10757770641885, 10757770641892, 10757770641908, 10757770641915, 10757770641922, 10757770641939, 10757770641946, 10757770641953, 10757770641977, 10757770641984, 10757770641991, 10757770636560, 10757770642004, 10757770642011, 10757770642028, 10757770642035, 10757770642042, 10757770642059, 10757770642066, 10757770642073, 10757770642080, 10757770642097, 10757770642103, 10757770642110, 10757770642134, 10757770642141, 10757770642158, 10757770642165, 10757770642172, 10757770642189, 10757770642196, 10757770642202, 10757770642219, 10757770642226, 10757770642233, 10757770642240, 10757770642257, 10757770642264, 10757770642271, 10757770636577, 10757770642851, 10757770642868, 10757770642875, 10757770642882, 10757770642899, 10757770642905, 10757770642912, 10757770642929, 10757770642936, 10757770642943, 10757770642950, 10757770642967, 10757770642974, 10757770642981, 10757770642998, 10757770643001, 10757770643018, 10757770643025, 10757770643032, 10757770643049, 10757770643056, 10757770643063, 10757770643070, 10757770643087, 10757770643094, 10757770643100, 10757770643117, 10757770643124, 10757770643131, 10757770643148, 10757770643155, 10757770643162, 10757770643179, 10757770643186, 10757770643193, 10757770643209, 10757770643216, 10757770643223, 10757770643230, 10757770643247, 10757770643254, 10757770643261, 10757770643278, 10757770643285, 10757770643292, 10757770643308, 10757770643315, 10757770643322, 10757770643339, 10757770643346, 10757770643353, 10757770643360, 10757770643377, 10757770643384, 10757770643391, 10757770643407, 10757770643414, 10757770643469, 10757770643421, 10757770643438, 10757770643445, 10757770643452, 10757770643476, 10757770643483, 10757770643490, 10757770643506, 10757770643513, 10757770643520, 10757770643537, 10757770643544, 10757770643551, 10757770643568, 10757770643575, 10757770643582, 10757770643599, 10757770643605, 10757770643612, 10757770643629, 10757770643636, 10757770643643, 10757770643650, 10757770643667, 10757770643674, 10757770643681, 10757770643698, 10757770643704, 10757770643711, 10757770643728, 10757770643735, 10757770643742, 10757770643759, 10757770643766, 10757770643773, 10757770643780, 10757770643797, 10757770643803, 10757770643810, 10757770643827, 10757770643834, 10757770643841, 10757770643858, 10757770643865, 10757770643872, 10757770643889, 10757770643896, 10757770643902, 10757770643919, 10757770643926, 10757770643933, 10757770643940, 10757770643957, 10757770643964, 10757770643971, 10757770643988, 10757770643995, 10757770644008, 10757770644015, 10757770644022, 10757770644039, 10757770644046, 10757770644053, 10757770644060, 10757770644077, 10757770644084, 10757770644091, 10757770644107, 10757770644114, 10757770644121, 10757770644138, 10757770644145, 10757770644152, 10757770644169, 10757770644176, 10757770644183, 10757770644190, 10757770644206, 10757770644213, 10757770644220, 10757770644237, 10757770644244, 10757770644251, 10757770644268, 10757770644275, 10757770644282, 10757770644299, 10757770644305, 10757770644312, 10757770644329, 10757770644336, 10757770644343, 10757770644350, 10757770644367, 10757770644374, 10757770644381, 10757770644398, 10757770644404, 10757770644411, 10757770644428, 10757770644435, 10757770644442, 10757770644459, 10757770644466, 10757770644473, 10757770644480, 10757770644497, 10757770644503, 10757770644510, 10757770644527, 10757770644534, 10757770644541, 10757770644558, 10757770644602, 10757770644619, 10757770644626, 10757770644633, 10757770644640, 10757770644657, 10757770644664, 10757770644671, 10757770644688, 10757770644695, 10757770644701, 10757770644718, 10757770644725, 10757770644732, 10757770644749, 10757770644756, 10757770644763, 10757770644770, 10757770644787, 10757770644794, 10757770644800, 10757770644817, 10757770644824, 10757770644831, 10757770644848, 10757770644855, 10757770644862, 10757770644879, 10757770644886, 10757770644893, 10757770644909, 10757770644916, 10757770644923, 10757770644930, 10757770644947, 10757770644954, 10757770644961, 10757770644978, 10757770644985, 10757770644992, 10757770645005, 10757770645012, 10757770645029, 10757770645036, 10757770645043, 10757770645050, 10757770645067, 10757770645074, 10757770645081, 10757770645098, 10757770645104, 10757770645111, 10757770645128, 10757770645135, 10757770645142, 10757770645159, 10757770645166, 10757770636584, 10757770645173, 10757770645180, 10757770645197, 10757770645203, 10757770645210, 10757770645227, 10757770645234, 10757770645241, 10757770645258, 10757770645265, 10757770645272, 10757770645289, 10757770645296, 10757770645302, 10757770645319, 10757770645326, 10757770645333, 10757770645340, 10757770645357, 10757770645364, 10757770645371, 10757770645388, 10757770645395, 10757770645401, 10757770645418, 10757770645425, 10757770645432, 10757770636591, 10757770645449, 10757770645456, 10757770645463, 10757770645470, 10757770645487, 10757770645494, 10757770645500, 10757770645517, 10757770645524, 10757770645531, 10757770645548, 10757770645555, 10757770645562, 10757770645579, 10757770645586, 10757770645593, 10757770645609, 10757770645616, 10757770645623, 10757770645630, 10757770645647, 10757770645654, 10757770645661, 10757770645678, 10757770645685, 10757770645692, 10757770645708, 10757770636607

Quantity recalled48,237

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1680-2025
FDA event ID: 96594
Recalling firm: Bausch & Lomb Surgical, Clearwater, FL
Classification: Class I
Status: Ongoing
Recall initiated: 27 Mar 2025
FDA classified: 2 May 2025
Reported: 14 May 2025
Type: Voluntary: Firm initiated
Customers notified by: Press Release
Reason category: Other Reasons
Device type: Contact Lenses & Eye Devices

Timeline

27 Mar 2025	Recall initiated by company
2 May 2025	Classified by FDA	+36 days
14 May 2025	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S.

Product as listed by the FDA

Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.

Where it was distributed

Worldwide distribution. US Nationwide including PR and GU, and the countries of CAN, AUS, AUT, BEL, BGR, IC, HRV, CZE, FRA, DEU, GRC, HUN, ITA, NLD, POL, PRT, ROU, ESP, GBR, NZL, HKG.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Which lots are affected?

Description/Lots/UDI-DI: enVista Envy IOL (ENU)/3Q24764, 3Q24935, 3Q25113, 3Q25833, 3Q26256, 3Q26257, 3Q26538, 3Q26601, 3Q26603, 3Q26604, 3Q26679, 3Q26680, 3Q27353, 3Q27447, 3Q27457, 3Q27905, 3Q27907, 3Q28001, 3Q28002, 3Q28124, 3Q28125, 3Q28801, 3Q28901, 3Q28903, 3Q28904, 3Q28905, 3Q28906, 3Q29020, 3Q29021, 3Q29205, 3Q29266, 3Q29301, 3Q29302, 3Q29304, 3Q29305, 3Q29306, 3Q29401, 3Q29403, 3Q29405, 3Q29406, 3Q29545, 3Q29547, 3Q29548, 3Q29636, 3Q29637, 3Q29835, 3Q29837, 3Q30210, 3Q30310, 3Q30311, 3Q33702, 3Q33822, 3Q33918, 3Q33921, 3Q33924, 3Q33925, 3Q33928, 3Q34031, 3Q34034, 3Q34205, 3Q35006, 3Q35733, 3Q35735, 3Q35736, 3Q35738, 3Q35813, 3R01610, 3R01611, 3R02532, 3R02534, 3R02536, 3R02537, 3R02540, 3R02542, 3R02551, 3R02553, 3R02608, 3R02749, 3R02750, 3R02846, 3R03533, 3R03534, 3R03536, 3R03804, 3R03805, 3R03806, 3R04414, 3R04533, 3R05051, 3R05411, 3Q24749, 3Q24750, 3Q24751, 3Q24756, 3Q24763, 3Q24765, 3Q24766, 3Q24837, 3Q24842, 3Q24934, 3Q25115, 3Q25116, 3Q25117, 3Q25118, 3Q25119, 3Q25421, 3Q25422, 3Q25423, 3Q25424, 3Q25506, 3Q25834, 3Q25922, 3Q25923, 3Q26525, 3Q26527, 3Q26539, 3Q26602, 3Q26605, 3Q27252, 3Q27321, 3Q27322, 3Q27323, 3Q27324, 3Q27354, 3Q27456, 3Q27458, 3Q27906, 3Q27908, 3Q28003, 3Q28004, 3Q28011, 3Q28012, 3Q28802, 3Q29017, 3Q29018, 3Q29022, 3Q29203, 3Q29204, 3Q29303, 3Q29402, 3Q29404, 3Q29546, 3Q29550, 3Q29635, 3Q30211, 3Q30213, 3Q32503, 3Q33816, 3Q33817, 3Q33818, 3Q33819, 3Q33820, 3Q33821, 3Q33823, 3Q33920, 3Q33922, 3Q33926, 3Q33927, 3Q33929, 3Q34032, 3Q34033, 3Q34201, 3Q34202, 3Q34203, 3Q34204, 3Q34901, 3Q34903, 3Q35028, 3Q35031, 3Q35734, 3Q35812, 3R01612, 3R02136, 3R02535, 3R02539, 3R02541, 3R02543, 3R02601, 3R02602, 3R02603, 3R02607, 3R02710, 3R02711, 3R02845, 3R02848, 3R03411, 3R03502, 3R03643, 3R04411, 3R04412, 3R04531, 3R05048, 3R05049, 3R05052, 3R05627/ 10757770636478, 10757770637017, 10757770637031, 10757770637055, 10757770637079, 10757770637543, 10757770637093, 10757770637109, 10757770637536, 10757770637116, 10757770637123, 10757770637130, 10757770637147, 10757770637154, 10757770637161, 10757770637178, 10757770637185, 10757770637192, 10757770637208, 10757770637215, 10757770637222, 10757770637239, 10757770637246, 10757770637253, 10757770636485, 10757770637550, 10757770637277, 10757770637284, 10757770637291, 10757770637307, 10757770637314, 10757770637321, 10757770637338, 10757770637345, 10757770637352, 10757770637369, 10757770637376, 10757770637383, 10757770637390, 10757770637406, 10757770637413, 10757770637420, 10757770637437, 10757770637444, 10757770637451, 10757770637468, 10757770637475, 10757770637482, 10757770637499, 10757770637505, 10757770637512, 10757770637529, 10757770636492; enVista Envy Toric IOL (ETNU)/3Q25926, 3Q25930, 3Q26240, 3Q26426, 3Q26431, 3Q26435, 3Q26436, 3Q26440, 3Q26441, 3Q26621, 3Q26726, 3Q26727, 3Q26731, 3Q26819, 3Q26820, 3Q26910, 3Q26928, 3Q27216, 3Q27217, 3Q27219, 3Q27221, 3Q27223, 3Q27249, 3Q27250, 3Q27251, 3Q27264, 3Q27327, 3Q27330, 3Q27505, 3Q27506, 3Q27518, 3Q27742, 3Q27912, 3Q28007, 3Q28008, 3Q28009, 3Q28010, 3Q28013, 3Q28134, 3Q28136, 3Q28721, 3Q28809, 3Q28818, 3Q28908, 3Q28909, 3Q28910, 3Q29208, 3Q29210, 3Q29212, 3Q29409, 3Q29517, 3Q29642, 3Q29922, 3Q29959, 3Q29961, 3Q30005, 3Q30136, 3Q30137, 3Q30138, 3Q30139, 3Q30208, 3Q30309, 3Q30453, 3Q30454, 3Q30517, 3Q30646, 3Q30647, 3Q30725, 3Q30741, 3Q30744, 3Q30803, 3Q31102, 3Q31107, 3Q31108, 3Q31509, 3Q31540, 3Q31541, 3Q31543, 3Q31865, 3Q31866, 3Q31929, 3Q32003, 3Q32004, 3Q32005, 3Q32009, 3Q32010, 3Q32206, 3Q32209, 3Q32211, 3Q32330, 3Q32331, 3Q32439, 3Q32443, 3Q32525, 3Q32529, 3Q32530, 3Q32606, 3Q32735, 3Q32737, 3Q32743, 3Q32842, 3Q32844, 3Q32846, 3Q32851, 3Q32931, 3Q32932, 3Q33014, 3Q33015, 3Q33128, 3Q33203, 3Q33505, 3Q33508, 3Q33545, 3Q33604, 3Q33613, 3Q33721, 3Q33902, 3Q34121, 3Q34256, 3Q34258, 3Q34315, 3Q35117, 3Q35335, 3Q35430, 3Q35431, 3Q35432, 3Q35433, 3Q35532, 3Q35557, 3Q35624, 3Q35625, 3Q35626, 3Q35628, 3Q35631, 3Q35704, 3Q35741, 3Q35758, 3Q35942, 3R00250, 3R01019, 3R01604, 3R01905, 3R02801, 3R03722, 3R03807, 3R04116, 3Q24946, 3Q25501, 3Q25605, 3Q25606, 3Q25703, 3Q25704, 3Q25722, 3Q25723, 3Q25725, 3Q25740, 3Q25741, 3Q25835, 3Q25836, 3Q25838, 3Q25839, 3Q25924, 3Q25925, 3Q25928, 3Q25931, 3Q25932, 3Q25933, 3Q26003, 3Q26004, 3Q26011, 3Q26012, 3Q26013, 3Q26059, 3Q26060, 3Q26061, 3Q26062, 3Q26063, 3Q26075, 3Q26076, 3Q26077, 3Q26078, 3Q26079, 3Q26080, 3Q26101, 3Q26102, 3Q26211, 3Q26212, 3Q26213, 3Q26214, 3Q26215, 3Q26216, 3Q26217, 3Q26230, 3Q26231, 3Q26232, 3Q26233, 3Q26234, 3Q26235, 3Q26236, 3Q26237, 3Q26238, 3Q26239, 3Q26241, 3Q26259, 3Q26260, 3Q26320, 3Q26321, 3Q26322, 3Q26323, 3Q26324, 3Q26325, 3Q26326, 3Q26327, 3Q26427, 3Q26428, 3Q26430, 3Q26432, 3Q26433, 3Q26434, 3Q26437, 3Q26439, 3Q26442, 3Q26443, 3Q26523, 3Q26524, 3Q26620, 3Q26623, 3Q26624, 3Q26625, 3Q26626, 3Q26721, 3Q26722, 3Q26723, 3Q26724, 3Q26725, 3Q26728, 3Q26729, 3Q26730, 3Q26732, 3Q26821, 3Q26822, 3Q26823, 3Q26824, 3Q26901, 3Q26902, 3Q26903, 3Q26904, 3Q26905, 3Q26908, 3Q26909, 3Q26930, 3Q27218, 3Q27220, 3Q27222, 3Q27224, 3Q27225, 3Q27248, 3Q27256, 3Q27265, 3Q27325, 3Q27326, 3Q27328, 3Q27329, 3Q27331, 3Q27332, 3Q27333, 3Q27334, 3Q27335, 3Q27350, 3Q27351, 3Q27352, 3Q27449, 3Q27501, 3Q27502, 3Q27503, 3Q27504, 3Q27516, 3Q27517, 3Q27519, 3Q27624, 3Q27625, 3Q27626, 3Q27627, 3Q27628, 3Q27629, 3Q27743, 3Q27744, 3Q27745, 3Q27909, 3Q27910, 3Q27911, 3Q27913, 3Q27914, 3Q28005, 3Q28006, 3Q28014, 3Q28127, 3Q28129, 3Q28130, 3Q28131, 3Q28132, 3Q28133, 3Q28135, 3Q28228, 3Q28719, 3Q28806, 3Q28807, 3Q28808, 3Q28810, 3Q28907, 3Q28911, 3Q29104, 3Q29105, 3Q29106, 3Q29128, 3Q29129, 3Q29130, 3Q29206, 3Q29207, 3Q29209, 3Q29211, 3Q29213, 3Q29214, 3Q29307, 3Q29308, 3Q29309, 3Q29310, 3Q29311, 3Q29312, 3Q29407, 3Q29408, 3Q29410, 3Q29411, 3Q29412, 3Q29451, 3Q29452, 3Q29515, 3Q29516, 3Q29518, 3Q29519, 3Q29520, 3Q29522, 3Q29523, 3Q29643, 3Q29644, 3Q29645, 3Q29705, 3Q29706, 3Q29707, 3Q29708, 3Q29709, 3Q29710, 3Q29711, 3Q29712, 3Q29713, 3Q29801, 3Q29838, 3Q29920, 3Q29921, 3Q29923, 3Q29957, 3Q29958, 3Q29960, 3Q30001, 3Q30002, 3Q30003, 3Q30004, 3Q30140, 3Q30201, 3Q30202, 3Q30203, 3Q30204, 3Q30205, 3Q30206, 3Q30207, 3Q30209, 3Q30301, 3Q30302, 3Q30303, 3Q30305, 3Q30306, 3Q30307, 3Q30308, 3Q30403, 3Q30434, 3Q30435, 3Q30437, 3Q30439, 3Q30440, 3Q30515, 3Q30516, 3Q30520, 3Q30523, 3Q30635, 3Q30636, 3Q30637, 3Q30648, 3Q30649, 3Q30740, 3Q30742, 3Q30743, 3Q30746, 3Q30747, 3Q30748, 3Q30749, 3Q30801, 3Q30812, 3Q30814, 3Q30815, 3Q30816, 3Q30817, 3Q30818, 3Q30902, 3Q30903, 3Q30904, 3Q30926, 3Q30927, 3Q30939, 3Q30940, 3Q30941, 3Q30942, 3Q31006, 3Q31007, 3Q31008, 3Q31042, 3Q31043, 3Q31053, 3Q31054, 3Q31101, 3Q31103, 3Q31104, 3Q31105, 3Q31106, 3Q31109, 3Q31110, 3Q31213, 3Q31214, 3Q31218, 3Q31219, 3Q31237, 3Q31238, 3Q31239, 3Q31450, 3Q31507, 3Q31508, 3Q31539, 3Q31542, 3Q31544, 3Q31601, 3Q31604, 3Q31605, 3Q31606, 3Q31607, 3Q31608, 3Q31609, 3Q31610, 3Q31611, 3Q31715, 3Q31716, 3Q31717, 3Q31718, 3Q31719, 3Q31720, 3Q31721, 3Q31842, 3Q31843, 3Q31844, 3Q31867, 3Q31868, 3Q31928, 3Q31930, 3Q31931, 3Q31932, 3Q31933, 3Q32001, 3Q32002, 3Q32006, 3Q32007, 3Q32008, 3Q32011, 3Q32012, 3Q32037, 3Q32128, 3Q32129, 3Q32130, 3Q32131, 3Q32155, 3Q32156, 3Q32157, 3Q32158, 3Q32159, 3Q32160, 3Q32201, 3Q32202, 3Q32203, 3Q32204, 3Q32205, 3Q32207, 3Q32208, 3Q32210, 3Q32212, 3Q32328, 3Q32329, 3Q32408, 3Q32409, 3Q32410, 3Q32411, 3Q32412, 3Q32440, 3Q32441, 3Q32442, 3Q32444, 3Q32506, 3Q32521, 3Q32522, 3Q32523, 3Q32524, 3Q32526, 3Q32527, 3Q32528, 3Q32607, 3Q32704, 3Q32738, 3Q32739, 3Q32740, 3Q32741, 3Q32742, 3Q32744, 3Q32745, 3Q32843, 3Q32845, 3Q32847, 3Q32848, 3Q32849, 3Q32850, 3Q32929, 3Q32930, 3Q32933, 3Q32934, 3Q32935, 3Q32936, 3Q32937, 3Q33004, 3Q33008, 3Q33009, 3Q33010, 3Q33011, 3Q33012, 3Q33013, 3Q33016, 3Q33017, 3Q33018, 3Q33019, 3Q33101, 3Q33102, 3Q33103, 3Q33129, 3Q33130, 3Q33131, 3Q33132, 3Q33133, 3Q33134, 3Q33204, 3Q33206, 3Q33207, 3Q33208, 3Q33503, 3Q33504, 3Q33506, 3Q33507, 3Q33543, 3Q33544, 3Q33546, 3Q33548, 3Q33605, 3Q33606, 3Q33607, 3Q33611, 3Q33614, 3Q33718, 3Q33719, 3Q33720, 3Q33722, 3Q33723, 3Q33731, 3Q33732, 3Q33824, 3Q33825, 3Q33826, 3Q33827, 3Q33828, 3Q33829, 3Q33901, 3Q34122, 3Q34123, 3Q34124, 3Q34125, 3Q34126, 3Q34127, 3Q34209, 3Q34210, 3Q34211, 3Q34257, 3Q34316, 3Q34317, 3Q34319, 3Q34320, 3Q34321, 3Q34323, 3Q34324, 3Q34325, 3Q34326, 3Q34327, 3Q34328, 3Q34329, 3Q34330, 3Q34331, 3Q34334, 3Q34335, 3Q34336, 3Q34431, 3Q34432, 3Q34436, 3Q34438, 3Q34440, 3Q34516, 3Q34518, 3Q34521, 3Q34522, 3Q34523, 3Q34524, 3Q34527, 3Q34528, 3Q34529, 3Q34530, 3Q34532, 3Q34536, 3Q34537, 3Q34538, 3Q34628, 3Q34633, 3Q34712, 3Q34713, 3Q34715, 3Q34716, 3Q34719, 3Q34720, 3Q34729, 3Q34732, 3Q34745, 3Q34828, 3Q34831, 3Q34832, 3Q34833, 3Q34835, 3Q34836, 3Q34837, 3Q34839, 3Q34840, 3Q34842, 3Q34843, 3Q34845, 3Q34913, 3Q34914, 3Q34916, 3Q34919, 3Q34921, 3Q35022, 3Q35118, 3Q35119, 3Q35120, 3Q35122, 3Q35123, 3Q35126, 3Q35127, 3Q35174, 3Q35213, 3Q35217, 3Q35220, 3Q35223, 3Q35225, 3Q35226, 3Q35336, 3Q35337, 3Q35340, 3Q35341, 3Q35342, 3Q35346, 3Q35348, 3Q35350, 3Q35408, 3Q35429, 3Q35527, 3Q35528, 3Q35529, 3Q35530, 3Q35531, 3Q35534, 3Q35535, 3Q35536, 3Q35559, 3Q35560, 3Q35627, 3Q35629, 3Q35630, 3Q35703, 3Q35739, 3Q35740, 3Q35750, 3Q35842, 3Q35936, 3Q35937, 3Q35938, 3Q35939, 3Q35941, 3R00247, 3R00248, 3R00254, 3R00324, 3R00510, 3R00601, 3R00603, 3R00618, 3R00713, 3R01020, 3R01111, 3R01201, 3R01416, 3R01519, 3R01602, 3R01605, 3R01722, 3R01724, 3R01903, 3R02301, 3R02304, 3R02309, 3R02310, 3R02401, 3R02402, 3R02409, 3R02411, 3R02421, 3R02422, 3R02424, 3R02441, 3R02442, 3R02443, 3R02444, 3R02446, 3R02447, 3R02448, 3R02450, 3R02544, 3R02548, 3R02728, 3R02802, 3R02821, 3R02824, 3R02826, 3R03034, 3R03036, 3R03037, 3R03038, 3R03039, 3R03040, 3R03105, 3R03106, 3R03134, 3R03135, 3R03137, 3R03139, 3R03140, 3R03141, 3R03233, 3R03234, 3R03301, 3R03302, 3R03505, 3R03506, 3R03507, 3R03720, 3R03721, 3R03723, 3R03808, 3R03812, 3R04115, 3R04342, 3R04746, 3R05032, 3R05141/ 10757770640000, 10757770640017, 10757770640024, 10757770640031, 10757770640048, 10757770640055, 10757770640574, 10757770640062, 10757770640079, 10757770640086, 10757770640093, 10757770640109, 10757770640116, 10757770640123, 10757770640130, 10757770640147, 10757770640154, 10757770640161, 10757770640178, 10757770640185, 10757770640192, 10757770640208, 10757770640215, 10757770640222, 10757770640239, 10757770640246, 10757770640253, 10757770640260, 10757770640277, 10757770640284, 10757770640291, 10757770640307, 10757770640314, 10757770640321, 10757770640338, 10757770640345, 10757770640352, 10757770640369, 10757770640376, 10757770640383, 10757770640390, 10757770640406, 10757770640413, 10757770640420, 10757770640437, 10757770640444, 10757770640451, 10757770640468, 10757770640475, 10757770640482, 10757770640499, 10757770640505, 10757770640512, 10757770640529, 10757770640536, 10757770640543, 10757770640550, 10757770640567, 10757770640581, 10757770640598, 10757770640604, 10757770640611, 10757770640628, 10757770640635, 10757770640642, 10757770640659, 10757770640666, 10757770640673, 10757770640680, 10757770640697, 10757770640703, 10757770640710, 10757770640727, 10757770640734, 10757770640741, 10757770640758, 10757770640765, 10757770640772, 10757770640789, 10757770640796, 10757770640802, 10757770640819, 10757770640826, 10757770640833, 10757770640840, 10757770640857, 10757770640864, 10757770640871, 10757770640888, 10757770640895, 10757770640901, 10757770640918, 10757770640925, 10757770640932, 10757770640949, 10757770640956, 10757770640963, 10757770640970, 10757770640987, 10757770640994, 10757770641007, 10757770641014, 10757770641021, 10757770641038, 10757770641045, 10757770641052, 10757770641069, 10757770641076, 10757770641083, 10757770641090, 10757770641106, 10757770641113, 10757770641120, 10757770641137, 10757770641144, 10757770641151, 10757770641168, 10757770641175, 10757770641182, 10757770641199, 10757770641205, 10757770641212, 10757770641229, 10757770641236, 10757770641243, 10757770641250, 10757770641267, 10757770641274, 10757770641281, 10757770641298, 10757770641304, 10757770641311, 10757770641328, 10757770641335, 10757770641342, 10757770641359, 10757770641366, 10757770641373, 10757770641380, 10757770641397, 10757770641403, 10757770641410, 10757770641427, 10757770641434, 10757770641441, 10757770641458, 10757770641465, 10757770641472, 10757770641496, 10757770641502, 10757770641519, 10757770641526, 10757770641533, 10757770641540, 10757770641557, 10757770641564, 10757770641571, 10757770641588, 10757770641595, 10757770641601, 10757770641618, 10757770641625, 10757770641632, 10757770641649, 10757770641656, 10757770641663, 10757770641670, 10757770641687, 10757770641694, 10757770641700, 10757770641717, 10757770636553, 10757770641724, 10757770641731, 10757770641748, 10757770641755, 10757770641762, 10757770641779, 10757770641786, 10757770641793, 10757770641809, 10757770641816, 10757770641823, 10757770641830, 10757770641847, 10757770641854, 10757770641861, 10757770641878, 10757770641885, 10757770641892, 10757770641908, 10757770641915, 10757770641922, 10757770641939, 10757770641946, 10757770641953, 10757770641977, 10757770641984, 10757770641991, 10757770636560, 10757770642004, 10757770642011, 10757770642028, 10757770642035, 10757770642042, 10757770642059, 10757770642066, 10757770642073, 10757770642080, 10757770642097, 10757770642103, 10757770642110, 10757770642134, 10757770642141, 10757770642158, 10757770642165, 10757770642172, 10757770642189, 10757770642196, 10757770642202, 10757770642219, 10757770642226, 10757770642233, 10757770642240, 10757770642257, 10757770642264, 10757770642271, 10757770636577, 10757770642851, 10757770642868, 10757770642875, 10757770642882, 10757770642899, 10757770642905, 10757770642912, 10757770642929, 10757770642936, 10757770642943, 10757770642950, 10757770642967, 10757770642974, 10757770642981, 10757770642998, 10757770643001, 10757770643018, 10757770643025, 10757770643032, 10757770643049, 10757770643056, 10757770643063, 10757770643070, 10757770643087, 10757770643094, 10757770643100, 10757770643117, 10757770643124, 10757770643131, 10757770643148, 10757770643155, 10757770643162, 10757770643179, 10757770643186, 10757770643193, 10757770643209, 10757770643216, 10757770643223, 10757770643230, 10757770643247, 10757770643254, 10757770643261, 10757770643278, 10757770643285, 10757770643292, 10757770643308, 10757770643315, 10757770643322, 10757770643339, 10757770643346, 10757770643353, 10757770643360, 10757770643377, 10757770643384, 10757770643391, 10757770643407, 10757770643414, 10757770643469, 10757770643421, 10757770643438, 10757770643445, 10757770643452, 10757770643476, 10757770643483, 10757770643490, 10757770643506, 10757770643513, 10757770643520, 10757770643537, 10757770643544, 10757770643551, 10757770643568, 10757770643575, 10757770643582, 10757770643599, 10757770643605, 10757770643612, 10757770643629, 10757770643636, 10757770643643, 10757770643650, 10757770643667, 10757770643674, 10757770643681, 10757770643698, 10757770643704, 10757770643711, 10757770643728, 10757770643735, 10757770643742, 10757770643759, 10757770643766, 10757770643773, 10757770643780, 10757770643797, 10757770643803, 10757770643810, 10757770643827, 10757770643834, 10757770643841, 10757770643858, 10757770643865, 10757770643872, 10757770643889, 10757770643896, 10757770643902, 10757770643919, 10757770643926, 10757770643933, 10757770643940, 10757770643957, 10757770643964, 10757770643971, 10757770643988, 10757770643995, 10757770644008, 10757770644015, 10757770644022, 10757770644039, 10757770644046, 10757770644053, 10757770644060, 10757770644077, 10757770644084, 10757770644091, 10757770644107, 10757770644114, 10757770644121, 10757770644138, 10757770644145, 10757770644152, 10757770644169, 10757770644176, 10757770644183, 10757770644190, 10757770644206, 10757770644213, 10757770644220, 10757770644237, 10757770644244, 10757770644251, 10757770644268, 10757770644275, 10757770644282, 10757770644299, 10757770644305, 10757770644312, 10757770644329, 10757770644336, 10757770644343, 10757770644350, 10757770644367, 10757770644374, 10757770644381, 10757770644398, 10757770644404, 10757770644411, 10757770644428, 10757770644435, 10757770644442, 10757770644459, 10757770644466, 10757770644473, 10757770644480, 10757770644497, 10757770644503, 10757770644510, 10757770644527, 10757770644534, 10757770644541, 10757770644558, 10757770644602, 10757770644619, 10757770644626, 10757770644633, 10757770644640, 10757770644657, 10757770644664, 10757770644671, 10757770644688, 10757770644695, 10757770644701, 10757770644718, 10757770644725, 10757770644732, 10757770644749, 10757770644756, 10757770644763, 10757770644770, 10757770644787, 10757770644794, 10757770644800, 10757770644817, 10757770644824, 10757770644831, 10757770644848, 10757770644855, 10757770644862, 10757770644879, 10757770644886, 10757770644893, 10757770644909, 10757770644916, 10757770644923, 10757770644930, 10757770644947, 10757770644954, 10757770644961, 10757770644978, 10757770644985, 10757770644992, 10757770645005, 10757770645012, 10757770645029, 10757770645036, 10757770645043, 10757770645050, 10757770645067, 10757770645074, 10757770645081, 10757770645098, 10757770645104, 10757770645111, 10757770645128, 10757770645135, 10757770645142, 10757770645159, 10757770645166, 10757770636584, 10757770645173, 10757770645180, 10757770645197, 10757770645203, 10757770645210, 10757770645227, 10757770645234, 10757770645241, 10757770645258, 10757770645265, 10757770645272, 10757770645289, 10757770645296, 10757770645302, 10757770645319, 10757770645326, 10757770645333, 10757770645340, 10757770645357, 10757770645364, 10757770645371, 10757770645388, 10757770645395, 10757770645401, 10757770645418, 10757770645425, 10757770645432, 10757770636591, 10757770645449, 10757770645456, 10757770645463, 10757770645470, 10757770645487, 10757770645494, 10757770645500, 10757770645517, 10757770645524, 10757770645531, 10757770645548, 10757770645555, 10757770645562, 10757770645579, 10757770645586, 10757770645593, 10757770645609, 10757770645616, 10757770645623, 10757770645630, 10757770645647, 10757770645654, 10757770645661, 10757770645678, 10757770645685, 10757770645692, 10757770645708, 10757770636607

Where was it sold?

Worldwide distribution. US Nationwide including PR and GU, and the countries of CAN, AUS, AUT, BEL, BGR, IC, HRV, CZE, FRA, DEU, GRC, HUN, ITA, NLD, POL, PRT, ROU, ESP, GBR, NZL, HKG.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 96594

Reported	Class	Recall	Company	Reason	Where
14 May 2025	CLASS I	Intraocular lens recalled by Bausch & Lomb Surgical	Bausch & Lomb Surgical	Other	Nationwide

More recalls from Bausch & Lomb Surgical

All 10

Reported	Class	Recall	Company	Reason	Where
3 Sep 2025Device	CLASS III	Akreos, SKU: AO60P0300. Akreos intraocular lenses recalled	Bausch & Lomb Surgical	Other	AZ, CA
14 May 2025Device	CLASS I	Intraocular lens recalled by Bausch & Lomb Surgical	Bausch & Lomb Surgical	Other	Nationwide
9 Dec 2020Device	CLASS II	MX60ET (enhanced enVista Toric) enVista¿ One-Piece recalled	Bausch & Lomb Surgical	Other	Nationwide
22 Jul 2020Device	CLASS II	enVista one-piece hydrophobic acrylic toric intraocular recalled	Bausch & Lomb Surgical	Other	Nationwide
26 Dec 2018Device	CLASS II	enVista One Piece Hydrophobic Acrylic Intraocular lens recalled	Bausch & Lomb Surgical	Other	Nationwide

Other Contact Lenses & Eye Devices recalls

All 153

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	Pearle Vision 1 day (somofilcon A) Contact Lens recalled by CooperVision	CooperVision	Other	Nationwide
1 Apr 2026Device	CLASS II	Tecnis Eyhance Iol with Tecnis Simplicity" Delivery System recalled	AMO Puerto Rico Manufacturing	Device Malfunction	Nationwide
5 Nov 2025Device	CLASS II	Alcon PRECISION1 One-Day Contact Lenses, -2.25D recalled	Alcon Research	Sterility	19 states
1 Oct 2025Device	CLASS II	Sofmed Breathables, (stenfilcon A) contact lens recalled by CooperVision	CooperVision	Sterility	Nationwide
1 Oct 2025Device	CLASS II	Voyant 1-Day Premium Toric, (stenfilcon A) contact lens recalled	CooperVision	Sterility	Nationwide