CLASS III Device recall · Reported 12 Sep 2018 · FDA Enforcement Report
Zenlens Toric-Gas Permeable Contact lenses for Daily Wear recalled
Alden Optical is recalling Zenlens Toric-Gas Permeable Contact lenses for Daily Wear in a 10-cc polycarbonate vial, distributed in 13 states. The recall was initiated on 3 Jul 2018 and the FDA has classified it as Class III.
Check your package
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-2981-2018
- FDA event ID
- 80800
- Recalling firm
- Alden Optical, Lancaster, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 3 Jul 2018
- FDA classified
- 6 Sep 2018
- Reported
- 12 Sep 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Contact Lenses & Eye Devices
Timeline
| 3 Jul 2018 | Recall initiated by company | |
| 6 Sep 2018 | Classified by FDA | +65 days |
| 12 Sep 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Vials labeled for the prescriptions contained incorrect lenses
Product as listed by the FDA
Zenlens Toric-Gas Permeable Contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx) as follows: Zenlens FT(Front Toric); Zenlens Toric-Zenlens FT + MV (Front Toric+Microvault); Zenlens TPC-(Toric Peripheral Curve); Zenlens TPC + FT- (Toric Peripheral Curve + FrontToric) Zenlens TPC + MV- (Toric Peripheral Curve+Microvault). Catalog Number: AOZNT Zenlens Toric - Zenlens contact lenses are indicated for daily wear for the correction of refractive arnetropia (myopia, hyperopia, and astigmatism) in aphakic and nonaphakic persons with non-diseased eyes.
Where it was distributed
US Distribution in the states of: CA, GA, IL, MD, NC, NJ, NV, OH, OK, PA, TN, TX and UT.
CaliforniaGeorgiaIllinoisMarylandNorth CarolinaNew JerseyNevadaOhioOklahomaPennsylvaniaTennesseeTexasUtah
Questions about this recall
Why was it recalled?
Vials labeled for the prescriptions contained incorrect lenses
Which lots are affected?
Lot Number/ Serial Number B3235820 UDI- (01)00785811435660/(10)18101PTC008 B3237820 UDI- (01)00785811435660/(10)18101PTC008 B3240210 UDI-(01)00785811435660/(10)18101PTC008 B3235420 UDI-(01)00785811435660/(10)18101PTC008 B3238610 UDI-(01)00785811435660/(10)18101PTC008 B3238620 UDI-(01)00785811435660/(10)18111PTC001 B3239510 UDI-(01)00785811435660/(10)18101PTC008 B3239520 UDI-(01)00785811435660/(10)18111PTC001 B3238210 UDI-(01)00785811435660/(10)18101PTC008 B3238220 UDI-(01)00785811435660/(10)18101PTC008 B3240510 UDI-(01)00785811435660/(10)18101PTC008 B3240520 UDI-(01)00785811435660/(10)18101PTC008 B3240720 UDI-(01)00785811435660/(10)18101PTC008 B3238510 UDI-(01)00785811435660/(10)18101PTC008 B3238710 UDI-(01)00785811435660/(10)18101PTC008 B3239620 UDI-(01)00785811435677/(10)18116PTC004 B3238120 UDI-(01)00865576000218/(10)P004732 B3225210 UDI-(01)00785811435660/(10)18101PTC008 B3225410 UDI-(01)00785811435660/(10)18101PTC008 B3225420 UDI-(01)00785811435660/(10)18101PTC008 B3239910 UDI-(01)00865576000201/(10)N003062 B3239920 UDI-(01)00865576000201/(10)N003062 B3236610 UDI-(01)00785811435660/(10)18101PTC008 B3240320 UDI-(01)00785811435660/(10)18101PTC008 B3238410 UDI-(01)00785811435660/(10)18101PTC008 B3238810 UDI-(01)00785811435677/(10)18116PTC004 B3238820 UDI-(01)00785811435677/(10)18116PTC004 B3235620 UDI-(01)00785811435660/(10)18101PTC008 B3240410 UDI-(01)00785811435660/(10)18101PTC008 B3240420 UDI-(01)00785811435660/(10)18101PTC008 B3235220 UDI-(01)00785811435660/(10)18101PTC008 B3237010 UDI-(01)00785811435677/(10)18116PTC004 B3237020 UDI-(01)00785811435677/(10)18116PTC004 B3236110 UDI-(01)00785811435660/(10)18101PTC008 B3236010 UDI-(01)00785811435660/(10)18101PTC008
Where was it sold?
US Distribution in the states of: CA, GA, IL, MD, NC, NJ, NV, OH, OK, PA, TN, TX and UT.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 80800| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Zen RC Toric-Gas permeable contact lenses for Daily Wear recalled | Alden Optical | Other | 13 states |
More recalls from Alden Optical
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | Zen RC Toric-Gas permeable contact lenses for Daily Wear recalled | Alden Optical | Other | 13 states |
| Device | CLASS II | Astera Multifocal Toric Daily Wear Soft contact recalled | Alden Optical | Sterility | Nationwide |
| Device | CLASS II | Alden HP59 Sphere Daily Wear Soft contact recalled by Alden Optical | Alden Optical | Sterility | Nationwide |
| Device | CLASS II | Alden HP54 Sphere Daily Wear Soft contact recalled by Alden Optical | Alden Optical | Sterility | Nationwide |
| Device | CLASS II | Alden HP54 Toric Daily Wear Soft contact recalled by Alden Optical | Alden Optical | Sterility | Nationwide |
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