CLASS II Device recall · Reported 9 Dec 2020 · FDA Enforcement Report
MX60ET (enhanced enVista Toric) enVista¿ One-Piece recalled
Bausch & Lomb Surgical is recalling MX60ET (enhanced enVista Toric) enVista¿ One-Piece Hydrophobic Acrylic Toric, distributed nationwide in the US. The recall was initiated on 7 Nov 2020 and the FDA has classified it as Class II.
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-0519-2021
- FDA event ID
- 86721
- Recalling firm
- Bausch & Lomb Surgical, Clearwater, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Nov 2020
- FDA classified
- 2 Dec 2020
- Reported
- 9 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 7 Nov 2020 | Recall initiated by company | |
| 2 Dec 2020 | Classified by FDA | +25 days |
| 9 Dec 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product may be missing toric axis marks.
Product as listed by the FDA
MX60ET (enhanced enVista Toric) enVista¿ One-Piece Hydrophobic Acrylic Toric Model MX60ET - Product Usage: The lens is intended for placement in the capsular bag.
Where it was distributed
US Nationwide distribution including in the states of FL, CA, MO, MN, TN, TX, MI, WA, UT, NH, and OH.
Nationwide CaliforniaFloridaMichiganMinnesotaMissouriNew HampshireOhioTennesseeTexasUtahWashington
Questions about this recall
Why was it recalled?
Product may be missing toric axis marks.
Which lots are affected?
Lot number: 3043816 Serial numbers: 3043816001 3043816002 3043816003 3043816004 3043816005 3043816006 3043816007 3043816008 3043816009 3043816010 3043816011 3043816012 3043816013 3043816014 3043816015 3043816016 3043816017 3043816018 3043816019 3043816020 3043816023 3043816024 3043816025 3043816026 3043816027 3043816028 3043816029 3043816030 3043816031
Where was it sold?
US Nationwide distribution including in the states of FL, CA, MO, MN, TN, TX, MI, WA, UT, NH, and OH.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
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