CLASS II Device recall · Reported 22 Jul 2020 · FDA Enforcement Report
enVista one-piece hydrophobic acrylic toric intraocular recalled
Bausch & Lomb Surgical is recalling enVista one-piece hydrophobic acrylic toric intraocular lens, Bausch and Lomb, distributed nationwide in the US. The recall was initiated on 9 Jun 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-2552-2020
- FDA event ID
- 85862
- Recalling firm
- Bausch & Lomb Surgical, Clearwater, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Jun 2020
- FDA classified
- 10 Jul 2020
- Reported
- 22 Jul 2020
- 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
| 9 Jun 2020 | Recall initiated by company | |
| 10 Jul 2020 | Classified by FDA | +31 days |
| 22 Jul 2020 | 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
The toric axis marks were misaligned (from the expected position in relation to the haptics) on an implanted lens.
Product as listed by the FDA
enVista one-piece hydrophobic acrylic toric intraocular lens, Bausch and Lomb - Product Usage: is indicated for primary implantation in the capsular bag of the eye in adult patients for visual correction of aphakia and corneal astigmatism following removal of a cataractous lens for improved uncorrected distance vision.
Where it was distributed
U.S. Nationwide distribution including in the states of IN, SC, CT, NV, and NC.
Questions about this recall
Why was it recalled?
The toric axis marks were misaligned (from the expected position in relation to the haptics) on an implanted lens.
Which lots are affected?
Model number: MX60ET, Catalog number: MXUET Lot numbers: Lot Number 3043212 Serial Numbers: 3043212002 (UDI (01)10757770555199(17)230131(21)3043212002); 3043212005 (UDI (01)10757770555199(17)230131(21)3043212005); 3043212006 (UDI (01)10757770555199(17)230131(21)3043212006); 3043212007 (UDI (01)10757770555199(17)230131(21)3043212007); 3043212008 (UDI (01)10757770555199(17)230131(21)3043212008)
Where was it sold?
U.S. Nationwide distribution including in the states of IN, SC, CT, NV, and NC.
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.
More recalls from Bausch & Lomb Surgical
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|---|---|---|---|---|---|
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| Device | CLASS I | Intraocular Lens recalled by Bausch & Lomb Surgical | Bausch & Lomb Surgical | Other | Nationwide |
| Device | CLASS II | MX60ET (enhanced enVista Toric) enVista¿ One-Piece recalled | Bausch & Lomb Surgical | Other | Nationwide |
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