enVista Toric IOL recallZ-2552-2020 · Bausch & Lomb Surgical, Inc. · initiated Jun 9, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Bausch & Lomb Surgical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The toric axis marks were misaligned (from the expected position in relation to the haptics) on an implanted lens.
FDA root cause category: Unknown/Undetermined by firm
What the company is doing
On 06/09/2020, BAUSCH and LOMB's Sales Representatives contacted customers by telephone and email. In addition, the firm sent a letter to customers dated, June 17, 2020 and titled, "MEDICAL DEVICE VOLUNTARY PRODUCT RECALL". The letter informs customers about a voluntary recall of one lot of enhanced enVista MX60ET intraocular lenses (IOLs). Customers should quarantine product and return product to the firm. Customers should complete the enclosed Medical Device Voluntary Recall Acknowledgement Form and contact the firm to obtain a Return Material Authorization Number and arrange for pickup of the identified product. The contact information for Bausch and Lomb Surgical Customer Service is 1-800-338-2020, Customer Service (option 2).
Recall details
- Recall number
- Z-2552-2020
- Status
- Terminated
- Initiated by the company
- Jun 9, 2020
- Recalling firm
- Bausch & Lomb Surgical, Inc.
- Quantity
- 5
- Product code
- HQL
- FDA submissions
- P910056
- Distribution
- U.S. Nationwide distribution including in the states of IN, SC, CT, NV, and NC.
Product description
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.
Code information (models, lots, serial numbers)
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)
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- enVista® Toric IOL MX60ETBausch & Lomb Incorporated · intraocular lens1 recall1 report
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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