Reported Jul 22, 2020 · Terminated
enVista one-piece hydrophobic acrylic toric intraocular lens, Bausch and Lomb - Product Usage: is indicated for primary…
Bausch & Lomb Surgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bausch & Lomb Surgical, Inc. · 21 N Park Place Blvd · Clearwater, FL · 33759-3917
Is this the product you have?
- enVista one-piece hydrophobic acrylic toric intraocular lens
- Bausch and Lomb - Product Usageis 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
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Barcodes Product as published MX60ETCatalog number: MXUET — Lot numbers — 1075777055519910757770555199107577705551991075777055519910757770555199Lot 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) - Amount recalled
- 5
Where it was sold
Why it was recalled
The toric axis marks were misaligned (from the expected position in relation to the haptics) on an implanted lens.
This product could cause temporary or reversible health problems — stop using it.
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