Bausch & Lomb recalls enVista One Piece Hydrophobic Acrylic Intraocular lenses with cosmetic imperfections on the surface. Affected models include MX60E and specific SKUs from MXUE0000 to MXUE3400.
Cosmetic imperfections on the surface of some lenses.
Bausch & Lomb is recalling certain enVista One Piece Hydrophobic Acrylic Intraocular lenses due to cosmetic imperfections on the surface. These imperfections do not affect safety but may cause visual issues during surgery.
Cosmetic imperfections on the lens surface could potentially cause visual issues during surgery. However, the lenses are designed for primary implantation in patients who have had their cataractous lens removed, and the imperfections do not pose a risk of injury or serious harm.
Patients who have been prescribed or are scheduled for surgery using the affected enVista lenses. Surgeons and ophthalmologists who use these lenses for cataract surgery are most at risk.
Check for the model MX60E and specific SKUs listed from MXUE0000 to MXUE3400. These lenses are used for cataract surgery in adults and are intended for placement in the eye's capsular bag.
Identify if your lens is model MX60E with the specific SKUs listed from MXUE0000 to MXUE3400.
No, the cosmetic imperfections do not pose a risk of injury or serious harm during surgery.
The recall does not specify a remedy, so contact Bausch & Lomb directly for guidance.
Yes, the lenses are safe for use but may have cosmetic imperfections that could affect visual outcomes during surgery.
We’ve drafted a message you can send Bausch & Lomb to request your refund or repair — edit it as you like.
Subject: Recall Z-0628-2019 — Bausch & Lomb Bausch & Lomb Hello, I own a Bausch & Lomb that is covered by recall Z-0628-2019 from Bausch & Lomb. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
