Bausch & Lomb enVista IOL Lenses with Cosmetic Imperfections - Recall
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.
Lower-risk recall
Cosmetic imperfections on the surface of some lenses.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/69501-bausch-lomb-envista-iol-lenses-with-cosmetic-imperfections-recall.
Source Summary by GovInfoNow · govinfonow.com/recall/69501-bausch-lomb-envista-iol-lenses-with-cosmetic-imperfections-recall · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0628-2019
Cite this page
“Bausch & Lomb enVista IOL Lenses with Cosmetic Imperfections - Recall.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69501-bausch-lomb-envista-iol-lenses-with-cosmetic-imperfections-recall. Based on FDA recall #Z-0628-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0628-2019%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Bausch & Lomb- Category
Medical device
What to do — step by step
Check Lens Model
Identify if your lens is model MX60E with the specific SKUs listed from MXUE0000 to MXUE3400.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 44 states.
FDA distribution: “US Nationwide Distribution: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL IN, KS, KY, la, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-0628-2019 (November 5, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0628-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.