Bausch & Lomb Surgical, Inc. recalls enVista One Piece Hydrophobic Acrylic Intraocular lens - Is indicated for primary implantation for the visual correctio…
- Recall date
- November 5, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0628-2019
- FDA classification
- Class II
- Brand / firm
- Bausch & Lomb Surgical, Inc.
- Sold / distributed
- 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.
Why it was recalled
Cosmetic imperfections on the surface of some lenses.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
enVista One Piece Hydrophobic Acrylic Intraocular lens - Is indicated for primary implantation for the visual correction of aphakia in adult patients in whom the cataractous lens has been removed. The lens is intended for placement in the capsular bag.
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