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Bausch & Lomb Surgical, Inc. recalls enVista One Piece Hydrophobic Acrylic Intraocular lens - Is indicated for primary implantation for the visual correc
Recalled December 26, 2018 · FDA recall Z-0628-2019 · Bausch & Lomb Surgical
Hazard
Cosmetic imperfections on the surface of some lenses. · FDA Class II
Units
70,440 units
Sold at
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.
Description
Cosmetic imperfections on the surface of some lenses.
Product
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.
Manufacturer(s)
Bausch & Lomb Surgical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →