FDA-Device2018-12-26Class II
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.
Bausch & Lomb Surgical, Inc.
Hazard
Cosmetic imperfections on the surface of some lenses.
Sold states
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.
Affected count
70,440 units
Manufactured in
21 N Park Place Blvd, Clearwater, FL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0628-2019Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief