FDA-Device2020-07-22Class II
enVista one-piece hydrophobic acrylic toric intraocular lens, Bausch and Lomb - Product Usage: is indicated for primary implantation in the capsular bag of the eye in adult patients for visual correction of aphakia and corneal astigmatism following removal of a cataractous lens for improved uncorrected distance vision.
Bausch & Lomb Surgical, Inc.
Hazard
The toric axis marks were misaligned (from the expected position in relation to the haptics) on an implanted lens.
Sold states
U.S. Nationwide distribution including in the states of IN, SC, CT, NV, and NC.
Affected count
5
Manufactured in
21 N Park Place Blvd, N/A, Clearwater, FL, United States
Products
enVista one-piece hydrophobic acrylic toric intraocular lens, Bausch and Lomb - Product Usage: is indicated for primary implantation in the capsular bag of the eye in adult patients for visual correction of aphakia and corneal astigmatism following removal of a cataractous lens for improved uncorrected distance vision.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2552-2020Don't want to check this manually?
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