Bausch & Lomb Surgical, Inc. recalls enVista one-piece hydrophobic acrylic toric intraocular lens
Recalled Product
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.
Hazard / Issue
The toric axis marks were misaligned (from the expected position in relation to the haptics) on an implanted lens.
Issued by
FDA
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