medical Class II Updated 2020-07-22

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

Distribution: Nationwide (United States)
Lot/Code Info: Model number: MX60ET, Catalog number: MXUET Lot numbers: Lot Number 3043212 Serial Numbers: 3043212002 (UDI (01)10757770555199(17)230131(21)3043212002); 3043212005 (UDI (01)10757770555199(17)230131(21)3043212005); 3043212006 (UDI (01)10757770555199(17)230131(21)3043212006); 3043212007 (UDI (01)10757770555199(17)230131(21)3043212007); 3043212008 (UDI (01)10757770555199(17)230131(21)3043212008)
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