Bausch & Lomb Surgical, Inc.: 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 adu

Is my product affected?

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 uncorrec

• UPC 10757770555199

Check against the official notice below — it lists the full affected range.

What happened

Bausch & Lomb Surgical is recalling five enVista one-piece hydrophobic acrylic toric intraocular lenses used for eye surgery. The lenses, which are implanted in the eye's capsular bag in adult patients, had misaligned toric axis marks that were not in the correct position relative to the lens haptics. The affected lenses are Model number MX60ET with Catalog number MXUET from Lot Number 3043212, with five specific serial numbers identified. These lenses were distributed nationwide in the United States, including in Indiana, South Carolina, Connecticut, Nevada, and North Carolina.

The recall affects only the five specific serial-numbered lenses listed in this notice. The source document does not specify a remedy or what actions affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

The toric axis marks were misaligned (from the expected position in relation to the haptics) on an implanted lens.

Details from the source

Reason for recall: The toric axis marks were misaligned (from the expected position in relation to the haptics) on an implanted lens. Distribution: U.S. Nationwide distribution including in the states of IN, SC, CT, NV, and NC. Quantity: 5 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)

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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