Bausch & Lomb Recalls enVista Toric Intraocular Lenses Due to Axis Misalignment
Bausch & Lomb is recalling five enVista toric intraocular lenses because the toric axis marks were misaligned on an implanted lens.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (intraocular lens) where the defect (axis misalignment) could lead to suboptimal vision, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Bausch & Lomb Surgical, Inc. is recalling five units of the enVista one-piece hydrophobic acrylic toric intraocular lens (Model MX60ET, Catalog MXUET, Lot 3043212). The recall was initiated because the toric axis marks were found to be misaligned from the expected position in relation to the haptics on an implanted lens.
The affected lenses were distributed nationwide in the United States, including in Indiana, South Carolina, Connecticut, Nevada, and North Carolina. The specific serial numbers involved are 3043212002, 3043212005, 3043212006, 3043212007, and 3043212008.
This recall is classified as Class II by the FDA. Healthcare providers and patients should contact Bausch & Lomb Surgical for further instructions regarding the removal or replacement of these devices.
The recalled product
- 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 f
- Manufacturer
- Bausch & Lomb Surgical, Inc.
- Affected units
- 5
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Model number: MX60ET
- 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)
Distribution
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