Bausch & Lomb Recalls enVista Intraocular Lenses Due to Surface Imperfections
Bausch & Lomb is recalling 70,440 enVista intraocular lenses due to cosmetic surface imperfections. The lenses are distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the specific defect is described as 'cosmetic imperfections' with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Bausch & Lomb Surgical, Inc. is recalling 70,440 units of the enVista One Piece Hydrophobic Acrylic Intraocular lens. The recall is due to cosmetic imperfections found on the surface of some lenses. The affected product is indicated for primary implantation for the visual correction of aphakia in adult patients in whom the cataractous lens has been removed.
The recall includes Model MX60E and specific lots of various SKUs. The product was distributed nationwide to states including AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.
The FDA has classified this as a Class II recall. Consumers and healthcare providers should contact Bausch & Lomb Surgical, Inc. for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- enVista One Piece Hydrophobic Acrylic Intraocular lens - Is indicated for primary implantation for the visual correction of aphakia in adult patients in whom the cataractous lens has been removed. The lens is intended for placement in the capsular bag.
- Manufacturer
- Bausch & Lomb Surgical, Inc.
- Hazard
- Affected units
- 70,440
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 (20)
- Model MX60E and specific lots of the following SKU's: MXUE0000
- MXUE0100
- MXUE0200
- MXUE0300
- MXUE0400
- MXUE0500
- MXUE0600
- MXUE0700
- MXUE0800
- MXUE0900
- MXUE1000
- MXUE1050
- MXUE1100
- MXUE1150
- MXUE1200
- MXUE1250
- MXUE1300
- MXUE1350
- MXUE1400
- MXUE1450
Distribution
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