Bausch & Lomb Recalls Toric Intraocular Lenses Due to Missing Axis Marks
Bausch & Lomb is recalling 31 MX60ET toric intraocular lenses because they may be missing toric axis marks, which are necessary for proper surgical placement.
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, and the hazard involves missing markings that could lead to improper placement, but no specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Bausch & Lomb Surgical, Inc. is recalling 31 units of the MX60ET (enhanced enVista Toric) enVista One-Piece Hydrophobic Acrylic Toric Model MX60ET intraocular lenses. The recall is due to a defect where the lenses may be missing toric axis marks. These marks are critical for surgeons to correctly orient the lens during placement in the capsular bag.
The affected devices are identified by Lot number 3043816 and specific serial numbers ranging from 3043816001 to 3043816031. The lenses were distributed nationwide in the United States, including in Florida, California, Missouri, Minnesota, Tennessee, Texas, Michigan, Washington, Utah, New Hampshire, and Ohio.
This recall is classified as Class II by the FDA. Healthcare providers and patients should verify the serial numbers of any implanted or pending lenses against the provided list. If a device is affected, it should be removed or replaced according to clinical judgment and FDA guidance.
The recalled product
- Product
- MX60ET (enhanced enVista Toric) enVista¿ One-Piece Hydrophobic Acrylic Toric Model MX60ET - Product Usage: The lens is intended for placement in the capsular bag.
- Manufacturer
- Bausch & Lomb Surgical, Inc.
- Affected units
- 31
Distribution
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