Bausch & Lomb Recalls Algerbrush-II Ophthalmic Surgical Instruments
Bausch & Lomb is recalling Algerbrush-II surgical instruments because some units shipped with outdated operating instructions.
What this means for you
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Our severity reasoning: The recall is classified as FDA Class II, but the hazard is limited to outdated documentation (operating instructions) rather than a physical defect or contamination, fitting the criteria for minor labeling or documentation issues.
Plain-English summary
Bausch & Lomb, Inc. is proposing a Field Correction for the Algerbrush-II, a medical device used by surgeons in ophthalmic procedures to remove foreign bodies from the eye. The recall affects 2,487 units distributed domestically in the USA and 1,211 units distributed internationally.
The recall was initiated after a packaging operator reported that operating instructions were not placed into the last repackaging of SKU 0816 C. Further investigation revealed that repackaged Algerbrush-II units and accessories from April 30, 2012, to the present contained outdated operating instructions. The affected SKUs are E0815 A, E0815 B, E0815 0.5, E0815 1.0, and E0816 C.
Bausch & Lomb is providing the current operating instructions to customers who purchased the product between April 30, 2012, and June 20, 2016. This action is classified as a Class II recall by the FDA.
The recalled product
- Product
- Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic surgical procedures to remove foreign bodies from the eye of the patient
- Manufacturer
- Bausch & Lomb, Inc.
- Hazard
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 (7)
- LOT #(s) AND EXPIRATION DATES
- SERIAL #(s)
- ORDER #
- or OTHER IDENTIFICATION #(s): SKU E0815 A
- SKU E0815 B
- SKU E0815 0.5
- SKU E0815 1.0 and SKU E0816 C
Distribution
Distributed nationwide across the United States.
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