Bausch & Lomb Recalls AKREOS AO Micro Incision Lenses Due to Material Error
Bausch & Lomb is recalling 336 AKREOS AO Micro Incision Lenses because they were manufactured with incorrect raw material. The lenses are intended for cataract surgery.
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 3/5 (High).
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. Per the rubric, a Class II recall without explicit reports of hospitalization or significant injury falls under the 'High' severity category, representing a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Bausch & Lomb Surgical, Inc. is recalling 336 units of the AKREOS AO Micro Incision Lens (IOL). The recall affects Model Numbers AO60 and MI60L. The product is intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients.
The recall was initiated because the lenses were manufactured with incorrect raw material. A total of 283 units were distributed in the United States, and 53 units were distributed internationally to Great Britain, France, Spain, Portugal, Sweden, Russia, and Guadeloupe.
Patients who have had these lenses implanted should contact their eye care professional for guidance. The FDA has classified this recall as Class II, which means use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients.
- Manufacturer
- Bausch & Lomb Surgical, Inc.
- Category
- Medical Device — Ophthalmic
- 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 (1)
- Model Numbers(s): AO60 and MI60L
Distribution
Distributed nationwide across the United States.
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