Intraocular lenses recalled after off-power error produced wrong diopter strength
Two Akreos intraocular lenses from lot 1Q29212 are recalled after an off-power error produced a 16 diopter lens rather than the intended 3 diopter.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; the notice states an implanted lens of the wrong power could cause visual impairment requiring correction, and no injuries are reported.
Plain-English summary
Akreos intraocular lenses, SKU AO60P0300, UDI-DI 10757770501783, are being recalled from lot 1Q29212, specifically serial numbers 1Q29212006 and 1Q29212010. The recall covers 2 units distributed in Arizona and California.
An off-power error was identified, which resulted in a diopter of 16 rather than the intended 3 diopter. The manufacturer states that implantation of an affected intraocular lens could result in functional visual impairment or a reduction in visual acuity, which could require optical or surgical correction. The FDA classified the action as Class III.
Surgical centres holding these serial numbers should quarantine them and follow the manufacturer's instructions for return.
The recalled product
- Product
- Akreos, SKU: AO60P0300. Akreos intraocular lenses
- Manufacturer
- Bausch & Lomb Surgical, Inc.
- Affected units
- 2
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 (3)
- UDI-DI: 10757770501783
- Lot: 1Q29212
- Serial Numbers: 1Q29212006 and 1Q29212010
Distribution
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