Staar Surgical Recalls STAAR AQ Cartridge-FP Intraocular Lens Delivery Systems
Staar Surgical Co. is recalling 2,612 units of the STAAR AQ Cartridge-FP because the device may crack during loading or delivery of intraocular lenses.
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, and the device presents a risk of harm (cracking during delivery) without reported injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Staar Surgical Co. is recalling 2,612 units of the STAAR AQ Cartridge-FP, a guide and delivery system for intraocular lenses. The recall was initiated because the device may malfunction and crack during the loading or delivery of the lenses.
The affected units were distributed in the United States. The recall involves specific product codes 1281706 and 1282812.
Consumers and healthcare providers should stop using the affected devices and contact the manufacturer for further instructions.
The recalled product
- Product
- STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses.
- Manufacturer
- Staar Surgical Co.
- Category
- Medical Device — Ophthalmic
- Affected units
- 2,612
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 (2)
- 1281706
- 1282812
Distribution
Distribution scope not specified by the agency.
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