Recall Z-1964-2016
Staar Surgical Co. · initiated May 2, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses.
Codes / lots: 1281706, 1282812
Reason for recall
The STAAR AQ Cartridge-FP may malfunction and may crack during loading or delivery of the IOL (Intraocular Lenses).
FDA-determined cause: Process control
Action taken
STAAR sent a Medical Device Recall Letter dated May 11, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. STAAR Surgical is recalling the STAAR AQ Cartridge-FP because it may malfunction and may crack during loading or delivery of the IOL. Customers with questions are instructed to contact their STAAR customer service representative at (800) 352-7842.
Details
- Recall number
- Z-1964-2016
- Initiated
- May 2, 2016
- Terminated
- November 15, 2016
- Product code
- KYB – Lens, Guide, Intraocular
- Quantity
- 2,612 units
- Distribution
- US
- Recalling firm
- Staar Surgical Co., Monrovia, CA