STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses.
This recall has been terminated (originally issued May 2, 2016).
- Company
- Staar Surgical Co.
- Recall Initiated
- May 2, 2016
- Terminated
- November 15, 2016
- Recall Number
- Z-1964-2016
- Quantity
- 2,612 units
- Firm Location
- Monrovia, CA
- Official Source
- View on FDA website ↗
Reason for Recall
The STAAR AQ Cartridge-FP may malfunction and may crack during loading or delivery of the IOL (Intraocular Lenses).
Distribution
US
Lot / Code Info
1281706, 1282812
Root 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.
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