FDA Recall
Terminated
STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses.
Recall: Z-1964-2016
·
Initiated May 2, 2016
Recall
- Recall Number
- Z-1964-2016
- Event Number
- 74067
- Firm
- Staar Surgical Co.
- FEI Number
- 2023826
- Product Code
- KYB
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- May 2, 2016
- Terminated
- November 15, 2016
- Address
- 1911 Walker Ave, Monrovia, CA, 91016-4846
Description
STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses.
Reason
The STAAR AQ Cartridge-FP may malfunction and may crack during loading or delivery of the IOL (Intraocular Lenses).
Action
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.
Distribution
US
Quantity
2,612 units