Recall Z-1964-2016 ยท KYB Lens, Guide, Intraocular
Staar Surgical Co.
STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses.
| Date | May 2, 2016 |
| Status | Terminated |
| Reason | The STAAR AQ Cartridge-FP may malfunction and may crack during loading or delivery of the IOL (Intraocular Lenses). |
| Root cause | Process control |
| 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. |
| Quantity | 2,612 units |
| Distribution | US |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K940593 | DISPOSABLE MICROSTAAR INJECTOR Staar Sugical, Sep 19, 1994 |