Z-1964-2016 Class II Terminated
FDA device recall Z-1964-2016 was initiated by Staar Surgical Co. on May 2, 2016 and is designated Class II. Reason for recall: The STAAR AQ Cartridge-FP may malfunction and may crack during loading or delivery of the IOL (Intraocular Lenses). The recall status is terminated (terminated November 15, 2016). Affected quantity: 2,612 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 22, 2016
- Initiation Date
- May 2, 2016
- Termination Date
- November 15, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,612 units
Product Description
STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses.
Reason for Recall
The STAAR AQ Cartridge-FP may malfunction and may crack during loading or delivery of the IOL (Intraocular Lenses).
Distribution Pattern
US
Code Information
1281706, 1282812