FDA Enforcement
Class II
Terminated
STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses.
Recall: Z-1964-2016
·
Reported June 22, 2016
Enforcement
- Recall Number
- Z-1964-2016
- Event ID
- 74067
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Staar Surgical Co.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 22, 2016
- Initiation Date
- May 2, 2016
- Classification Date
- June 14, 2016
- Termination Date
- November 15, 2016
- Address
- 1911 Walker Ave, Monrovia, CA, 91016-4846, United States
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).
Code Info
1281706, 1282812
Distribution
US
Quantity
2,612 units