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STAAR Surgical AQ CARTRIDGE-FP (2016-05-11)
- Starting date:
- May 11, 2016
- Posting date:
- May 30, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Hospitals, Healthcare Professionals
- Identification number:
- RA-58630
Affected products
A. STAAR Surgical AQ CARTRIDGE-FP
Reason
Two (2) affected lots may not perform as intended in that the device may malfunction during use and in rare cases the cartridge may crack during use. One (1) injury was reported during use, an enlargement of the incision, with no further adverse patient impact.
Affected products
A. STAAR Surgical AQ CARTRIDGE-FP
Lot or serial number
1281706
1282812
Model or catalog number
AQ CARTRIDGE - FP
Companies
- Manufacturer
-
STAAR Surgical Company
1911 WALKER AVENUE
MONROVIA
91016
California
UNITED STATES