Recall Z-1747-2013— Staar Surgical Co.
Class II · Terminated
Class II FDA medical device recall by Staar Surgical Co., initiated 2013-06-10, terminated 2013-10-17. FDA's recall record names no specific 510(k) clearance for this event. Product: Afinity CQ2015A Intraocular Lens The visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction.. Reason: STAAR Surgical Company is recalling a limited number of nanoFLEX CC4204A and Afinity CQ2015A intraocular lenses due to the potential presence of glass particles in the storage vial..
- Recalling firm
- Staar Surgical Co.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-06-10
- Terminated
- 2013-10-17
- Firm location
- Monrovia, CA, United States
Product description
Afinity CQ2015A Intraocular Lens The visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction.
Reason for recall
STAAR Surgical Company is recalling a limited number of nanoFLEX CC4204A and Afinity CQ2015A intraocular lenses due to the potential presence of glass particles in the storage vial.
Data sourced from openFDA. This site is unofficial and independent of the FDA.