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.
FDA Recall Z-1747-2013 · Posted 2013-07-17
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Recalling FirmStaar Surgical Co.
Recall StatusTerminated
Product CodeHQL
Date Initiated2013-06-10
Date Terminated2013-10-17
Product Quantity3,361 units total
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.
Firm Action
The firm, STAAR Surgical, sent an "URGENT - MEDICAL DEVICE RECALL" letter dated June 10, 2013 to all the customers that received a limited number of nanoFLEX CC4204A and Afinity CQ2015 Intraocular lenses. The letter described the product, problem and actions to be taken. The customers were instructed to check your inventory; remove any lenses from the attached list; contact STAAR Surgical Customer Service for Returns Goods Authorization Number via phone: 1-800-352-7842; email: [email protected]; and/or fax: 1-800-952-4923; return listed lenses to STAAR Surgical; complete and return the attached response form by fax to Customer Service at (800) 952-4923, and pass this notice on to all those who need to be aware within your organization or any organization where the devices have been transferred.
If you have any questions or concerns regarding the product return, contact STAAR Surgical Customer Service at (800) 352-7842.
Root Cause
Material/Component Contamination
Distribution Pattern
Nationwide distribution: USA including states of: AL,AZ, CA, CO, CT, FL, GA, HI, KY, IA, IL, IN, LA, MA, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, PA, SC, TN, TX, UT, VA, WI, and WV.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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