ClearanceBrief
Recall Z-1747-2013 ยท HQL Intraocular Lens

Staar Surgical Co.

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.

DateJul 17, 2013 (initiated Jun 10, 2013)
StatusTerminated
ReasonSTAAR 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.
Root causeMaterial/Component Contamination
ActionThe 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: customerservice@staar.com; and/or fax: 1-800-952-4923; return listed lenses to STAAR Surgical; complete and return the
Quantity3,361 units total
DistributionNationwide 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.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.