nanoFLEX CC4204A Intraocular Lens Correct aphakia in persons 60 years of age or older in whom a cataractous lens has bee

FDA device recall Z-1746-2013 · posted 2013-07-17 · Terminated

Recall details

Recalling firm

Staar Surgical Co.

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.

Action taken

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: customerservice@staar.com; 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

Status

Terminated

Product code

HQL

Quantity affected

3,361 units total

Distribution

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.

Date initiated

2013-06-10

Date posted

2013-07-17

Date terminated

2013-10-17

Location

Monrovia, CA