—#139158

Product

CATARACT PACK 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate

FDA product code: OJK — Eye Tray
Device class: Class 2
Medical specialty: Ophthalmic
Affected lot / code info: Code: 900944 Lots: 141015772 exp. 10/31/15 141015772 exp. 10/31/15 150116981 exp. 1/31/16 150116827 exp. 2/28/16 150116828 exp. 2/28/16 150116829 exp. 2/28/16 150317866 exp. 4/30/16 150317867 exp. 4/30/16 150317868 exp. 4/30/16 150317869 exp. 4/30/16 150418428 exp. 4/30/16 150418426 exp. 4/30/16 150418427 exp. 4/30/16 150418585 exp. 5/31/16 150418586 exp. 5/31/16 150619298 exp. 6/30/16 150619299 exp. 6/30/16

Why it was recalled

Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.

Root cause (FDA determination)

Packaging

Action the firm took

Customed issued an "URGENT VOLUNTARY MEDICAL DEVICE RECALL" notification letter dated July 10, 2015 to all affected customers. The letter identified the product, problem, and actions to be taken by the customer.

Recalling firm

Firm: Customed, Inc Calle Igualdad Final # 7
Address: Fajardo, Puerto Rico 00738

Distribution

Distribution pattern: Distributed Only in Puerto Rico.

Timeline

Recall initiated: 2015-07-10
Posted by FDA: 2015-09-03
Terminated: 2017-04-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #139158. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.