Class 2 Device Recall STAAR AQ CartridgeFP

• Date Initiated by Firm: May 02, 2016
• Create Date: June 14, 2016
• Recall Status: Terminated on November 15, 2016
• Recall Number: Z-1964-2016
• Recall Event ID: 74067
• 510(K)Number: K940593
• Product Classification: Lens, guide, intraocular - Product Code KYB
• Product: STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses.
• Code Information: 1281706, 1282812
• FEI Number: 2023826
• Recalling Firm/ Manufacturer: Staar Surgical Co.; 1911 Walker Ave; Monrovia CA 91016-4846
• For Additional Information Contact: 626-303-7902
• Manufacturer Reason for Recall: The STAAR AQ Cartridge-FP may malfunction and may crack during loading or delivery of the IOL (Intraocular Lenses).
• FDA Determined Cause: Process control
• Action: STAAR sent a Medical Device Recall Letter dated May 11, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. STAAR Surgical is recalling the STAAR AQ Cartridge-FP because it may malfunction and may crack during loading or delivery of the IOL. Customers with questions are instructed to contact their STAAR customer service representative at (800) 352-7842.
• Quantity in Commerce: 2,612 units
• Distribution: US
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KYB