Class 2 Device Recall Endo Ocular Directional Laser Probe

• Date Initiated by Firm: July 27, 2010
• Date Posted: September 30, 2010
• Recall Status: Terminated on October 05, 2010
• Recall Number: Z-2652-2010
• Recall Event ID: 56481
• Product Classification: Ophthalmic laser - Product Code HQF
• Product: Endo Ocular Directional Laser Probe, Lumenis Inc. Salt Lake City, UT STERILE EO
• Code Information: Model numbers: GA-0040061;, GA-0040062; GA-0040063; GA-0040064; GA-0040065 and GA-0040066 Lot numbers: 942439; 946478; 947498; 942440; 947496; 010120; and 947501
• Recalling Firm/ Manufacturer: Lumenis, Inc.; 3959 W 1820 S; Salt Lake City UT 84104
• For Additional Information Contact: Customer Service; 877-586-3647
• Manufacturer Reason for Recall: Firm did not have proper 510(K) clearance.
• FDA Determined Cause: Component change control
• Action: Lumenis sent letters to all customers on 7/27/10 instructing them to review their inventory, isolate affected product, complete a recall verification form and return all affected product to them.
• Quantity in Commerce: 250 probes (25 boxes, each containing 10 probes)
• Distribution: FL, IL, MD, CO and TX
• 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.