Class 2 Device Recall NonCertified laser diode component

• Date Initiated by Firm: December 13, 2017
• Create Date: June 02, 2018
• Recall Status: Terminated on April 22, 2020
• Recall Number: Z-1614-2018
• Recall Event ID: 80020
• Product Classification: unknown device name - Product Code N/A
• Product: 11-VI Incorporated Laser diode component Non-certified laser diode component used in laser sights for firearms
• Code Information: Model Numbers: 25-0655 & 25-0657
• Recalling Firm/ Manufacturer: Ii - Vi Incorporated; 375 Saxonburg Blvd; Saxonburg PA 16056-9430
• For Additional Information Contact: 724-352-4455
• Manufacturer Reason for Recall: Affected diodes incorporated in the laser sights emitted greater than the 5 mW limit.
• FDA Determined Cause: Device Design
• Action: Please note that II-VI Inc. is responsible for the correction of all noncompliant products should the reported epoxy processing defect adversely affect any other laser diodes manufactured by II-VI, Inc. The single customer, Crimson Trace Corporation CTC was formally notified by you in writing. The defective laser diodes, models 25-0655 & 25-0657 will be or have already been replaced at no cost to CTC. The replacement will be done in batches and is expected to take approximately six to nine months, or no later than January 31, 2019. Defective laser diodes will be either returned to II-VI or destroyed at CTC. For further questions, please call (724) 352-4455.
• Quantity in Commerce: 323,972
• Distribution: US Distribution to Oregon.

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.