Class 2 Device Recall Peregrine Illuminated Laser Probe

• Date Initiated by Firm: April 14, 2021
• Create Date: July 20, 2021
• Recall Status: Open, Classified
• Recall Number: Z-2097-2021
• Recall Event ID: 88146
• 510(K)Number: K031023
• Product Classification: Laser, ophthalmic - Product Code HQF
• Product: Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrectomy system; Product Code: 7510.ALC
• Code Information: Lot Number(s) 039406 Unique Device Identifier (UDI) 08717872016122
• Recalling Firm/ Manufacturer: Dutch Ophthalmic USA, Inc.; 10 Continental Dr Bldg 1; Exeter NH 03833-7507
• For Additional Information Contact: SAME; 603-778-6929
• Manufacturer Reason for Recall: Barcode label extended expiration date. Barcode located at the short side of the outer box shows 2025-10-27 when scanned, while the correct expiry date is 2024-10-01
• FDA Determined Cause: Process control
• Action: Dutch Ophthalmic issued Urgent Medical Device Recall letter on 4/14/21 via Certified Mail. Letter states reason for recall, health risk and action to take: Verify whether you have unused boxes of LOT 039406 in your inventory and quarantine product subject to this safety notice. " If returned contact Customer Service at Dutch Ophthalmic, USA at 1-800-753- 8824 x 1 to receive a Return Material Authorization (RMA) number and receive instructions on how to return unused boxes of the impacted product. " If not returning, verify that expiry dates in any hospital system are showing the correct expiry date of 2024- 10-01. If not, please ensure the expiry date is modified to reflect the actual expiry date. " For opened boxes of LOT 039406, verify that expiry dates in any hospital system are showing the correct expiry date of 2024-10-01. If not, please ensure the expiry date is modified to reflect the actual expiry date. Complete the attached Urgent Medical Device Safety Notice Reconciliation Form, sign it and return a scan or photo of the signed form by email to d.clement@dorcglobal.com. " Add the original completed and signed Urgent Medical Device Safety Notice Reconciliation Form referencing the Return Material Authorization number with the product to be returned. In the next days our sales representative will contact you to discuss replacement of the to be returned boxes and to verify whether there are additional questions or actions in which we can assist. If in the meantime you need any further information or support concerning this issue, please contact our local representative at Dutch Ophthalmic USA at 1-800-753-8824 x 1 for assistance.
• Quantity in Commerce: 13 Boxes
• Distribution: Nationwide Distribution in the states of CA, FL, MA, and UT.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = HQF and Original Applicant = PEREGRINE SURGICAL LTD.