Class 2 Device Recall TDC Vitrectomy Pack VGPC 25g

• Date Initiated by Firm: May 21, 2019
• Create Date: August 12, 2021
• Recall Status: Open, Classified
• Recall Number: Z-2252-2021
• Recall Event ID: 88162
• 510(K)Number: K190875
• Product Classification: Unit, phacofragmentation - Product Code HQC
• Product: The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack VGPC 25g , Product Number 8525.201.
• Code Information: Lot Number: 2000401997 Unique Device Identifier (UDI) 08717872021294
• Recalling Firm/ Manufacturer: Dutch Ophthalmic USA, Inc.; 10 Continental Dr Bldg 1; Exeter NH 03833-7507
• For Additional Information Contact: 603-778-6929
• Manufacturer Reason for Recall: Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line
• FDA Determined Cause: Under Investigation by firm
• Action: Dutch Ophthalmic Customers were contacted via their sales representative of the issue and then sent replacement infusion lines o/a June 28, 2019.
• Quantity in Commerce: 16 boxes
• Distribution: US Nationwide Distribution in the states of AL, CA, CO, FL, MI
• 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 = HQC