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U.S. Department of Health and Human Services

Class 2 Device Recall TDC Vitrectomy Pack VGPC 25g

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  Class 2 Device Recall TDC Vitrectomy Pack VGPC 25g see related information
Date Initiated by Firm May 21, 2019
Create Date August 12, 2021
Recall Status1 Open3, 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 2		 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 and Original Applicant = D.O.R.C. Dutch Ophthalmic Research Center (International)
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