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Open, Classified

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.

FDA Recall Z-2252-2021 · Posted None

Recalling FirmDutch Ophthalmic USA, Inc.
Recall StatusOpen, Classified
Product CodeHQC
Date Initiated2019-05-21
Product Quantity16 boxes

Reason for Recall

Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line

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.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide Distribution in the states of AL, CA, CO, FL, MI

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K190875EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector)D.O.R.C. Dutch Ophthalmic Research Center (International) · 2019-09-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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