The device is a 25-gauge infusion line that is part of… recallZ-2252-2021 · Dutch Ophthalmic USA, Inc. · initiated May 21, 2019
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Dutch Ophthalmic USA, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line
FDA root cause category: Under Investigation by firm
What the company is doing
Dutch Ophthalmic Customers were contacted via their sales representative of the issue and then sent replacement infusion lines o/a June 28, 2019.
Recall details
- Recall number
- Z-2252-2021
- Status
- Open, Classified
- Initiated by the company
- May 21, 2019
- Recalling firm
- Dutch Ophthalmic USA, Inc.
- Quantity
- 16 boxes
- Product code
- HQC
- FDA submissions
- K190875
- Distribution
- US Nationwide Distribution in the states of AL, CA, CO, FL, MI
Product description
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 (models, lots, serial numbers)
Lot Number: 2000401997 Unique Device Identifier (UDI) 08717872021294
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- EVA Custom TDC Vitrectomy Pack VGPC Input 25G 8525.201D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Instrument, Vitreous Aspiration And Cutting, Ac-Powered1 recall1 report
Other devices under the same FDA submission
21 devices cleared under K190875 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Disposable High Speed Cutter 23G/8000CPM 8267.VIT23D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Unit, Phacofragmentation22 reports
- EVA Vitrectomy Pack VGPC Input 23G 8300.23G02D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Instrument, Vitreous Aspiration And Cutting, Ac-Powered11 reports
- Disposable High Speed TDC Cutter 25 G / 8000 CPM DORC Continuum range 8268.VIT25D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Unit, Phacofragmentation10 reports
- Disposable High Speed TDC Cutter 23 G / 8000 CPM DORC Continuum range 8268.VIT23D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Unit, Phacofragmentation7 reports
- EVA TDC Vitrectomy Pack VGPC Input 23G 8310.23G02D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Unit, Phacofragmentation7 reports
- Disposable High Speed Cutter 25G/8000CPM 8267.VIT25D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Unit, Phacofragmentation6 reports
- Disposable High Speed Cutter 20G/8000CPM 8267.VIT20D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Unit, Phacofragmentation6 reports
- Disposable High Speed TDC Cutter 27 G / 8000 CPM DORC Continuum range 8268.VIT27D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Unit, Phacofragmentation5 reports
- EVA Vitrectomy Pack Gravity Input 23G 8300.23G01D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Unit, Phacofragmentation4 reports
- Universal PVC infusion line for 23G cannula system for VFI/VFE 1279.VFID.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Unit, Phacofragmentation3 reports
- Featherlight micro Phaco emulsification/fragmentation handpiece. 3002.MD.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Unit, Phacofragmentation3 reports
- EVA Vitrectomy Pack VGPC Input 25G 8300.25G02D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Unit, Phacofragmentation3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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