Disposable 25GA Vitrectomy Cutter, REF NGP0025, RX Only… recallZ-1893-2019 · Johnson & Johnson Surgical Vision Inc · initiated Sep 24, 2018
Terminated
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 Johnson & Johnson Surgical Vision 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
Packaging error, 20GA Vitrectomy Cutter may be found in a 25GA package. Use of a Vitrectomy cutter that is a different size than expected could lead to the need to alter the surgical technique, including corneal incision enlargement.
FDA root cause category: Packaging process control
What the company is doing
The firm, Johnson & Johnson Vision, sent an"URGENT MEDICAL DEVICE RECALL" Letter dated September 20, 2018 overnight on September 20, 2018 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: If you have received impacted product, please immediately take the following actions: 1. Review your inventory to identify units of affected lot; 2. Stop using and remove from your inventory all affected lot; and 3. regardless if you do not have inventory, please complete the Customer Reply form and return product. If you have questions, please contact the firm at 1-877-166-4543.
Recall details
- Recall number
- Z-1893-2019
- Status
- Terminated
- Initiated by the company
- Sep 24, 2018
- Recalling firm
- Johnson & Johnson Surgical Vision Inc
- Quantity
- 392 units
- Product code
- MLZ
- FDA submissions
- K081681
- Distribution
- US Distribution to states of: NC, NV, TX, NY, UT, C, MN, NY, WA, NJ, OH, NV, CA and Internationally to: Australia and Japan.
Product description
Disposable 25GA Vitrectomy Cutter, REF NGP0025, RX Only, Abbott Medical Optics Inc., The product provides the item necessary to perform one vitrectomy procedure. It is used to remove vitreous from the eye. It has been designed as a disposable (single use)
Code information (models, lots, serial numbers)
Lot Number: 60084881 Mfg. date: 2017-09-05 Exp. date: 2020-09-05 UDI: (01)05050474534117 (17)200905(10)60084881
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- DISPOSABLE 25GA VITRECTOMY CUTTER NGP0025Johnson & Johnson Surgical Vision, Inc. · VITRECTOMY, INSTRUMENT CUTTER1 recall7 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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