Reported Jul 10, 2019 · Terminated
Disposable 25GA Vitrectomy Cutter, REF NGP0025, RX Only, Abbott Medical Optics Inc., The product provides the item…
Johnson & Johnson Surgical Vision Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Johnson & Johnson Surgical Vision Inc · 1700 E Saint Andrew Pl · Santa Ana, CA · 92705-4933
Is this the product you have?
- 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)
- Lot codes and dates
- Lot Number60084881 Mfg
- date2017-09-05 Exp
- date2020-09-05
- UDI(01)05050474534117 (17)200905(10)60084881
- Amount recalled
- 392 units
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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