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Recall Observatory FDA recall evidence

Device product

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)

Z-1893-2019

September 24, 2018

Class II

Product summary

Firm
Johnson & Johnson Surgical Vision Inc
Event
Event 82868
Status
Terminated
Classification
Class II
Quantity
392 units
Official record key
device-enforcement:Z-1893-2019

Official wording

Reason: 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.

Code information: Lot Number: 60084881 Mfg. date: 2017-09-05 Exp. date: 2020-09-05 UDI: (01)05050474534117 (17)200905(10)60084881

Distribution pattern: US Distribution to states of: NC, NV, TX, NY, UT, C, MN, NY, WA, NJ, OH, NV, CA and Internationally to: Australia and Japan.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Packaging error