FDA-Device2019-07-10Class II
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)
Johnson & Johnson Surgical Vision Inc
Hazard
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.
Sold states
US Distribution to states of: NC, NV, TX, NY, UT, C, MN, NY, WA, NJ, OH, NV, CA and Internationally to: Australia and Japan.
Affected count
392 units
Manufactured in
1700 E Saint Andrew Pl, N/A, Santa Ana, CA, United States
Products
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)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1893-2019Don't want to check this manually?
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