Recall Z-1893-2019— Johnson & Johnson Surgical Vision Inc

Name: FDA recall Z-1893-2019
Creator: U.S. Food and Drug Administration
Published: 2018-09-24

Class II · Terminated

Class II FDA medical device recall by Johnson & Johnson Surgical Vision Inc, initiated 2018-09-24. It names one FDA 510(k) clearance: K081681. 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). 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..

Recalling firm: Johnson & Johnson Surgical Vision Inc
Classification: Class II
Status: Terminated
Initiated: 2018-09-24
Firm location: Santa Ana, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K081681 — VITRECTOMY CUTTER AND ACCESSORIESAdvanced Medical Optics, Inc.·cleared 2008-10-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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)

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.