Recall Z-2096-2017— Abbott Medical Optics Inc. (AMO)

Name: FDA recall Z-2096-2017
Creator: U.S. Food and Drug Administration
Published: 2017-03-30

Class II · Terminated

Class II FDA medical device recall by Abbott Medical Optics Inc. (AMO), initiated 2017-03-30, terminated 2017-08-23. It names one FDA 510(k) clearance: K081681. Product: AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cutter and Irrigation Sleeve (Model Number NGP0020) Used with the AMO Whitestar Signature System. For ophthalmic use.. Reason: Packaging error. 20GA Vitrectomy Cutters may be found in a 25GA package and 25GA Vitrectomy Cutters may be found in a 20GA package..

Recalling firm: Abbott Medical Optics Inc. (AMO)
Classification: Class II
Status: Terminated
Initiated: 2017-03-30
Terminated: 2017-08-23
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

AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cutter and Irrigation Sleeve (Model Number NGP0020) Used with the AMO Whitestar Signature System. For ophthalmic use.

Reason for recall

Packaging error. 20GA Vitrectomy Cutters may be found in a 25GA package and 25GA Vitrectomy Cutters may be found in a 20GA package.

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