Abbott Medical Optics Inc. (AMO) recalls AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cutter and Irrigation Sleeve (Model Number NG…

Recall date

March 30, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2096-2017

FDA classification

Class II

Brand / firm

Abbott Medical Optics Inc. (AMO)

Sold / distributed

Worldwide distribution to SA, TR, AZ, NL, PT, SG, AU, JP, and HK.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.