AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cutter and Irrigation Sleeve (Model Number NGP

FDA device recall Z-2096-2017 · posted 2017-05-16 · Terminated

Recall details

Recalling firm

Abbott Medical Optics Inc. (AMO)

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.

Action taken

An Urgent Field Safety notice was sent on 3/30/17 to inform customers that AMO has voluntarily initiated this Action because a possibility exists that, due to a packaging error, 20GA Vitrectomy Cutters may be found in a 25GA package and 25GA Vitrectomy Cutters may be found in a 20GA package. Use of a Vitrectomy Cutter that is a different size than expected could lead to the need to alter the surgical technique, including conjunctival dissection, incision enlargement and scleral sutures.

Root cause

Packaging process control

Status

Terminated

Product code

MLZ

Quantity affected

360 units total

Distribution

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

Date initiated

2017-03-30

Date posted

2017-05-16

Date terminated

2017-08-23

Location

Santa Ana, CA

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