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.
FDA Recall Z-2096-2017 · Posted 2017-05-16
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Recalling FirmAbbott Medical Optics Inc. (AMO)
Recall StatusTerminated
Product CodeMLZ
Date Initiated2017-03-30
Date Terminated2017-08-23
Product Quantity360 units total
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.
Firm Action
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
Distribution Pattern
Worldwide distribution to SA, TR, AZ, NL, PT, SG, AU, JP, and HK.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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