Z-2096-2017Class II

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

Name: Z-2096-2017 AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cutter and Irrigation Sleeve (Model...
Creator: Abbott Medical Optics Inc. (AMO)
Published: 2017-03-30
License: https://open.fda.gov/license/

Advanced Medical Optics, Inc. / initiated 2017-03-30 / Terminated / root cause: packaging

FDA source

Abbott Medical Optics Inc. (AMO) began a recall of AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cutter and Irrigation Sleeve (Model Number NGP0020) Used with the AMO Whitestar... on 2017-03-30. FDA classified it as Class II and gives the reason as "Packaging error. 20GA Vitrectomy Cutters may be found in a 25GA package and 25GA Vitrectomy Cutters may be found in a 20GA package". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2096-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-30
Posted: 2017-05-16
Terminated: 2017-08-23
Recalling firm: Advanced Medical Optics, Inc.
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.
Product code: MLZ Vitrectomy, Instrument Cutter
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.
Root cause tag: packaging
FDA root cause: Packaging process control
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.
Quantity in commerce: 360 units total
Distribution: Worldwide distribution to SA, TR, AZ, NL, PT, SG, AU, JP, and HK.
Product codes and lots: Part Number NGP0025 Lot CA06182 (72 units) Part Number NGP0020 Lot CA06180 (288 units)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2096-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2096-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-24	2017-05-16

Product code MLZ

K081681Class IIVitrectomy Cutter and AccessoriesAdvanced Medical Optics, Inc. / cleared 2008-10-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)