CLASS II Device recall · Reported 24 May 2017 · FDA Enforcement Report
AMO Vitrectomy Cutter recalled by Abbott Medical Optics Inc.
Abbott Medical Optics Inc. (AMO) is recalling AMO Vitrectomy Cutter (, distributed in Arizona. The recall was initiated on 30 Mar 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2096-2017
- FDA event ID
- 77024
- Recalling firm
- Abbott Medical Optics Inc. (AMO), Santa Ana, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Mar 2017
- FDA classified
- 16 May 2017
- Reported
- 24 May 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 30 Mar 2017 | Recall initiated by company | |
| 16 May 2017 | Classified by FDA | +47 days |
| 24 May 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution to SA, TR, AZ, NL, PT, SG, AU, JP, and HK.
Questions about this recall
Why was it recalled?
Packaging error. 20GA Vitrectomy Cutters may be found in a 25GA package and 25GA Vitrectomy Cutters may be found in a 20GA package.
Which lots are affected?
Part Number NGP0025 Lot CA06182 (72 units) Part Number NGP0020 Lot CA06180 (288 units)
Where was it sold?
Worldwide distribution to SA, TR, AZ, NL, PT, SG, AU, JP, and HK.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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