CLASS II Device recall · Reported 17 May 2017 · FDA Enforcement Report
Healon GV recalled by Abbott Medical Optics Inc.
Abbott Medical Optics Inc. (AMO) is recalling Healon GV. The recall was initiated on 1 Apr 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-2063-2017
- FDA event ID
- 77023
- Recalling firm
- Abbott Medical Optics Inc. (AMO), Santa Ana, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Apr 2017
- FDA classified
- 10 May 2017
- Reported
- 17 May 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Device type
- Other Medical Devices
Timeline
| 1 Apr 2017 | Recall initiated by company | |
| 10 May 2017 | Classified by FDA | +39 days |
| 17 May 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.
Product as listed by the FDA
Healon GV, Part No. 10294701, 10294801, 10200014, 10201014, 10202014, 10203014
Where it was distributed
US and worldwide: Austria Belgium Croatia Czech Republic Denmark Finland France Germany Great Britain Iceland Ireland Israel Italy Latvia Lebanon Lithuania Netherlands Norway Portugal Spain Sweden Switzerland Tunisia Turkey Russian Fed Guadeloupe Sri Lanka Australia China Hong Kong Indonesia Malaysia Singapore South Korea Taiwan Thailand Japan Chile Colombia Costa Rica Ecuador
Questions about this recall
Why was it recalled?
Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.
Which lots are affected?
UB32596, UB32571, UB32597, UB32577, UB32576
Where was it sold?
US and worldwide: Austria Belgium Croatia Czech Republic Denmark Finland France Germany Great Britain Iceland Ireland Israel Italy Latvia Lebanon Lithuania Netherlands Norway Portugal Spain Sweden Switzerland Tunisia Turkey Russian Fed Guadeloupe Sri Lanka Australia China Hong Kong Indonesia Malaysia Singapore South Korea Taiwan Thailand Japan Chile Colombia Costa Rica Ecuador
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.
Other products in this recall event
5 other products · FDA event 77023More recalls from Abbott Medical Optics Inc. (AMO)
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