Healon GV — Class II medical device recall Z-2063-2017
Terminated recall by Abbott Medical Optics Inc. (AMO), reported 2017-05-17. Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage
| Recall number | Z-2063-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Medical Optics Inc. (AMO), Santa Ana, CA, United States |
| Recall initiated | 2017-04-01 |
| Classified | 2017-05-10 |
| Reported by FDA | 2017-05-17 |
| Terminated | 2017-11-27 |
| Countries outside the US | AT, AU, BE, CH, CL, CN, CO, CR, CZ, DE, DK, EC, ES, FI, FR, GB, HK, HR, ID, IE, IL, IS, IT, JP, KR, LB, LK, LT, LV, MY, NL, NO, PT, SE, SG, TH, TN, TR, TW |
| Quantity | 293,867 units |
| Reason classes | foreign material |
| Model numbers | 10200014, 10201014, 10202014, 10203014, 10294701, 10294801 |
Product
Healon GV, Part No. 10294701, 10294801, 10200014, 10201014, 10202014, 10203014
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2063-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.