Abbott Medical Optics Inc. (AMO): 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.

Agency Publication Date: May 10, 2017

Affected Products

Product: Healon, Part No. 10290953, 10295210, 10200011, 10200012, 10201012, 10203012, 10213012, 10223012, 10290701, 10294751, 10295701

UB32602, UB32593, UB32514, UB32521, UB32579, UB32573, UB32599, UB32614, UB32616, UB32533

Product: Healon GV, Part No. 10294701, 10294801, 10200014, 10201014, 10202014, 10203014

UB32596, UB32571, UB32597, UB32577, UB32576

Product: Healon Duet, Part No. 10290080, 10220010, 10220011 and 10220012

UB32636

Product: Healon 5 Pro, Part No. 10270015

UB32526

Product: Healon Pro, Part No. 10270012

UB32524

Product: Healon V, Part No. 10290045

UB32491

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 77023

Status: Resolved

Manufacturer: Abbott Medical Optics Inc. (AMO)

Manufactured In: United States

Units Affected: 6 products (293,867 units total)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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