RecallRadar

FDA Device recall Z-2062-2017

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

On 2017-05-17 the FDA classified a Class II recall of Healon, Part No. 10290953, 10295210, 10200011, 10200012, 10201012, 10203012, 10213012, 10223012, 10290701, 10294751, 10295701 by Abbott Medical Optics Amo, citing 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.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2062-2017
ClassificationClass II
Statusterminated
Initiated2017-04-01
Published2017-05-17
Last updated2026-09-13 11:54 UTC
CompanyAbbott Medical Optics Amo
Distributionn/a

Product

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

Reason

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.

Identifiers

code_infoUB32602, UB32593, UB32514, UB32521, UB32579, UB32573, UB32599, UB32614, UB32616, UB32533

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2062-2017%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.