Abbott Healon EndoCoat Ophthalmic Viscosurgical Device 3% sodium… — Class II medical device recall Z-0530-2015
Terminated recall by Abbott Medical Optics Inc (AMO), reported 2014-12-17, distributed nationwide. AMO has received complaints where the finger grip dislodged while depressing the syringe plunger. The finger g
| Recall number | Z-0530-2015 |
|---|---|
| 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 | 2014-11-06 |
| Classified | 2014-12-08 |
| Reported by FDA | 2014-12-17 |
| Terminated | 2015-05-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, CA, CH, CL, CR, CZ, DE, DK, ES, FI, FR, GB, GT, HK, HN, HR, HU, IL, IT, KW, MX, MY, NL, NZ, PE, PT, RS, SA, SG, SI, TR, UA, VE |
| Lot numbers | 024992, 6-DIGIT, UP30729 |
| Model numbers | 57502000, VT585U |
Product
Abbott Healon EndoCoat Ophthalmic Viscosurgical Device 3% sodium hyaluronate 0.85 mL 30 mg/mL Sterile A Solution Sterile EO Packaging and Cannula Product of USA Abbott Healon Duet Dual Pack 0.55 ml OVD 0.85 ml Healon EndoCoat OVD Contents: -one sterile syringe of Healon Ophthalmic Viscosurgical Device (OVD) 0.55 ml (10 mg/ml Sodium Hyaluronate) -one sterile syringe of Healon EndoCoat Ophthalmic Viscosurgical Device (OVD) 0.85 ml (30 mg/ml Sodium Hyaluronate) Part Number: US: VT585U and 57502000 (packaged in Healon Duet 10290080) OUS: VT585 and 57550500 (packaged in Healon duet 10220010, 10220011 and 10220012)
Reason for recall
AMO has received complaints where the finger grip dislodged while depressing the syringe plunger. The finger grip dislodgement could result in the surgeon's hand unintentionally moving the cannula further than intended, resulting in potential trauma to the eye.
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-0530-2015. 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.