Acrysof — Class II medical device recall Z-2287-2020
Terminated recall by Alcon Research LLC, reported 2020-06-17, distributed nationwide. Incorrect IOL diopter
| Recall number | Z-2287-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alcon Research LLC, Fort Worth, TX, United States |
| Recall initiated | 2020-04-17 |
| Classified | 2020-06-05 |
| Reported by FDA | 2020-06-17 |
| Terminated | 2021-02-05 |
| Distributed | Nationwide (US) |
| Quantity | 84 units |
| UPC / GTIN / UDI-DI | 00380652394772 |
| Lot numbers | 12726594 |
| Model numbers | AU00T0V205 |
Product
Acrysof, IQ IOL w/UltraSert System, AcrySof IQ ASPHERIC IOL, 20.5 D, SP ACRYLIC FOLDABLE LENS, w/UltraSert DELIVERY SYSTEM, UV w/BLUE LIGHT FILTER. 13.0mm. LENGTH, 6.0mm ANTERIOR ASYMMETRIC BICONVEX OPTIC, PLANAR HAPTICS.
Reason for recall
Incorrect IOL diopter
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-2287-2020. 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.