ReSTOR intraocular lens and ReSTOR Toric intraocular lens — Class I medical device recall Z-2323-2015
Terminated recall by Alcon Research, Ltd., reported 2015-08-19. There are reports of post - operative inflammation and/or toxic anterior segment syndrome (TASS) after catarac
| Recall number | Z-2323-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alcon Research, Ltd., Fort Worth, TX, United States |
| Recall initiated | 2015-04-15 |
| Classified | 2015-08-07 |
| Reported by FDA | 2015-08-19 |
| Terminated | 2017-06-30 |
| Countries outside the US | JP |
| Quantity | 45,391 |
| Model numbers | MN6AD1, SN6AD1, SN6AD3, SND1T3, SND1T4, SND1T5, SND1T6, SV25T0 |
Product
ReSTOR intraocular lens and ReSTOR Toric intraocular lens. The Alcon AcrySof IQ ReSTOR and IQ ReSTOR Toric intraocular lenses are posterior chamber lenses intended as optical implants designed to replace the human crystalline lens in adult patients following cataract surgery. The lenses subject to this correction are manufactured specifically for Japan.
Reason for recall
There are reports of post - operative inflammation and/or toxic anterior segment syndrome (TASS) after cataract surgery.
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-2323-2015. 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.