FDA Device recall Z-2323-2015
ReSTOR intraocular lens and ReSTOR Toric intraocular lens
- FDA Device
- Class I
- terminated
- Published 2015-08-19
On 2015-08-19 the FDA classified a Class I recall of ReSTOR intraocular lens and ReSTOR Toric intraocular lens by Alcon Research, citing there are reports of post - operative inflammation and/or toxic anterior segment syndrome (TASS) after cataract surgery.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2323-2015 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2015-04-15 |
| Published | 2015-08-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Alcon Research |
| Distribution | n/a |
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
There are reports of post - operative inflammation and/or toxic anterior segment syndrome (TASS) after cataract surgery.
Identifiers
| code_info | Model Numbers: SN6AD1, SN6AD3, SV25T0, MN6AD1,SND1T3, SND1T4, SND1T5 and SND1T6 and all lot numbers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2323-2015%22
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