Drug recall
ReSTOR intraocular lens and ReSTOR Toric intraocular lens. The Alcon AcrySof IQ ReSTOR and IQ ReSTOR Toric…
FDA recall event 71630 · Class I · Alcon Research, Ltd.
Key facts
| Event ID | 71630 |
|---|---|
| Recall numbers | Z-2323-2015 |
| Recalling firm | Alcon Research, Ltd. |
| Product type | Devices |
| Products | 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… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There are reports of post - operative inflammation and/or toxic anterior segment syndrome (TASS) after cataract surgery. |
| Initiation date | Apr 15, 2015 |
| Report date | Aug 19, 2015 |
| Termination date | Jun 30, 2017 |
| City | Fort Worth |
| State | TX |
| Country | United States |
| FEI number | 1610287 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: