Food, drugs, devices › Alcon Research, Ltd.
Device recall: ReSTOR intraocular lens and ReSTOR Toric intraocular lens. The Alcon AcrySof IQ ReSTOR and IQ ReSTOR Toric intraocular l
Alcon Research, Ltd. (Fort Worth, TX) initiated this device recall on 15 Apr 2015; FDA lists 1 product record under event 71630, classified Class I.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 4% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 30 Jun 2017. Initiation: voluntary: firm initiated. Alcon Research, Ltd. has 28 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Alcon Research, Ltd., Fort Worth, TX.
Reason for recall
"There are reports of post - operative inflammation and/or toxic anterior segment syndrome (TASS) after cataract surgery."
Distribution
"Distribution Japan, No US distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2323-2015 | 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… | 45,391 | Class I | Terminated | 19 Aug 2015 |
Context
Other enforcement events for Alcon Research, Ltd.
All 28 events for Alcon Research, Ltd.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "There are reports of post - operative inflammation and/or toxic anterior segment syndrome (TASS) after cataract surgery."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "Distribution Japan, No US distribution."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 30 Jun 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.