Alcon ReSTOR Intraocular Lenses Recalled for Post-Operative Inflammation Reports
Alcon Research, Ltd. is recalling ReSTOR intraocular lenses manufactured for Japan due to reports of post-operative inflammation and toxic anterior segment syndrome (TASS). No US distribution occurred.
The agency’s classification
FDA (Devices): Class I
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "There are reports of post - operative inflammation and/or toxic anterior segment syndrome (TASS) after cataract surgery."
Plain-English summary
Alcon Research, Ltd. is recalling the ReSTOR intraocular lens and ReSTOR Toric intraocular lens. These are posterior chamber lenses intended as optical implants designed to replace the human crystalline lens in adult patients following cataract surgery. The specific lenses subject to this correction are manufactured for Japan, and the source text confirms there was no US distribution. The recall involves 45,391 units across model numbers SN6AD1, SN6AD3, SV25T0, MN6AD1, SND1T3, SND1T4, SND1T5, and SND1T6, covering all lot numbers.
The recall is being conducted due to reports of post-operative inflammation and/or toxic anterior segment syndrome (TASS) after cataract surgery. TASS is a specific inflammatory reaction that can occur in the eye following surgery. The source text does not provide specific dates for the reports or additional details on the extent of the inflammation beyond the named conditions.
Because the lenses were distributed only in Japan, US consumers and patients are not affected by this specific recall action. Patients in Japan who have had these lenses implanted should consult their ophthalmologist regarding the reported issues.
The recalled product
- 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.…
- Manufacturer
- Alcon Research, Ltd.
- Affected units
- 45,391
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Model Numbers: SN6AD1
- SN6AD3
- SV25T0
- MN6AD1
- SND1T3
- SND1T4
- SND1T5 and SND1T6 and all lot numbers.
Distribution
Distribution scope not specified by the agency.
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