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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with reports of post-operative inflammation and TASS, which are significant adverse health events, but the source does not explicitly state fatalities or FDA Class I classification, placing it in the High severity category for risk-of-harm products.
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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