Alcon AcrySof IQ Toric IOL Recall Expanded for Post-Operative Inflammation
Alcon Research, Ltd. is expanding a recall of AcrySof IQ Toric intraocular lenses due to increased reports of post-operative inflammation in patients.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly identifies the agency classification as 'Class I', which corresponds to a reasonable probability of serious adverse health consequences or death, mandating a Critical severity score per the rubric.
Plain-English summary
Alcon Research, Ltd. is expanding a previous recall of AcrySof IQ ReSTOR and AcrySof IQ ReSTOR Toric intraocular lenses (IOLs) to include AcrySof IQ Toric models SN6AT6, SN6AT7, SN6AT8, and SN6AT9. The recall involves 43,651 units of these medical devices, which are intended for primary implantation in the capsular bag of the eye for visual correction.
The expansion is due to a continued increase in reports of post-operative inflammation in patients who received the affected AcrySof IQ Toric IOLs. The agency has classified this recall as Class I, indicating a reasonable probability that the use of the product will cause serious adverse health consequences or death.
The affected units were distributed internationally, specifically to Japan. Patients who have received these lenses should consult their healthcare providers regarding the reported inflammation and potential risks associated with the device.
The recalled product
- Product
- Expansion of previous recall of AcrySof IQ ReSTOR and AcrySof IQ ReSTOR Toric IOL; now to include AcrySof IQ Toric models SN6AT6, SN6AT7, SN6AT8, and SN6AT9. Intended for primary implantation in the capsular bag of the eye for visual correction.
- Manufacturer
- Alcon Research, Ltd.
- Affected units
- 43,651
Distribution
Distribution scope not specified by the agency.
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