ACRYSOF® SN6AT6 (REF SN6AT6.230)Recalls & reported problems
Alcon Laboratories, Inc. · AcrySof(R) IQ TORIC ASTIGMATISM IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm BICONVEX TORICASPHERIC OPTIC, 3.75 D CYLINDER. · Class 3 · Implant
All models of ACRYSOF (353)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380652274395), received between Feb 25, 2026 and Feb 25, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Split, Cut or Torn1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 25, 2026Material Split, Cut or Torn
A REPORT WAS RECEIVED FROM NON-HEALTHCARE PROFESSIONAL VIA HEALTH AUTHORITY AND REPORTED THAT, THE PATIENT UNDERWENT RIGHT-EYE CATARACT SURGERY DUE TO AGE-RELATED MATURE CATARACT. DURING THE PROCEDURE, THE OPHTHALMIC SURGEON IMPLANTED AN INTRAOCULAR LENS (IOL) INTO THE CAPSULAR BAG AND FOUND THAT THE IMPLANTED IOL HAD ALREADY FRACTURED. THE FRACTURED IOL WAS IMMEDIATELY REMOVED. AFTER CONFIRMING THAT ALL FRAGMENTS OF THE FRACTURED LENS HAD BEEN COMPLETELY EXTRACTED, A BACKUP LENS OF THE SAME MODEL WAS IMPLANTED, AND THE SURGERY WAS COMPLETED. SURGICAL TIME WAS EXTENDED. THE DEFECTIVE IOL WAS RETAINED AND SENT TO THE MANUFACTURER FOR FURTHER INVESTIGATION. PRODUCT-RELATED CAUSES MAY BE THE INJECTOR TIP WAS OVERLY TIGHT, AND THE INTRAOCULAR LENS (IOL) MATERIAL WAS RELATIVELY SOFT. AS PER HEALTH AUTHORITY THIS CASE WAS CLASSIFIED AS SERIOUS INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24440420 ↗
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- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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