ACRYSOF® SN6AT3 (REF SN6AT3.260)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, 1.50 D CYLINDER. · Class 3 · Implant
All models of ACRYSOF (353)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652250016), received between Dec 29, 2021 and Dec 12, 2025 — classified as 4 injuries, 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (2 reports).
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 Deformation2
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Material Split, Cut or Torn1
Patient problems
- Insufficient Information2
- Visual Impairment2
- Capsular Bag Tear1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryDec 12, 2025Material Deformation; Material Deformation
A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT DEVELOPED POSTOPERATIVE GLISTENINGS. PATIENT PRESENTED TO THE CLINIC FOR YAG (YTTRIUM ALUMINUM GARNET) CAPSULOTOMY. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23789076 ↗InjuryNov 12, 2025Material Deformation; Material Deformation
A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT DEVELOPED POSTOPERATIVE GLISTENINGS. PATIENT PRESENTED TO THE CLINIC FOR YAG (YTTRIUM ALUMINUM GARNET) CAPSULOTOMY. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23530569 ↗MalfunctionMay 23, 2022Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE HAPTIC-OPTIC JUNCTION HAD A SPLIT IN THE LENS. THE LENS WAS REMOVED AND SECONDARY LENS IMPLANTED. NO SAMPLE AVAILABLE DUE TO LENS BEING DESTROYED ONCE REMOVED. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING NO PATIENT HARM, FIRST LENS WAS REMOVED WITH NO ISSUES AND NEW LENS INSERTED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14468305 ↗InjuryFeb 14, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A PATIENT WHO IS ALSO A PHYSICIAN REPORTED THAT, FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS EXPERIENCING, 'CROSS-HAIR' GLARE AROUND POINTS OF LIGHT, LENS WITH GLISTENING. A CORNEAL TREATMENT WAS PERFORMED BUT THAT HAS NOT CHANGED GLARE. RETINAL EVALUATION REVEAL NO PATHOLOGY, ALSO NO IMPROVEMENT WITH YTTRIUM ALUMINUM GARNET (YAG). ADDITIONAL INFORMATION WAS RECEIVED THAT, THE LEFT EYE SEEMED TO HAVE A FILM OVER IT WITH DECREASED BRIGHTNESS. A "START-CROSS" GLARE NOTED WHILE LOOKING AT POINT SOURCES OF LIGHT AND NOTED THAT IT WAS SIMILAR TO A PHOTOGRAPHY FILTER HE HAD USED IN THE PAST. NO ABNORMALITIES ON THE LENS SURFACE WERE NOTED. LENS EXCHANGE WAS REFERRED NOTING INCREASED RISK OF SURGERY DUE TO OPEN POSTERIOR CAPSULE.
Patient problems: Capsular Bag Tear; Visual Impairment
MAUDE report 13521171 ↗InjuryDec 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS DISSATISFIED WITH VISION CORRECTION. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 13107526 ↗
Other intraocular lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- 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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