ACRYSOF® SN6AT3 (REF SN6AT3.225)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
- 9
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00380652249942), received between Oct 26, 2021 and May 19, 2026 — classified as 3 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (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
- Adverse Event Without Identified Device or Use Problem2
- Scratched Material2
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Failure to Eject1
- Material Split, Cut or Torn1
- Material Twisted/Bent1
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Adhesion(s)1
- Blurred Vision1
- Corneal Clouding/Hazing1
- Visual Disturbances1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 19, 2026Material Split, Cut or Torn
A PHARMACIST REPORTED THAT LENS HAD BEEN BROKEN AS THE LENS DID NOT COME LOOSE FROM INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE 1 OF 2 FILES.
Patient problems: Insufficient Information
MAUDE report 25216979 ↗MalfunctionNov 21, 2025Scratched Material; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF MARK ON LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23619445 ↗MalfunctionMay 27, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY THE PATIENT UNDERWENT PHACOEMULSIFICATION OF CATARACT AND IOL (INTRAOCULAR LENS) IMPLANTATION IN THE RIGHT EYE UNDER LOCAL ANESTHESIA. AFTER OPENING THE PACKAGING OF THE IOL AND PREPARING FOR ITS IMPLANTATION, IT WAS DISCOVERED THAT ONE OF THE HAPTICS OF THE IOL WAS BROKEN, RENDERING IT UNIMPLANTABLE. SO, THE SURGERY WAS COMPLETED ON THE SAME DAY BY USING ANOTHER MODEL LENS WITH SAME POWER. THE PATIENT RECOVERED WELL AFTER THE SURGERY AND HAD NO DISCOMFORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22085945 ↗InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTH CARE PROFESSIONAL REPORTED THAT AFTER SURGERY, THE PATIENT EXPERIENCED BLURRY VISION WHEN READING. CLINICAL REASON BEING MENTIONED AS IOL (INTRAOCULAR LENS) MALFUNCTION. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN MONOFOCAL LENS FOLLOWING THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 20641470 ↗MalfunctionFeb 9, 2024Material Twisted/Bent; Material Twisted/Bent
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, REPORTED WITH A DESCRIPTION OF THAT LENS WAS BEING INSERTED, WHEN NOTICED A BEND IN LENS UNDER MICROSCOPE, SO TOOK LENS OUT DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 18674722 ↗InjuryNov 1, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ADDITIONAL INFORMATION HAS BEEN RECEIVED FROM THE SURGEON AND STATED THAT, THE PATIENT HAD VITRECTOMY (AS PER THE PATIENT). THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE.
Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Corneal Clouding/Hazing; Visual Disturbances
MAUDE report 18045927 ↗InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A DIRECTOR OF NURSING REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, PATIENT COMPLAINED OF INTOLERABLE LENS IMPLANT. THE IOL WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH ANOTHER LENS. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 16762612 ↗MalfunctionFeb 14, 2022Scratched Material; Scratched Material
A FACILITY REPRESENTATIVE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS NOTED SCRATCHED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13521247 ↗MalfunctionOct 26, 2021Failure to Eject; Failure to Eject
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS UNABLE TO INSERT. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12697924 ↗
Other intraocular lens devices
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- 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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