ACRYSOF® SN6AT5 (REF SN6AT5.250)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, 3.00 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652251099), received between Dec 14, 2021 and Aug 8, 2025 — classified as 2 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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
- Adverse Event Without Identified Device or Use Problem1
- Device Difficult to Setup or Prepare1
- Difficult to Advance1
- Material Deformation1
- Optical Decentration1
- Scratched Material1
Patient problems
- Insufficient Information3
- Visual Disturbances2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 8, 2025Device Difficult to Setup or Prepare; Scratched Material; Device Difficult to Setup or Prepare; Scratched Material
A HEALTH CARE PROFESSIONAL REPORTED THAT BEFORE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE AND DURING LOADING THE LENS WAS SCRATCHED AND DENTED. THERE WAS SIGNIFICANT RESISTANCE DURING INJECTION, AND THE SURGEON OBSERVED THAT THE METALLIC ARM OF THE INJECTOR HAD BEEN RESTING ON TOP OF THE LENS INSIDE THE CARTRIDGE. THE SURGEON EXAMINED THE LENS UNDER THE MICROSCOPE AFTER PUSHING THE IOL THROUGH THE CARTRIDGE AND DECIDED TO REUSE IT, EVEN THOUGH THE MARK WAS OFF AXIS. NO FURTHER INFORMATION EXPECTED AS REPORTER UNWILLING TO PROVIDE ADDITIONAL INFORMATION.
Patient problems: Insufficient Information
MAUDE report 22751338 ↗MalfunctionMay 24, 2022Difficult to Advance; Difficult to Advance
A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE LENS WOULD NOT DEPLOY. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 14487329 ↗InjuryFeb 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A OPHTHALMIC SURGEON REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED DOUBLE VISION AND ANISEIKONIA. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Visual Disturbances
MAUDE report 13547673 ↗MalfunctionJan 25, 2022Optical Decentration; Optical Decentration
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS EXPLANTED DUE TO MECHANICAL MALFUNCTION. ADDITIONAL INFORMATION WAS PROVIDED THAT THE PATIENT EXPERIENCED DIPLOPIA AND EXAMINATION SHOWED THE DISPLACED LENS. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE FOR DIFFERENT POWER LENS. THERE WAS NO PATIENT HARM. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Visual Disturbances
MAUDE report 13341712 ↗InjuryDec 14, 2021Material Deformation; Material Deformation
A PHARMACIST REPORTED DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS IMPLANT PROCEDURE, THERE WAS LOSS OF SUPPORT WITH DISRUPTION OF THE HAPTIC. IT HAD TO BE REPLACED FOR IMPLANT WITH SCLERAL FIXATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 13004327 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page