AcrySof Toric Aspheric UV Absorbing IOL SA6AT3 (REF SA6AT3.205)Recalls & reported problems
Alcon Laboratories, Inc. · The AcrySof Aspheric UV Absorbing Toric Posterior Chamber Intraocular Lens (IOL) is a UV Absorbing foldable intraocular lens (IOL) · Class 3 · Implant
All models of AcrySof Toric Aspheric UV Absorbing IOL (56)
Data updated Oct 18, 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 00380652335775), received between Oct 21, 2022 and Aug 28, 2024 — classified as 2 injuries, 3 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Scratched Material2
- Defective Device1
Patient problems
- Blurred Vision2
- Insufficient Information2
- Visual Impairment2
- Halo1
- Visual Disturbances1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 28, 2024Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, A SCRATCH WAS NOTICED ON THE IOL AFTER IT WAS INSERTED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 20083593 ↗MalfunctionMay 3, 2023Defective Device; Defective Device
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT A LENS WAS WASTED DUE TO MALFORMATION. ADDITIONAL INFORMATION AS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16863329 ↗InjuryFeb 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT VISION UNCHANGED. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS DIFFICULTY NIGHT DRIVING, GLARE, HALO ISSUES AND DEPTH PERCEPTION . ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: Halo; Visual Disturbances; Visual Impairment
MAUDE report 16363825 ↗MalfunctionOct 29, 2022Scratched Material; Scratched Material
AN ADMINISTRATOR REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED STAR BURSTS AND VISUAL DISTURBANCES. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS THERE WAS A SCRATCH ON THE INTRAOCULAR LENS THAT WAS AFFECTING PATIENT VISION. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 15697163 ↗InjuryOct 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING IMPLANTATION OF INTRAOCULAR LENS, THE PATIENT EXPERIENCED DECREASED VISION. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND EXCHANGED WITH ANOTHER MODEL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 15651062 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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