ACRYSOF® SN6AT3 (REF SN6AT3.085)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
- 6
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652249669), received between Apr 30, 2021 and May 29, 2023 — classified as 1 injury, 5 malfunctions.
The most frequently reported specific device problem is “Crack” (3 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.
Most reported problems
Device problems
- Crack3
- Adverse Event Without Identified Device or Use Problem1
- Defective Device1
- Scratched Material1
Patient problems
- Insufficient Information4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Visual Impairment1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 29, 2023Crack; Crack
A SURGEON REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTICED DIAGONAL CRACK/DAMAGE IN CENTRAL OPTIC.
Patient problems: Insufficient Information
MAUDE report 17016793 ↗MalfunctionMay 29, 2023Crack; Crack
A SURGEON REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTICED SMALL MORE PERIPHERAL DIAGONAL CRACK IN OPTIC , LENS ALREADY IMPLANTED AND THEN EXPLANTED.
Patient problems: Insufficient Information
MAUDE report 17016766 ↗MalfunctionMay 26, 2023Crack; Crack
A PHYSICIAN REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT, THERE WAS A DIAGONAL CRACK IN EXACT SAME SPOT ON LENS. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 17008962 ↗MalfunctionOct 11, 2022Scratched Material; Scratched Material
A PHYSICIAN REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DOCTOR NOTICED A SCRATCH RIGHT IN THE MIDDLE OF THE OPTIC AFTER IMPLANTING THE LENS. THIS RESULTED IN EXPLANTING THE LENS AND REPLACE IT WITH ANOTHER ONE DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15578396 ↗InjuryJun 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANTATION AFTER TWO MONTHS THE LENS WAS EXPLANTED DUE TO UNDESIRED REFRACTION OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED.
Patient problems: Visual Impairment
MAUDE report 11956683 ↗MalfunctionApr 30, 2021Defective Device; Defective Device
AN INTRAOCULAR LENS (IOL) REPLY CARD WAS RECEIVED FROM A CUSTOMER STATING THAT DURING AN IOL IMPLANT PROCEDURE, THE LENS WAS ILL-FORMED AND REMOVED DURING THE INITIAL PROCEDURE. THERE WAS PATIENT CONTACT BUT NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11752196 ↗
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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