ACRYSOF® SN6AT4 (REF SN6AT4.180)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, 2.25 D CYLINDER. · Class 3 · Implant
All models of ACRYSOF (353)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652250382), received between Nov 8, 2021 and May 26, 2025 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 Problem2
- Appropriate Device Problem Term/Code Not Available1
- Material Split, Cut or Torn1
- Scratched Material1
Patient problems
- Insufficient Information2
- Visual Impairment2
- Blurred Vision1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 26, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT LENS FOUND TO BE BROKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION RECEIVED.
Patient problems: Insufficient Information
MAUDE report 22084946 ↗InjuryOct 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION AND THE CLINICAL REASON WAS IRREGULAR ASTIGMATISM INDUCED BY LENS. THE LENS WAS LATER EXCHANGED WITH A MONOFOCAL LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 15560983 ↗MalfunctionMar 12, 2022Scratched Material; Appropriate Device Problem Term/Code Not Available; Scratched Material; Appropriate Device Problem Term/Code Not Available
A NON-HEALTH PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, SCRATCH ON LENS NOTED AFTER IT WAS IMPLANTED. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, IN THE SURGEON OPINION IMPROPER LOADING OF THE LENS BY THE SCRUB TECH WAS THE CAUSE OF THE INCIDENT.
Patient problems: Insufficient Information
MAUDE report 13749344 ↗InjuryNov 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTH PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION. THE IOL EXCHANGED FOR ANOTHER LENS THIRTY SEVEN DAYS FOLLOWING THE INITIAL PROCEDURE FOR CLINICAL REASON OF INCORRECT POWER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 12769068 ↗
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- 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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