ACRYSOF® SN6AT6 (REF SN6AT6.160)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, 3.75 D CYLINDER. · Class 3 · Implant
All models of ACRYSOF (353)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652274258), received between Oct 11, 2022 and Jul 25, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
- Device Dislodged or Dislocated1
- Scratched Material1
Patient problems
- Corneal Edema1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 25, 2024Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated
A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, UPON INSERTION ONE OF THE HAPTIC OF THE LENS WAS FOUND TO BE BROKEN. THE LENS WAS LEFT IMPLANTED. IT WAS FURTHER REPORTED THAT AFTER 2 WEEKS OF IMPLANTATION, THE IMPLANT TURNED AND NEED TO BE REMOVED AND INSERT ANOTHER ONE. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THE PATIENT EXPERIENCED TRANSIENT SLIGHT CORNEAL EDEMA AND THE LENS WAS EXCHANGED FOR SAME LENS MODEL 28 DAYS FOLLOWING THE INITIAL PROCEDURE. THERE WAS NO PATIENT CONSEQUENCES REPORTED AFTER REPLACEMENT.
Patient problems: Corneal Edema
MAUDE report 19828053 ↗MalfunctionOct 11, 2022Scratched Material; Scratched Material
A FACILITY REPRESENTATIVE REPORTED THAT, FOLLOWING INTRAOCULAR LENS IMPLANT PROCEDURE, IT WAS NOTICED THAT THE LENS HAD SCRATCH AFTER INSERTION, REMOVED AND REPLACED. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 15574644 ↗
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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