ACRYSOF® SN6AT3 (REF SN6AT3.120)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
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652249737), received between Apr 30, 2021 and Jan 2, 2023 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.
Most reported problems
Device problems
- Device Dislodged or Dislocated1
- Failure to Unfold or Unwrap1
- Scratched Material1
Patient problems
- Blurred Vision1
- Capsular Bag Tear1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 2, 2023Scratched Material; Scratched Material
A PURCHASING COORDINATOR REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SCRATCH WAS NOTICED ON THE LENS. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 16082901 ↗InjuryApr 8, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED DECREASED VISION. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 15 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION AS BEEN RECEIVED AND STATED THAT IN SURGEON'S OPINION PRODUCT DID NOT CONTRIBUTE TO THE EVENT DUE TO DISLOCATED IMPLANT DUE TO POSTERIOR CAPSULAR RENT. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT.
Patient problems: Blurred Vision; Capsular Bag Tear
MAUDE report 14050783 ↗MalfunctionApr 30, 2021Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS FOLDED AND DID NOT OPEN CORRECTLY. NO PATIENT IMPACT WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11752790 ↗
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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