ACRYSOF® SN6AT3 (REF SN6AT3.175)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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652249843), received between May 25, 2021 and Apr 12, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Defective Device” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Defective Device2
- Scratched Material2
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions2
- Corneal Endothelial Cell Loss1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 12, 2024Scratched Material; Scratched Material
A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, THE SURGEON NOTICED A DEFECT TO THE OPTIC - A SMALL CRATER IN THE ANTERIOR SURFACE OF THE IOL. THE IOL WAS LEFT IN PLACE BECAUSE PATIENT HAD HISTORY OF FUCHS AND SMALL PUPIL AT BASELINE. NEXT DAY THE PATIENT HAD VISUAL ACUITY SCORE OF 20/30, BUT THE DEFECT WAS UNCHANGED, LOCATED AT IRIS MARGIN EVEN AFTER DILATING DROPS. THE PATIENT WAS HAPPY. THE SURGEON COULD ALSO SEE THE GUTTATA IN PATIENT'S EYE. ACCORDING TO ADDITIONAL INFORMATION RECEIVED, THE DEFECT WAS PERIPHERAL AND NOT VISUALLY-SIGNIFICANT. THE PROGNOSIS WAS EXCELLENT WITH REGARDS TO THE IOL. THE PATIENT HAD FUCHS CORNEAL DYSTROPHY, WHICH LIMITED HIS BEST CORRECTED VISUAL ACUITY (BCVA) AND MIGHT PROGRESS. THIS WAS NOT IMPACTED BY THE LENS DEFECT.
Patient problems: Corneal Endothelial Cell Loss; Insufficient Information
MAUDE report 19097342 ↗MalfunctionMar 13, 2023Defective Device; Defective Device
A OTHER HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF DEFECTIVE INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16527962 ↗MalfunctionJun 9, 2021Scratched Material; Scratched Material
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT PATIENT ISSUE WAS RESOLVED WITH NO HOSPITALIZATION AND HARM TO THE PATIENT. THE PROGNOSIS WAS ALSO GOOD.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11968636 ↗MalfunctionMay 25, 2021Defective Device; Defective Device
A FACILITY REPRESENTATIVE REPORTED OF AN INTRAOCULAR LENS (IOL) WAS DAMAGED. THERE WAS NO INFORMATION RELATED TO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11878146 ↗
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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