ACRYSOF® SN6AT5 (REF SN6AT5.235)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, 3.00 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652251068), received between Apr 19, 2021 and Feb 3, 2025 — classified as 2 injuries, 1 malfunction.
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
- Failure to Unfold or Unwrap1
Patient problems
- Eye Injury1
- Insufficient Information1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 3, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A NURSE REPORTED BEFORE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT THE HAPTIC WAS STUCK ON THE ANTERIOR OPTIC OF THE IOL. SURGEON HAD TO REMOVE HAPTIC FROM THE IOL OPTIC USING TWO UNSPECIFIED INSTRUMENTS. LENS WAS NOT EXPLANTED FROM THE PATIENT, AND IT WAS STILL IN THE EYES OF THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 21300882 ↗InjuryJun 20, 2023Defective Device; Defective Device
A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, 6 WEEKS POSTOPERATIVELY, THE PATIENT HAD UNEXPECTED REFRACTION OF +1.00/-5.00 160°. THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THE 5.235 LENS WAS EXCHANGED FOR A 6.235 LENS FOLLOWING THE INITIAL IMPLANT PROCEDURE . AS PER THE SURGEONS OPINION, FAULTY IOL THICKNESS AND CYLINDER INCORRECTLY FITTED IS THE CAUSE FOR THE UNEXPECTED REFRACTION. THE SYMPTOMS WERE RESOLVED TO THE PATIENT.
Patient problems: Visual Disturbances
MAUDE report 17164284 ↗InjuryApr 19, 2021Defective Device; Defective Device
A HEALTH CARE PROFESSIONAL REPORTED THAT A DEFECTIVE HAPTIC WAS FOUND DURING A CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION. THE LENS WAS REMOVED WITHOUT ENLARGEMENT OF INCISION. THE EXPLANTATION OF IOL PUT ADDITIONAL STRESS ON THE MAIN INCISION, LIKELY RESULTING IN INDUCED ASTIGMATISM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. MEDWATCH REFERENCE NUMBER: MW5098602
Patient problems: Eye Injury; Visual Impairment
MAUDE report 11690804 ↗
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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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