ACRYSOF® SN6AT4 (REF SN6AT4.165)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
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652250351), received between Sep 26, 2022 and Nov 28, 2023 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Defective Device” (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 Problem1
- Appropriate Device Problem Term/Code Not Available1
- Defective Device1
- Device Dislodged or Dislocated1
Patient problems
- Blurred Vision2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Insufficient Information1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryNov 28, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD BLURRED VISION. THE IOL WAS EXCHANGED FOR ANOTHER MODEL COMPANY LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS LENS ROTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 18214112 ↗InjuryMar 3, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A NON HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE DUE TO SEEING REFLECTIONS AND SUBSURFACE GLISTENINGS AND NANO GLISTENINGS. THERE WAS NO HARM TO THE PATIENT NOR THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE PROGNOSIS WAS GOOD AND THE PATIENT ISSUES HAVE RESOLVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Disturbances
MAUDE report 16476176 ↗MalfunctionFeb 17, 2023Defective Device; Defective Device
A PHARMACIST REPORTED AS IOL WAS DEFECTIVE NOTED DURING THE POSE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 16394301 ↗InjurySep 26, 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. PATIENT FELT VISION WAS WORSE THAN BEFORE SURGERY. DOCTOR FOUND PATIENT TO HAVE RESIDUAL REFRACTIVE ERROR WITH POSTERIOR CAPSULAR HAZE. IT WAS REPORTED THAT IRIS REPAIR WAS PERFORMED AND THE LENS WAS EXPLAINED. THE LENS WAS REPLACED WITH NON-COMPANY PRODUCT. THERE WAS NO PATIENT HARM AND PATIENT WAS NOT HOSPITALIZED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Visual Impairment
MAUDE report 15485868 ↗
Other intraocular lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- 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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