ACRYSOF® SN6AT4 (REF SN6AT4.195)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
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652250412), received between Apr 3, 2024 and Apr 18, 2025 — classified as 2 injuries, 3 malfunctions.
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
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Defective Device1
- Failure to Deliver1
- Material Discolored1
Patient problems
- Insufficient Information3
- Blurred Vision1
- Posterior Capsule Opacification1
- Retinal Detachment1
- Visual Disturbances1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 18, 2025Failure to Deliver; Failure to Deliver
A PHARMACIST REPORTED THAT LENS FOUND TO BE BLOCKED. THE SECOND LENS WAS USED IN THE PATIENT AND DID NOT EXPERIENCE ANY DISCOMFORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION RECEIVED.
Patient problems: Insufficient Information
MAUDE report 21866072 ↗InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CONSUMER REPORTED ABOUT A COMPANY LENS TRANSPLANT DONE SEVERAL YEARS AGO. DURING FOLLOW-UP EXAM, WAS IN A LOT OF PAIN DURING THE SURGERY. THE DR. STATED HE HAD PROBLEMS DURING SURGERY. WHEN HE INSTALLED THE LENS IT WENT IN UPSIDE DOWN AND THEY HAD TO CUT IT OUT AND PUT ANOTHER ONE IN. THE PROBLEM WAS DURING AN EYE EXAM ( DIFFERENT DRS.) BOTH EYES WERE 20/20, BUT THE COMPANY LENS IMPLANTED EYE SEES THINGS CLOSER AND A LITTLE LOWER THAN THE EYE WITH A STANDARD LENS CONSUMER REPORTED A VISION DEPTH PROBLEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 20322977 ↗InjurySep 13, 2024Material Discolored; Material Discolored
A OTHER HEALTH CARE PROFESSIONAL REPORTED THAT AFTER SURGERY, THE PATIENT EXPERIENCED SEVERE POSTERIOR CAPSULAR OPACIFICATION AND HAD A YAG LASER TREATMENT BEFORE TO REMOVE PCO. PATIENT HAS DEVELOPED CANCER AND IS ALSO NOW ON CANCER TREATMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO RIGHT EYE. ADDITIONAL INFORMATION HAS RECEIVED IT STATES THAT THE PATIENT¿S VISION WAS GOOD, CORRECTED TO 1.2 IN RIGHT EYE. IN 2017, NOTICED THE GRADUAL ONSET SYMPTOMS OF PCO. AFTER YAG LASER TREATMENT, VISION WAS IMPROVED FROM 0.4 TO 1.0 IN THE RIGHT EYE, VISION CLEARED UP AND WAS GOOD. IN 2019 DURING EXAMINATION OF PCO RECURRENCE THEY NOTICED SLIGHT YELLOWING OF IOL, POSSIBLE OPACIFICATION STARTING. IN 2022, ALSO HAD A SAME FINDING. SO, THEY HAVE PLANNED A SURGERY FOR THE PATIENT.
Patient problems: Posterior Capsule Opacification; Retinal Detachment
MAUDE report 20213120 ↗MalfunctionMay 20, 2024Defective Device; Defective Device
A HEALTH CARE PROFESSIONAL REPORTED THAT THEY NOTICED THAT LENS WERE DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19353118 ↗MalfunctionApr 3, 2024Break; Break
A HEALTH CARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS BROKEN WHEN INJECTED IN PATIENT EYE. THE LENS HAD TO CUT TO REMOVE IT FROM THE PATIENT¿S EYE DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19030819 ↗
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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