ACRYSOF® SN6AT5 (REF SN6AT5.220)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
- 6
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652251037), received between Mar 25, 2021 and May 19, 2026 — classified as 4 injuries, 2 malfunctions.
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 Problem4
- Defective Device1
- Material Split, Cut or Torn1
Patient problems
- Blurred Vision2
- Insufficient Information2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Endophthalmitis1
- Vertigo1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 19, 2026Material Split, Cut or Torn
A PHARMACIST REPORTED THAT LENS HAD BEEN BROKEN AS THE LENS DID NOT COME LOOSE FROM INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE 2 OF 2 FILES.
Patient problems: Insufficient Information
MAUDE report 25216981 ↗InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD INTOLERANCE OF MONOVISION-VERTIGO. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS INTOLERANT OF MONOVISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Vertigo
MAUDE report 19310161 ↗InjuryFeb 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION. THE SURGEON DID RETINAL PEEL, AFTER THAT VISION WAS WORSEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 16442181 ↗InjuryFeb 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CUSTOMER REPORTED THAT A PATIENT EXPERIENCED ENDOPHTHALMITIS IN THE OPERATED EYE THAT WAS NOTED DURING THE POST-OPERATIVE CHECK-UP. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED. THIS IS THIRD PRODUCT REPORT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: Endophthalmitis
MAUDE report 13614217 ↗MalfunctionMay 10, 2021Defective Device; Defective Device
ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THE INITIAL REPORT DESCRIPTION WAS NOT CORRECT. THE CORRECT DESCRIPTION OF THE EVENT IS AN UNSPECIFIED ISSUE WITH THE LENS.
Patient problems: Insufficient Information
MAUDE report 11797010 ↗InjuryMar 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PATIENT EXPERIENCED BLURRY VISION AND IS DISSATISFIED WITH THE REFRACTIVE OUTCOME. THE LENS WAS REMOVED ON A SECONDARY SURGERY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision
MAUDE report 11568286 ↗
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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