ACRYSOF® SN6AT5 (REF SN6AT5.210)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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652251013), received between Dec 31, 2021 and Mar 5, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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
- Device Contamination with Chemical or Other Material1
- Device Damaged by Another Device1
- Failure to Advance1
- Scratched Material1
Patient problems
- Blurred Vision1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Visual Impairment1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2024Failure to Advance; Device Damaged by Another Device; Failure to Advance; Device Damaged by Another Device
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, LENS WAS SITTING CORRECTLY AND WHEN SURGEON STARTED INSERTING CARTRIDGE INTO PATIENT'S EYE PLUNGER WENT OVER THE LENS AND STARTED TO WRAP AROUND INJECTOR AND WOULD NOT EJECT INTO THE PATIENT'S EYE AND DUE TO THIS HAPTIC BROKE OFF. PROCEDURE WAS COMPLETED WITH NEW LENS WITH NO HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18835258 ↗MalfunctionNov 8, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WERE LEFT OVER FRAGMENTS IN THE EYE THAT HAD TO BE REMOVED DURING THE CASE AND PATIENT EXPERIENCED BLURRY VISION AT ALL DISTANCES. PATIENT ALSO STATED HE HAS DRY AMD (AGE-RELATED MACULAR DEGENERATION) THAT IS SLOW PROGRESSIVELY AND IS NOT IMPACTING HIS VISION ACCORDING TO HIS DOCTORS. HE IS ALSO EXPERIENCING ASTIGMATISM. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 15751169 ↗MalfunctionDec 31, 2021Scratched Material; Scratched Material
A GENERAL MANAGER REPORTED THAT, LINE ACROSS THE IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 13125489 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page