ACRYSOF® SN6AT4 (REF SN6AT4.235)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, 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
- 14
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00380652250498), received between Mar 25, 2021 and Aug 28, 2025 — classified as 2 injuries, 12 malfunctions.
The most frequently reported specific device problem is “Defective Device” (3 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 Device3
- Break2
- Scratched Material2
- Adverse Event Without Identified Device or Use Problem1
- Crack1
- Device Contamination with Chemical or Other Material1
- Device Dislodged or Dislocated1
- Ejection Problem1
Patient problems
- Insufficient Information8
- No Clinical Signs, Symptoms or Conditions4
- Blurred Vision1
- Capsular Bag Tear1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 28, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, CRACK WAS NOTICED ON LENS DURING INSERTION SLIGHTLY OFF CENTER AND SMALL. THE SURGERY COMPLETED WITH SAME LENS. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE SURGEON THINKS EVENT COULD HAVE ALSO OCCURRED BY THE WAY SHE LOADED THE LENS AS SHE WAS STILL A REGISTRAR, AND THE OTHER SURGEON WAS NOT PRESENT AT THE TIME. THE LENS REMAINS IMPLANTED IN PATIENT'S EYE.
Patient problems: Insufficient Information
MAUDE report 22912151 ↗MalfunctionApr 25, 2025Break; Break
A PHARMACIST REPORTED THAT THE IMPLANTS DID NOT HAVE HAPTICS AND THERE WAS NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED AND IT STATES THAT THE DEFECT IDENTIFIED DURING INTRAOPERATIVE SURGERY. DURING IMPLANT PREPARATION PRIOR TO INTRAOCULAR INJECTION NOTICED THAT BACK HAPTICS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21907018 ↗MalfunctionApr 21, 2025Break; Break
A PHARMACIST REPORTED THAT THE IMPLANTS DID NOT HAVE HAPTICS AND THERE WAS NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS RECEIVED AND IT STATES THAT THE DEFECT IDENTIFIED DURING INTRAOPERATIVE SURGERY. DURING IMPLANT PREPARATION PRIOR TO INTRAOCULAR INJECTION NOTICED THAT BACK HAPTICS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21872801 ↗MalfunctionJun 26, 2023Crack; Crack
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION THAT , CARTRIDGE WAS CRACKED. THERE WAS PATIENT CONTACT WITH THE PRODUCT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17197488 ↗MalfunctionJan 17, 2023Defective Device; Defective Device
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS FOUND THAT, IOL WAS DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16183202 ↗MalfunctionJan 15, 2023Defective Device; Defective Device
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT A LENS WAS DEFECTIVE.
Patient problems: Insufficient Information
MAUDE report 16171583 ↗InjuryDec 7, 2022Problem with Sterilization; Adverse Event Without Identified Device or Use Problem; Problem with Sterilization; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAD POSTERIOR CAPSULAR RUPTURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Capsular Bag Tear
MAUDE report 15932756 ↗MalfunctionNov 22, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
A NON-HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE LENS WAS SHIFTED IN THE EYE. THE VISION AFTER THE SURGERY WAS NOT AS GOOD. THE PATIENT WOULD EITHER NEED GLASSES OR A PIGGYBACK IMPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 15842690 ↗MalfunctionOct 12, 2022Scratched Material; Scratched Material
A PHYSICIAN REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE OPTIC OF LENS WAS SCRATCHED. THE IOL WAS REPLACED WITH THE OTHER LENS. THE EVENT HAS BEEN RESOLVED. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 15586145 ↗MalfunctionAug 3, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
A HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, SCRATCH WAS OBSERVED ON THE IOL INSIDE THE EYE AND DECIDED TO EXPLANT THE IOL AND USE THE BACKUP IOL. BACKUP IOL WAS IMPLANTED AND THE SURGEON IS COMPLAINING THAT THE BACKUP IOL HAD ON THE SURFACE SOME "REST" OF AN UNKNOWN MATERIAL. HE CLEANED THE SURFACE, AND IT LOOKS FINE.
Patient problems: Insufficient Information
MAUDE report 15154683 ↗MalfunctionAug 3, 2022Scratched Material; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, SCRATCH WAS OBSERVED ON THE IOL INSIDE THE EYE AND DECIDED TO EXPLANT THE IOL AND USE THE BACKUP IOL. BACKUP IOL WAS IMPLANTED AND THE SURGEON IS COMPLAINING THAT THE BACKUP IOL HAD ON THE SURFACE SOME "REST" OF AN UNKNOWN MATERIAL. HE CLEANED THE SURFACE, AND IT LOOKS FINE.
Patient problems: Insufficient Information
MAUDE report 15154682 ↗InjuryNov 7, 2021Packaging Problem; Packaging Problem
THE UNSTERILE/PACKAGING ISSUE WAS NOTICED, BEFORE SURGERY. INDICATING, NO PATIENT CONTACT WITH THE PRODUCT. THE SURGERY WAS POSTPONED AND COMPLETED ON ANOTHER DATE AFTER PERFORMING PHACO. SINCE THE DEFECT WAS NOTED, BEFORE SURGERY, THERE IS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12764088 ↗MalfunctionSep 14, 2021Ejection Problem; Ejection Problem
A NURSE UNIT MANAGER REPORTED THAT THE LENS WAS EARLY OUT OF THE CARTRIDGE AT THE LEVEL OF THE MAIN INCISION WITH PATIENT CONTACT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12470755 ↗MalfunctionMar 25, 2021Defective Device; Defective Device
A CUSTOMER REPORTED A DEFECTIVE INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 11569000 ↗
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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