ACRYSOF® SN6AT5 (REF SN6AT5.200)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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652250993), received between Apr 1, 2021 and Apr 4, 2025 — classified as 2 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (2 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
- Adverse Event Without Identified Device or Use Problem2
- Scratched Material2
- Crack1
- Defective Device1
- Device Contamination with Chemical or Other Material1
Patient problems
- Insufficient Information4
- Blurred Vision2
- Foreign Body Sensation in Eye1
- No Clinical Signs, Symptoms or Conditions1
- Visual Impairment1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 4, 2025Scratched Material; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION, THE SURGEON NOTICED A SCRATCH ON THE LENS. THE SCRATCH WAS NOT SEEN BEFORE FOLDING AND WAS IN A LOCATION THAT WAS NOT TOUCHED DURING THE FOLDING PROCESS. THE LENS REMAINED IMPLANTED, AS THE SCRATCH WAS PERIPHERAL. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 1 OF 3. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21771892 ↗InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING BLURRED VISION AS REASON FOR EXPLANT.
Patient problems: Blurred Vision; Insufficient Information
MAUDE report 19613497 ↗MalfunctionAug 11, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SOME HARD DRIED MATERIAL AT THE POSTERIOR SURFACE OF THE INTRAOCULAR LENS. THE FOREIGN MATERIAL WAS ASPIRATED AWAY BUT LEAVING MINIMAL RESIDUE ON THE INTRAOCULAR LENS. NO MORE INFORMATION AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 15207975 ↗MalfunctionMar 16, 2022Defective Device; Defective Device
A PHARMACIST REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THE LENS WAS DEFECTIVE AND WAS BROKEN DURING REMOVAL. IT WAS NOT SPECIFIED WHAT THE DEFECT WAS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 13787294 ↗InjuryNov 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRINESS AND FELT LIKE CONTACT LENS IN EYE. THE IOL WAS EXCHANGED FOR A DIFFERENT LENS WITHIN 1 MONTH AFTER INITIAL IMPLANTATION DUE TO RESIDUAL REFRACTIVE ASTIGMATISM.
Patient problems: Blurred Vision; Foreign Body Sensation in Eye; Visual Impairment
MAUDE report 12827720 ↗MalfunctionApr 1, 2021Crack; Scratched Material; Crack; Scratched Material
CORRECTED INFORMATION: THE INTRAOCULAR LENS WAS CRACKED, AFTER UNFOLDING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11605715 ↗
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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