ACRYSOF® SN6AT4 (REF SN6AT4.210)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, 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
- 11
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00380652250443), received between Dec 2, 2021 and Dec 19, 2025 — classified as 5 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other 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
- Device Contamination with Chemical or Other Material2
- Failure to Advance2
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Defective Device1
- Device Dislodged or Dislocated1
- Failure to Align1
Patient problems
- Visual Impairment6
- Blurred Vision4
- Insufficient Information4
- Dry Eye(s)1
- Visual Disturbances1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A PHYSICIAN REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE IOL ROTATED POST SURGERY CAUSING REFRACTIVE SURPRISE.
Patient problems: Visual Impairment
MAUDE report 23850410 ↗MalfunctionJan 30, 2025Product Quality Problem; Product Quality Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF DEFECTIVE INTRAOCULAR LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21273645 ↗InjuryApr 4, 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 EASON AS NOT ABLE TO SEE AS EXPECTED AND CLINICAL REASON FOR EXPLANT BEING PATIENT COULDN'T SEE WELL WITH LENS DESIGN, BETTER SUITED FOR UPGRADED LENS. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 19039813 ↗MalfunctionDec 20, 2023Break; Failure to Advance; Break; Failure to Advance
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS NOT DELIVERED COMPLETELY INTO THE ANTERIOR CHAMBER DUE TO RESISTANCE IN THE CARTRIDGE. IOL WAS GENTLY PULLED OUT FROM CARTRIDGE BUT TRAILING HAPTIC BROKE OFF. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18363368 ↗MalfunctionMar 10, 2023Failure to Advance; Defective Device; Failure to Advance; Defective Device
A NURSE REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THE LENS WAS RIGID AND STIFF AND DID NOT SLIDE FORWARD IN THE CARTRIDGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE SURGERY WAS COMPLETED WITH NO ISSUES.
Patient problems: Insufficient Information
MAUDE report 16519853 ↗InjuryFeb 24, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A NON-HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED DECREASED VISION. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS LENS GLISTENING. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 16436178 ↗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 RIGHT EYE.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 15751105 ↗InjuryAug 22, 2022Inaccurate Delivery; Inaccurate Delivery
A NURSE REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION. THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE AND THE CLINICAL REASON FOR EXPLANT WAS FLIPPED AXIS WITH TORIC LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED WHICH STATES THERE WAS NO PATIENT HARM.
Patient problems: Blurred Vision
MAUDE report 15269217 ↗MalfunctionJul 19, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON FOUND THAT IOL HAD LENS MATERIAL HANGING OFF THE EDGE OF THE IOL. THE MATERIAL WAS REMOVED BY SURGEON WITH FORCEPS. THE REMOVED PIECES WERE NOT SAVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15051748 ↗InjuryMar 25, 2022Failure to Align; Failure to Align
A PHYSICIAN REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED REFRACTIVE SURPRISE, FAINT SHADOW. SLIGHT FLUCTUATION UNCORRECTED VISUAL ACUITY ON POST OP VISITS DUE TO DRY EYE. PATIENT WAS TREATED WITH PLUGS AND MEDICATIONS, NO CHANGE IN SYMPTOMS. ONLINE CALCULATOR SHOWS ROTATION OF 14 DEGREES CCW TO 175. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Dry Eye(s); Visual Disturbances; Visual Impairment
MAUDE report 13903981 ↗InjuryDec 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION RECEIVED AND REPORTED THAT THE IOL WAS EXCHANGED FOR THE SAME LENS MODEL BUT ONE DIOPTER LESS POWER INDICATING THE CORRECT LENS POWER WAS NOT IMPLANTED INITIALLY. THERE IS NO REPORTED DEFECT OR FAULT WITH THE IOL.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 12917918 ↗
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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