ACRYSOF® SN6AT3 (REF SN6AT3.220)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, 1.50 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 00380652249935), received between Jun 9, 2022 and Sep 3, 2024 — classified as 2 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Crack” (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
- Crack2
- Material Split, Cut or Torn2
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions2
- Blurred Vision1
- Endophthalmitis1
- Hypopyon1
- Inflammation1
- Loss of Vision1
- Visual Impairment1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 3, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, A HUGE SPLIT DOWN THE MIDDLE OF THE LENS WAS NOTICED UPON INSERTION. THE LENS HAD TO BE CUT OUT AND REMOVED IN AN INITIAL PROCEDURE AND A BACKUP LENS WAS PUT IN. ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED, THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20127348 ↗MalfunctionApr 23, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
A NON-HEALTH CARE PROFESSIONAL REPORTED WITH THE DESCRIPTION OF RADIAL BREAKAGE OF THE OPTICS AND THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19162748 ↗InjuryOct 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT PRESENTED WITH EXACERBATED INTRAOCULAR INFLAMMATION, WITH HYPOPIA THAT EVOLVED INTO ENDOPHTHALMITIS. THERE WAS ALSO ADDITIONAL MEDICAL INTERVENTION OR HOSPITALIZATION ASSOCIATED WITH THE EVENT. THERE WAS PATIENT HARM, BLINDNESS. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, THE BLINDNESS WAS IRREVERSIBLE, WITH NO RECOVERY, EVEN AFTER INTERVENTION AND TREATMENT.
Patient problems: Endophthalmitis; Hypopyon; Inflammation; Loss of Vision
MAUDE report 17886774 ↗MalfunctionMay 29, 2023Crack; Crack
A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTICED A LESS THAN 1 MM CRACK RIGHT AT THE EDGE, 1-2 MM AWAY FROM THE LEADING HAPTIC. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17016767 ↗InjuryMay 26, 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 DISTANCE VISION WAS NOT AS EXPECTED . THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 2 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON FOR EXPLANT MENTIONED AS INCORRECT LENS POWER.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 17008882 ↗MalfunctionJun 9, 2022Crack; Crack
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS OPTIC GOT CRACK. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 14641237 ↗
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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