ACRYSOF® SN6AT4 (REF SN6AT4.220)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, 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
- 13
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00380652250467), received between Jul 13, 2021 and Sep 15, 2025 — classified as 6 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Failure to Deliver” (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 Problem5
- Failure to Deliver2
- Scratched Material2
- Application Program Problem: Power Calculation Error1
- Crack1
- Defective Device1
- Unintended Ejection1
Patient problems
- Insufficient Information7
- Visual Impairment2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Blurred Vision1
- Capsular Bag Tear1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2025Failure to Deliver; Failure to Deliver
A NON HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS WAS FAULTY AND DID NOT DEPLOY. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23052959 ↗MalfunctionJul 16, 2025Failure to Deliver; Failure to Deliver
A HEALTH CARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THAT LENS COULD NOT BE PLACED BECAUSE IT WAS STUCK. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE LENS WAS STUCK IN THE OPENING OF THE MAIN PORT. THE SURGERY WAS COMPLETED ON THE SAME DAY USING A BACKUP IOL. THERE WAS PATIENT CONTACT.
Patient problems: Insufficient Information
MAUDE report 22520158 ↗InjuryFeb 10, 2025Adverse 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 POOR VISION. CLINICAL REASON FOR EXPLANT DIFFERENT VISION REQUIRED. THE IOL WAS EXCHANGED FOR ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) MODEL LENS 1 MONTHS 19 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 21343571 ↗InjuryFeb 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, A TEAR WAS NOTICED AT THE POSTERIOR CAPSULE AFTER THE LENS IMPLANTATION. HENCE THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS IN THE SAME PROCEDURE AND AN ANTERIOR VITRECTOMY WAS PERFORMED AND THE NEW REPLACEMENT LENS WAS PLACED IN THE SULCUS RATHER THAN AS PER THE PLANNED LENS. THE PROCEDURE WAS EXTENDED TO APPROXIMATELY 20 TO 25 MINS. THERE WAS NO PATIENT HARM. THE PATIENT IS EXPECTED TO HAVE MORE POST OPERATIVE ASTIGMATISM THAN PLANNED.
Patient problems: Capsular Bag Tear
MAUDE report 18738949 ↗MalfunctionJan 24, 2024Defective Device; Defective Device
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF DEFECTIVE INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18572055 ↗InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED REFRACTIVE ERROR. THE LENS WAS EXPLANTED AND REPLACED WITH OTHER LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Visual Impairment
MAUDE report 17556177 ↗MalfunctionJul 6, 2023Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS FOUND TO HAVE SCRATCH. THE IOL WAS REMOVED DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17265000 ↗MalfunctionJan 18, 2023Crack; Crack
A PHYSICIAN REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE IOL HAD CRACK AFTER IMPLANTED IN EYE. THE IOL WAS EXPLANTED AND CHANGED A NEW ONE IMPLANTED. NO EFFECT ON THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16193929 ↗MalfunctionSep 8, 2022Unintended Ejection; Unintended Ejection
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS IMPLANT PROCEDURE, THE LENS JUMPED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15377327 ↗InjuryMay 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPORTED THAT, FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS HAVING PERSISTENT BLURRY VISION. THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Blurred Vision
MAUDE report 14523206 ↗MalfunctionMay 23, 2022Scratched Material; Scratched Material
THE PHYSICIAN REPORTED DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE. A SCRATCH WAS FOUND ON THE LENS ON THE POSTERIOR FACE, COMPROMISING THE CENTER OF THE OPTIC. THE LENS REMAINED IN THE EYE SINCE IT WAS NOT COMPROMISING THE VISUAL AXIS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 14469995 ↗InjuryMay 5, 2022Application Program Problem: Power Calculation Error; Application Program Problem: Power Calculation Error
A PHYSICIAN REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE CALCULATION OF THE LENS WAS FOUND OUT TO BE CALCULATED IN AN ERRONEOUS WAY. THE SURGEON PERFORMED A SECONDARY SURGERY TO ROTATE THE LENS, BUT THE HAPTIC WAS STUCK VERY STRONG AND THE SURGEON WAS NOT ABLE TO PULL OUT THE LENS. IT WAS DISCUSSED WITH THE PATIENT BUT THE PATIENT DECIDED THAT SHE WOULD PREFERRED AN EXTERNAL AID TO CORRECT THE RESIDUAL ASTIGMATISM (THE ONE SHE HAD BEEN USING BEFORE SURGERY: TORIC CONTACT LENSES) AND SINCE IT WAS RESOLVED. THE PATIENT WAS SATISFIED WITH A TORIC CONTACT LENS AFTER THE SURGERY OF THE 1ST EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 14285430 ↗InjuryJul 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED AN EXPLANTED IOL WITH REASON " MYOPIC OUTCOME." CLINICAL REASON " REFRACTIVE MISS".
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12160054 ↗
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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