ACRYSOF® SN6AT4 (REF SN6AT4.225)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00380652250474), received between Mar 22, 2021 and Nov 7, 2025 — classified as 4 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2025Material Deformation; Material Deformation

  A NON-HEALTHCARE PROFESSIONAL REPORTED VIA THE CHINESE HEALTH AUTHORITY THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS DAMAGED WHEN INSERTING INTO THE INJECTOR AFTER IT WAS OPENED. THE IOL WAS REPLACED WITH A NEW ONE.

  Patient problems: Insufficient Information

  MAUDE report 23503706 ↗
• MalfunctionAug 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ADDITIONAL INFORMATION WAS RECEIVED. THERE WAS NO PATIENT HARM AND THE SURGERY WAS COMPLETED ON THE SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22772510 ↗
• MalfunctionFeb 26, 2025Product Quality Problem; Product Quality Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT, WHEN TRYING TO CLEAN UP THE CONSIGNMENT COME ACROSS A FACILITY WHO HAS A FEW MISSING LENSES. LATER CONFIRMED THAT THE LENSES WERE FAULTY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS FILE IS 1 OF 2

  Patient problems: Insufficient Information

  MAUDE report 21466029 ↗
• MalfunctionFeb 24, 2025Product Quality Problem; Product Quality Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, (B)(6) WAS TRYING TO CLEAN UP THE CONSIGNMENT AND COME ACROSS A FACILITY WHO HAS A FEW MISSING LENSES. LATER (B)(6) SENT INFORMATION THAT THE LENSES WERE FAULTY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS FILE IS 2 OF 2.

  Patient problems: Insufficient Information

  MAUDE report 21446793 ↗
• InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED NAUSEA AND TRAPEZOID VISION ONLY UP CLOSE AND INTERMEDIATE. WHEN THE PATIENT COVER EACH EYE INDEPENDENTLY THE TRAPEZOID FLIPS. THE PATIENT VISION WAS GOOD BUT CLOSE VISION WAS DIFFICULT, CONSTANT NAUSEA AT NEAR, THE EYES KEEP CHANGING, THE PATIENT HAS DRY EYE, LIFITEGRAST X 16 WEEKS WAS GIVEN FOR DRY EYES. THE POSSIBLE DRY EYE TREATMENT HAS BEEN TOLD POSSIBLE STRABISMUS ISSUE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT AFTER CATARACT SURGERIES IN EARLY (B)(6) 2024, THE PATIENT BEGAN EXPERIENCING TRAPEZOIDAL DISTORTIONS, WITH OBJECTS APPEARING WIDER AT THE BOTTOM WHEN BOTH EYES ARE OPEN AND FLIPPING DEPENDING ON THE EYE USED. SOON AFTER, EXTREME NAUSEA, DIZZINESS, HEADACHES, EYE STRAIN, AND FATIGUE DEVELOPED, ESPECIALLY WITH NEAR TASKS LIKE READING, TYPING, OR LOOKING AT SCREENS. THESE SYMPTOMS, SIMILAR TO WHAT THEY EXPERIENCED IN THE PAST WITH AN OVERLY STRONG GLASSES PRESCRIPTION, DID NOT IMPROVE WITH ANY OF THE SIX DIFFERENT GLASSES OR CONTACT LENS PRES

  Patient problems: Blurred Vision; Dizziness; Dry Eye(s); Eye Irritation; Headache; Nausea; Visual Disturbances; Visual Impairment

  MAUDE report 20638570 ↗
• MalfunctionApr 1, 2024Failure to Eject; Failure to Eject

  A PHARMACIST REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS WAS STUCK IN THE CARTRIDGE. THE BACKUP LENS WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19011509 ↗
• InjuryDec 6, 2023Defective Component; Defective Component

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT BACK IN FOR A REPOSITION OF THE IOL 3 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE AND SURGEON NOTICED THE HAPTIC WAS DEFECTIVE AND BROKEN IN THE EYE. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18272947 ↗
• MalfunctionApr 20, 2023Defective Device; Defective Device

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT A LENS WAS DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE DAMAGE TO THE LENS WAS OBSERVED UPON OPENING. THE SURGERY WAS COMPLETED BY USING ANOTHER BACK UP LENS.

  Patient problems: Insufficient Information

  MAUDE report 16776041 ↗
• InjuryJul 20, 2022Application Program Problem: Power Calculation Error; Application Program Problem: Power Calculation Error

  A PHYSICIAN REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT CANT SEE, WRONG POWER LENS IMPLANTED. THE LENS WAS LATER EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 15062983 ↗
• MalfunctionSep 8, 2021Failure to Eject; Failure to Eject

  A NURSE UNIT MANAGER REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE LENS WAS STUCK IN CARTRIDGE WITH PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12437395 ↗
• InjuryMar 22, 2021Defective Device; Scratched Material; Defective Device; Scratched Material

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING DIFFICULTIES WITH PLACING THE LENS IN THE CARTRIDGE CORRECTLY, THE LENS WAS FOUND TO BE SCRATCHED FOLLOWING INSERTION IN THE EYE. THE INCISION SIZE WAS INCREASED AND THE LENS WAS REMOVED. THE IRIS HERNIATED AND A PARTIAL IRIDECTOMY WAS PERFORMED. THE IOL WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THE FOLLOWING DAY THE PATIENT'S INTRAOCULAR PRESSURE WAS HIGH. FURTHER INFORMATION HAS NOT BEEN RECEIVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Intraocular Pressure Increased; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11541520 ↗