ACRYSOF® SN6AT3 (REF SN6AT3.215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00380652249928), received between Mar 12, 2021 and Aug 1, 2025 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Defective Device” (4 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.

• MalfunctionAug 1, 2025Break; Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING IMPLANTATION OF INTRAOCULAR LENS (IOL) THE TRAILING HAPTIC WAS FOUND TO BE BROKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22688632 ↗
• MalfunctionFeb 26, 2025Break; Break

  A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF WHEN THE LENS USED, THE HAPTIC FRACTURED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING DURING PHACOERYSIS AND INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE IN RIGHT EYE, WHEN THE LENS USED, THE HAPTIC FRACTURED. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY IMPACT TO THE PATIENT. THE PATIENT WAS RECOVERED WITH SEQUELAE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING LENS WAS REPLACED BY ANOTHER WITH THE SAME CHARACTERISTICS WITHOUT PROBLEMS, SO IT WAS RESOLVED IN THE SAME SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21466033 ↗
• MalfunctionMar 15, 2024Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED WITH THE DESCRIPTION OF SCRATCHED INTRAOCULAR LENS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18912699 ↗
• InjuryDec 6, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT VISION WAS NOT CLEAR AND WORSENING. CLINICAL REASON WAS SUBLUXATED IOL. AN ATTEMPT WAS MADE TO REPOSITION BUT THE LENS WOULD NOT STAY IN PLACE. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 14 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 18272930 ↗
• MalfunctionJul 18, 2023Defective Device; Defective Device

  A NURSE REPORTED ABOUT A LENS DAMAGE DETECTED DURING INTRAOCULAR IMPLANTATION PROCEDURE. THE SURGERY WAS COMPLETED WITH AN ANOTHER LENS. NO FURTHER INFORMATION EXPECTED AS REPORTER UNWILLING TO PROVIDE ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 17342532 ↗
• MalfunctionSep 30, 2022Defective Device; Defective Device

  A NON HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF FAULTY INJECTOR AND EXPLANTED THE INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 15518730 ↗
• MalfunctionJul 28, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A CONSUMER REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A LINE GOING THROUGH THE IMPLANTED IOL. ADDITIONAL INFORMATION WAS RECEIVED STATING THE PATIENT WAS OUT OF TOWN AND FELL OFF HER BIKE AND HIT HER HEAD. THE PATIENT STATES THAT SHE FRACTURED HER CHEEK, BROKE ONE ARM, AND SPRAINED THE OTHER. THE CHEEK FRACTURE WAS ON THE OPPOSITE SIDE OF HER IOL. SHE SAW A PHYSICIAN WHO SAW THERE WAS A CRACK IN HER LENS. SHE LATER FOLLOWED UP WITH HER REGULAR PHYSICIAN, WHO STATED THAT THE LINE WAS PROBABLY THERE THE WHOLE TIME. SHE DOES NOT KNOW IF IT WAS EVER NOTED IN HER RECORDS PRIOR TO THE ACCIDENT. SHE ALSO DOES NOT KNOW IF SHE EVEN SAW THE LINE IN HER VISION PRIOR TO HER ACCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15119292 ↗
• MalfunctionApr 26, 2022Defective Device; Defective Device

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT LENS IS BEING RETURNED DUE TO DEFECT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 14208326 ↗
• MalfunctionFeb 25, 2022Defective Device; Defective Device

  A NON-HEALTH CARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THE LENS WAS DAMAGED HENCE IT WAS REMOVED IN THE SAME PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13601663 ↗
• InjuryAug 19, 2021Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS INJECTED. THE HAPTIC WAS REMAINED IN THE CARTRIDGE AND THE IMPLANTED IOL WAS LEFT WITH ONLY ONE HAPTIC. THE LENS WAS OFF CENTER IN THE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12344583 ↗
• MalfunctionMar 12, 2021Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING A CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, A SCRATCH WAS OBSERVED ON THE IMPLANTED IOL. ADDITIONAL INFORMATION WAS PROVIDED INDICATING THAT THE SCRATCHES WERE ON THE CENTRAL AREA. THE PATIENT KNOWS THAT THE LENS IS SCRATCHED, WHICH IS WHY SHE WANTS TO CHANGE IT, EVEN WITH 20/20 VISION. THE PATIENT'S SYMPTOMS ARE DESCRIBED AS "SEES SOMETHING ON THE SIDES". THE PATIENT IS GETTING BETTER BUT DOES NOT WANT A SCRATCHED LENS. AN IOL EXCHANGE HAS BEEN PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11478128 ↗