ACRYSOF® SN6AT5 (REF SN6AT5.225)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652251044), received between Dec 20, 2021 and Feb 24, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Failure to Eject” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2023Failure to Eject; Failure to Eject

  A NON HEALTH CARE PROFESSIONAL REPORTED ABOUT A LENS DEFECTIVE NOTED DURING SURGERY. THE LENS WAS IMPLANTED AND EXPLANTED DURING THE SAME PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING WHEN THE LENS WAS BEING EJECTED IT GOT CAUGHT AND WAS CUT INTO PIECES TO BE REMOVED FROM THE EYE.

  Patient problems: Insufficient Information

  MAUDE report 16434630 ↗
• MalfunctionOct 31, 2022Break; Failure to Eject; Break; Failure to Eject

  AN HEALTH CARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THE LENS BROKE AS THE SURGEON WAS TRYING TO INSERT LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED AND IT WAS CLARIFIED THAT DURING INSERTION THE PLUNGER WENT OVER THE LENS AND TRAILING HAPTIC WAS BROKEN UPON INSERTION. BROKEN IOL SUCCESSFULLY REMOVED AND BACKUP LENS USED. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT AND THERE WAS NO PATIENT HARM. THE SYMPTOMS HAVE RESOLVED AND THE PROGNOSIS WAS GOOD. NO INTERVENTION WAS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15697866 ↗
• MalfunctionOct 29, 2022Crack; Crack

  AN OPHTHALMIC SURGEON REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A SLIGHTLY OFF-CENTER CRACK ON IOL WON'T HAVE TOO MANY CONSEQUENCES FOUND AFTER IOL INJECTION. THE IMPLANT WAS PERFECTLY NORMAL BEFORE GOING INTO THE INJECTOR. THE ZONULA WAS VERY FRAGILE, HENCE DID NOT WANT TO TAKE THE RISK OF REMOVING THE IOL AND PUTTING ANOTHER ONE. THE SURGEON TRIED TO RUB THE BACK SIDE OF THE IMPLANT, HOPING THAT IT WAS JUST DUST STUCK TO THE IMPLANT, BUT WITHOUT SUCCESS. ADDITIONAL INFORMATION WAS RECEIVED STATING THE PATIENT WAS SEEN ONLY ONE DAY AFTER SURGERY FOR THE MOMENT, BUT THE VISUAL ACUITY OF THE PATIENT AT ONE DAY AFTER SURGERY WAS RATHER REASSURING AT 6/10 WITHOUT CORRECTION EVEN IF THE FISSURE WAS VISIBLE, A LITTLE OFF CENTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15697087 ↗
• MalfunctionDec 20, 2021Scratched Material; Scratched Material

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A MARK IN THE IOL WAS NOTICED. THE IOL WAS REPLACED WITH ANOTHER LENS DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13043471 ↗