ACRYSOF® SN60AT (REF SN60AT.215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380650130334), received between Apr 8, 2021 and Aug 21, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2025Product Quality Problem; Product Quality Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS WAS DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22860471 ↗
• MalfunctionMay 13, 2025Material Deformation; Material Deformation

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PATIENT HAD IOLS WITH SIGNIFICANT GLISTENING'S THAT SEEM TO BE VISUALLY SIGNIFICANT. THE SYMPTOMS CONTINUED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Insufficient Information

  MAUDE report 22011247 ↗
• MalfunctionMar 14, 2024Scratched Material; Scratched Material

  A NURSE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, WHEN THE IOL WAS IMPLANTED INTO THE PATIENT'S EYE, A SCRATCH WAS NOTICED ON THE OPTIC ELEMENT OF THE IOL. THE IOL WAS SUCCESSFULLY REMOVED AND A NEW ONE WAS IMPLANTED IN AN INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18901994 ↗
• MalfunctionJul 31, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER IMPLANTATION OF THE IOL HAD MASSIVE DEPOSITS ON THE UPPER SURFACE. AT FIRST THEY WERE PRACTICALLY IMPOSSIBLE TO REMOVE. SURGEON THEN TURNED THE CANNULA AND WENT DIRECTLY TO THE LENS SURFACE WITH THE SUCTION OPENING. THE DEPOSITS COULD BE REMOVED TO A LARGE EXTENT. SURGEON IS CURIOUS HOW THE LENS LOOKS NEXT WEEK IN MYDRIASIS AND WHETHER ANY RESIDUE CAN BE REMOVED WITH THE YAG LASER. THE DEPOSITS LOOKED KIND OF GREASY TO SURGEON . SURGEON ADDED THAT THIS WOULD FIT BECAUSE THEY FELT SO COMFORTABLE ON THE LENS. SURGEON SAID THAT WHERE THESE DEPOSITS COULD HAVE COME FROM IS A COMPLETE MYSTERY TO HIM - THEY CAN'T COME FROM THE CARTRIDGE, SINCE THE TOP IS INSIDE THE CARTRIDGE WHEN IT IS ROLLED UP. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT CONTINUED MINOR DEPOSITS ON THE IOL WITH INCREASED GLARE SENSITIVITY. AS PER THE SURGEON THERE WAS NO REQUIREMENT OF MEDICAL OR SURGICAL INTERVENTION. HOWEVER SURGEON ALSO MENTIONED THAT POSSIBLY LATER ATTEMPT YAG POLISHING. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT.

  Patient problems: Visual Disturbances

  MAUDE report 17423100 ↗
• MalfunctionApr 8, 2021Scratched Material; Scratched Material

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A SCRATCH WAS FOUND AT THE LENS OPTIC AFTER IMPLANTATION. THE LENS WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED THE SAME DAY WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11634648 ↗