ACRYSOF® SN6AT3 (REF SN6AT3.165)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652249829), received between Jul 13, 2022 and Aug 31, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Defective Device” (1 report).

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.

• MalfunctionAug 31, 2023Material Opacification; Material Opacification

  A CONSUMER REPORTED THAT FOLLOWING TWELVE YEARS OF INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS CLOUDY NOTED. THE CONSUMER WANT IT REPLACED BUT SHE WAS TOLD IT MUST BE CLEANED WITH LASER WHICH WILL PROBABLY INCREASE THE NUMBER OF FLOATERS SHE ALREADY HAVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17660312 ↗
• MalfunctionApr 4, 2023Adverse 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 HAD DECREASED VISION AND STATED THAT LENS BECOMES GRAY. THE SURGEON SUGGESTED TO REPLACE THE IOL AS PER NEW INVESTIGATION FINDINGS. ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN STATED THAT, PATIENT HAD LOSS OF VISUAL ACUITY, REDUCED VISION, IOL OPACITY. THE PHYSICIAN POSSIBLY FURTHER LOSS OF VISUAL ACUITY WITHOUT IOL EXCHANGE. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT AND THERE WAS NO PATIENT HARM. PRE-OP MEASUREMENTS: (B)(6) 2022: OD 0,80 / OS 0,40 WITHOUT CORRECTION. OD 1,0 / OS 0,80 WITH CORRECTION. POST-OPERATIVE MEASUREMENTS (B)(6) 2023: OD 0,40 / OS WITHOUT CORRECTION. OD 0,63 / OS WITH CORRECTION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Visual Impairment

  MAUDE report 16672393 ↗
• MalfunctionNov 1, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT THERE WAS A FIBER IN THE IMPLANTED LENS. ADDITIONAL INFORMATION RECEIVED STATING THAT THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15706562 ↗
• MalfunctionJul 13, 2022Defective Device; Defective Device

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT PROCEDURE, FOUND TO HAVE AN INNER MATERIAL DEFECT HAD TO BE EXPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 15002145 ↗