AcrySof Toric Aspheric UV Absorbing IOL SA6AT3 (REF SA6AT3.195)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652335751), received between Dec 22, 2021 and Nov 25, 2022 — classified as 3 injuries, 1 malfunction.

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.

• InjuryNov 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION AND STAR BURSTS AT NIGHT. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS ANISOMETROPIA. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 15864844 ↗
• MalfunctionSep 15, 2022Defective Device; Defective Device

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE INTRAOCULAR LENS HAD A PART OF A THIRD HAPTIC MASHED ON TO THE EDGE OF THE INTRAOCULAR LENS, IT ALMOST LOOKED LIKE SHEARED OFF TAIL OF A HAPTIC, INSPECTED BOTH HAPTICS WHICH WERE INTACT AND HAD TO EXPLANT THE ORIGINAL IOL AND USE BACKUP LENS.

  Patient problems: Insufficient Information

  MAUDE report 15427322 ↗
• InjuryAug 17, 2022Malposition of Device; Malposition of Device

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR NEAR VISION. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS IOL ROTATION RESULTING IN INDUCED ASTIGMATISM, UNDER CORRECTED MYOPIA. THERE WAS NO PATIENT HARM. THE PHYSICIAN PROGNOSIS WAS GOOD.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 15244946 ↗
• InjuryDec 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH PROFESSIONAL REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO DECREASED VISION AND A REFRACTIVE SURPRISE SEVEN MONTHS AFTER THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 13059234 ↗