ACRYSOF® SN6AT4 (REF SN6AT4.290)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652250603), received between May 9, 2022 and May 9, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PROCEDURE MANAGER REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INCISION WAS ENLARGED SLIGHTLY AND INSERTED INTO THE EYE, WHILST INJECTING THE IOL INTO THE EYE THE TRAILING HAPTIC WAS TORN FROM THE OPTIC. THE SURGEON THEN CUT THE IOL OUT AND ASKED FOR THE BACKUP LENS. THE SURGEON ASKED FOR A CARTRIDGE AND A BLUNT PROBE TO PUSH THE IOL DOWN THE CARTRIDGE AND INTO THE EYE. UNFORTUNATELY, DURING INSERTION OF THE IOL, THE POSTERIOR CAPSULE RUPTURED AND AN ANTERIOR VITRECTOMY WAS PERFORMED THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS LEFT WITHOUT A LENS IMPLANT WITH A VIEW TO RETURN FOR A SECONDARY LENS IMPLANT AT A LATER DATE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Capsular Bag Tear

  MAUDE report 14336681 ↗
• InjuryMay 9, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  A PROCEDURE MANAGER REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INCISION WAS ENLARGED SLIGHTLY AND INSERTED INTO THE EYE, WHILST INJECTING THE IOL INTO THE EYE THE TRAILING HAPTIC WAS TORN FROM THE OPTIC. THE SURGEON THEN CUT THE IOL OUT AND ASKED FOR THE BACKUP LENS. THE SURGEON ASKED FOR A CARTRIDGE AND A BLUNT PROBE TO PUSH THE IOL DOWN THE CARTRIDGE AND INTO THE EYE. UNFORTUNATELY, DURING INSERTION OF THE IOL, THE POSTERIOR CAPSULE RUPTURED AND AN ANTERIOR VITRECTOMY WAS PERFORMED THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS LEFT WITHOUT A LENS IMPLANT WITH A VIEW TO RETURN FOR A SECONDARY LENS IMPLANT AT A LATER DATE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Eye Injury

  MAUDE report 14336660 ↗