ACRYSOF® SN6AT4 (REF SN6AT4.205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380652250436), received between Jun 13, 2022 and Apr 29, 2026 — classified as 5 injuries, 3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Failure to Deliver

  A PHARMACIST REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, THERE WAS PROBLEM DURING IMPLANT DELIVERY. THERE WAS NO CONSEQUENCES FOR THE PATIENT. A BACK-UP LENS WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25038244 ↗
• MalfunctionSep 11, 2025Material Deformation; Material Deformation

  A NON-HEALTH CARE PROFESSIONAL REPORTED WITH THE DESCRIPTION DAMAGED OR DENTED MERCHANDISE.

  Patient problems: Insufficient Information

  MAUDE report 23025971 ↗
• InjuryMar 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT APPROXIMATELY 9 YEARS AFTER AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS HAVING A LOT OF ALLERGIES AND NOTICED A CHANGED IN HER VISION. THE PATIENT WENT TO THE EMERGENCY ROOM (ER) AND RECEIVED UNSPECIFIED ALLERGY MEDICATIONS BUT HAD NOT SEEN ANY IMPROVEMENT IN HER VISION. THE PATIENT DECIDED THAT SHE WOULD SEE AN EYE CARE PROFESSIONAL (ECP) ABOUT HER ISSUES AND FOR AN OVERALL EXAM. SHE CANNOT TELL IF BLURRY VISION WAS IN BOTH EYES (OU), OR JUST ONE EYE. SHE ONLY HAD AN IMPLANT CARD FOR 1 EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision; Hypersensitivity/Allergic reaction

  MAUDE report 18824443 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT HAD SIGNIFICANT AMOUNT OF UVEITIS. AND BARELY SIX WEEKS LATER, PATIENT HAD DENSE FIBROSIS ON BOTH THE POSTERIOR AND ANTERIOR SURFACE. THERE WAS REGROWTH OBSERVED IN THE ANTERIOR CAPSULE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 18139903 ↗
• InjuryJul 25, 2023Defective Device; Defective Device

  A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION. THE LENS WAS EXPLANTED AND REPLACED WITH OTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS REFRACTIVE SURPRISE. ADDITIONAL INFORMATION WAS RECEIVED AS SURGEON NOTED SCUFFED INTRAOCULAR LENS.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 17387829 ↗
• MalfunctionJun 20, 2023Scratched Material; Scratched Material

  A PHYSICIAN REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT VISION IS 20/40 UNCORRECTED. THE PATIENT FINAL REFRACTION IS PLANO -1.25 X 135. THE PATIENT NOTES A VAGUE "WHITE CURVED LINE" NASALLY. IT IS MADE BETTER WITH HER POST OPERATION REFRACTION IN THE PHOROPTER. SHE SEES IT INTERMITTENTLY. THE PATIENT IOL HAS A SCUFF MARK TEMPORALLY RUNNING HORIZONTALLY. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, PASSING THROUGH THE CARTRIDGE MIGHT HAVE CAUSED THE SCUFF MARK TEMPORALLY.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 17163317 ↗
• InjuryMay 31, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT DID NOT SEE COLORS EQUALLY BETWEEN THE TWO EYES. WHEN OUTSIDE, THE VISION IN LEFT EYE WENT WHITE AND COULD NOT SEE OUT OF IT. HAD BLINDING GLARE WHICH WAS NOTED MORE OUTSIDE OR WITH INDOOR LIGHT SOURCES. THE PATIENT HAD A YAG POSTERIOR CAPSULE WHICH DID NOT HELPED. IT WAS NOTICED THAT IOL IS OUT OF PLACE AND PATIENT HAS POSTERIOR VITREOUS DETACHMENT (PVD). ADDITIONAL INFORMATION HAD BEEN REQUESTED.

  Patient problems: Visual Disturbances; Visual Impairment; Vitreous Detachment

  MAUDE report 17029100 ↗
• InjuryJun 13, 2022Malposition of Device; Appropriate Device Problem Term/Code Not Available; Malposition of Device; Appropriate Device Problem Term/Code Not Available

  A NURSE REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED 3 MONTH AFTER IMPLANTATION DUE TO BLURRED VISION, TORIC ROTATORY AND POWER CHANGE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 14675298 ↗