ACRYSOF® SN6AT3 (REF SN6AT3.195)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652249881), received between Apr 8, 2021 and Nov 20, 2023 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2023Break; Break

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS BROKEN BEFORE IMPLANTATION. THERE WAS PATIENT CONTACT NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18169012 ↗
• MalfunctionFeb 28, 2023Defective Device; Defective Device

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS WASTED DUE TO DEFECT.

  Patient problems: Insufficient Information

  MAUDE report 16451290 ↗
• MalfunctionJan 19, 2023Scratched Material; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, TORN OR BROKEN HAPTIC WAS FOUND. THERE WAS A BLEMISH ON THE LENS WAS ALSO REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING LENS DID HAVE A BLEMISH ON IT AND NOT TORN OR BROKEN LENS.

  Patient problems: Insufficient Information

  MAUDE report 16204510 ↗
• InjuryJul 4, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED VISION BECAME BLURRY AND DOUBLED. THE SURGEON HAD TOLD THAT, IOL WAS IN THE CAPSULAR BAG, BUT THE CAPSULAR BAG WAS FLAPPING IN THE BREEZE, SO TO SPEAK, FALLING BACK FROM ITS POSITION BEHIND THE IRIS AS THE PATIENT BLINKED. THE SURGEON DIAGNOSED IT AS DISLOCATED LENS BAG COMPLEX. THE BAG APPEARS TO HAVE LITTLE TO NO FIBROSIS, AND THIS IS WHAT WE CALL A DEAD BAG. THE EYE HAD SOME ANTERIOR VITREOUS ABOUT THE LENS BAG COMPLEX. THE SURGEON DID EXPLANT THE IOL, PARS PLANA VITRECTOMY, INTRASCLERAL HAPTIC FIXATION, LIMBAL RELAXING INCISIONS DURING SECONDARY PROCEDURE. IN THE SURGEON¿S OPINION, THE PRODUCT DID NOT CAUSE OR CONTRIBUTED TO THE EVENT. IT WAS INDICATED THAT THERE WAS NO SUPPORT. THERE WAS NO PATIENT HARM. PATIENT¿S ISSUE HAS BEEN RESOLVED. SURGEON¿S PROGNOSIS IS EXCELLENT.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 14906661 ↗
• InjuryDec 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION. THE IOL WAS EXCHANGED WITH AN ALTERNATE IOL APPROXIMATELY 1 MONTHS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THERE WAS NO PATIENT HARM. THE PATIENT ISSUE HAS BEEN RESOLVED.

  Patient problems: Blurred Vision

  MAUDE report 12950014 ↗
• MalfunctionApr 8, 2021Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  ADDITIONAL INFORMATION RECEIVED, INDICATED THAT THE DEVICE WAS IN CONTACT WITH THE PATIENT'S EYE. THE EVENT OCCURRED, DURING THE PROGRESSION OF THE IMPLANT IN THE CARTRIDGE. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11634411 ↗