ACRYSOF® SN6AT3 (REF SN6AT3.210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00380652249911), received between Mar 23, 2021 and May 29, 2026 — classified as 6 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (2 reports).

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2026Failure to Unfold or Unwrap

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS COULD NOT BE IMPLANTED BECAUSE OF AN INJECTOR PROBLEM. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE REPORTED INCIDENT OCCURRED DURING THE IMPLANTATION PROCEDURE. THE IMPLANTATION FAILED BECAUSE ONE OF THE IMPLANT HAPTICS REMAINED ADHERED TO THE OPTIC, PREVENTING PROPER PLACEMENT. THE OPERATING ROOM TEMPERATURE WAS WITHIN THE RECOMMENDED RANGE, BETWEEN 18°C AND 23°C AT THE TIME OF THE PROCEDURE. HOWEVER, IT WAS UNKNOWN WHETHER THE IMPLANT HAD BEEN ALLOWED TO EQUILIBRATE TO THE OPERATING ROOM TEMPERATURE FOR AT LEAST 30 MINUTES PRIOR TO USE. THE INCIDENT DID NOT OCCUR DURING THE PREPARATION OF THE IMPLANT PRIOR TO INJECTION, NOR DURING THE PROGRESSION OF THE IMPLANT WITHIN THE CARTRIDGE. THE ISSUE OCCURRED DURING IMPLANTATION IN THE PATIENT¿S EYE, AT THE TIME OF INSERTION.

  Patient problems: Insufficient Information

  MAUDE report 25330422 ↗
• MalfunctionJan 15, 2024Material Discolored; Material Discolored

  A PHYSICIAN REPORTED THAT DURING SURGERY, THE AFOREMENTIONED PATIENT UNDERWENT CATARACT SURGERY AND THE AFOREMENTIONED LENS WAS IMPLANTED. THERE WAS NO NEW DEVELOPMENT IN THE PROCEDURE OR SUBSEQUENT REVIEWS. AT A SCHEDULED APPOINTMENT, THE PATIENT ARRIVED AT THE CONSULTATION AND DURING THE EXAMINATION THE DOCTOR FOUND THAT THE LENS IMPLANTED APPROXIMATELY 7 YEARS AGO SHOWN A WHITE COLOR THAT ALMOST COMPLETELY PREVENTS VISION. THE DOCTOR IS GOING TO CARRY OUT A SECOND EVALUATION OF THIS NOVELTY, TO DECIDE THE CORRECTIVE PROCEDURE, HE HAS TWO OPTIONS AT THE MOMENT: 1.- REMOVE THE LENS AND IMPLANT A SINGLE PIECE 2.- REMOVE THE LENS AND IMPLANT A THREE-PIECE LENS. EVERYTHING WILL DEPEND ON THE STATE OF THE POSTERIOR CAPSULE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT PATIENT WAS WITH LOW VISION DUE TO THE CONDITION OF THE LENS.

  Patient problems: Visual Impairment

  MAUDE report 18510188 ↗
• MalfunctionMay 3, 2023Device Damaged by Another Device; Failure to Eject; Device Damaged by Another Device; Failure to Eject

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE INJECTOR PUSHED OVER THE LENS AND LENS WAS BROKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16859505 ↗
• InjuryApr 21, 2023Unintended Ejection; Unintended Ejection

  AN OTHER HEALTHCARE PROFESSIONAL REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS IMPLANTED UPSIDE DOWN. THE SURGERY WAS COMPLETED WITHOUT FLIPPING THE IOL AND IT REMAINS IMPLANTED IN THE PATIENT'S EYE. THERE WAS POSTERIOR VITREOUS DETACHMENT NOTICED ON POST OPERATIVE DAY 1. THE PATIENT ALSO HAD HAZY VISION DUE TO FIBRIN ON THE IOL. THEREFORE, THE PATIENT WAS TREATED WITH INCREASED DOSE OF TOPICAL CORTICOSTEROIDS. ADDITIONAL INFORMATION RECEIVED STATED THAT PATIENT FELT THAT THE LEFT EYE WAS LIKE A THUMB PRINT IN HER EYE, AND HAD MONOVISION. IT APPEARED THAT SHE REACTED TO PRED FORTE, SO THE DOCTOR STOPPED THIS TREATMENT.

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

  MAUDE report 16787081 ↗
• InjuryDec 15, 2022Device Damaged by Another Device; Device Damaged by Another Device

  A PHARMACIST REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THIS REPORT OF THE IMPLANT HAD A MARK ON THE OPTIC, NEAR THE VISUAL AXIS, LIKE A BIG SCRATCH OF 2-3 MM, STRAIGHT, AS IF THE IMPLANT WAS BROKEN. THE SURGEON DID NOT NOTICE THIS WHEN LOADING THE IMPLANT INTO THE CARTRIDGE (NOT DONE UNDER THE OPERATING MICROSCOPE) AND IT IS ALSO VERY POSSIBLE THAT THE PLUNGER OF THE DEVICE USED TO PUT THE IMPLANT IN HAS DAMAGED THE OPTIC (MALPOSITION). DOUBT ON MANUFACTURING DEFECT. EXPLANTATION OF THE IMPLANT, LONG PROCEDURE ON A FRAGILE EYE AND A MONOPHTHALMIC PATIENT. AFTER THE EXPLANTATION, WE HAD TO STOP THE PROCEDURE BECAUSE THE OCULAR TENSION INCREASED AND DID NOT ALLOW US TO CONTINUE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING IMMEDIATE CONSEQUENCES WERE THE ENLARGEMENT OF THE INCISION, AN EXTENDED WORK AND THEN AN IMPORTANT CORNEAL OEDEMA THE NEXT DAY. THE IMPLANT WAS EXPLANTED AND CUT IN SEVERAL PIECES IN THE EYE WITH THE SCISSORS AND WAS THROWN WAY. DURING THE EXPLANTATION, THERE WERE OTHER COMPLICATIONS SUCH AS INCREASED INTRAOCULAR PRESSURE AND A PROLAPSE OF THE IRIS THROUGH ALL THE INCI

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Corneal Edema; Eye Injury; Intraocular Pressure Increased; Prolapse

  MAUDE report 15986453 ↗
• InjuryApr 21, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING IMPLANTATION OF AN EXPIRED INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED SWOLLEN RETINA FOR MONTHS. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT HAD MACULAR EDEMA WHICH WAS RESOLVED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Macular Edema; Retinal Tear; Visual Impairment

  MAUDE report 14165568 ↗
• MalfunctionJul 22, 2021Defective Device; Defective Device

  A FACILITY REPRESENTATIVE REPORTED VIA A REPLY CARD THAT THE LENS WAS DEFECTIVE AND NOT USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12210067 ↗
• MalfunctionMay 20, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A NURSE REPORTED THAT THERE IS A DOT IN THE MIDDLE OF AN INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION WAS PROVIDED THAT DURING AN IOL IMPLANT PROCEDURE, AFTER INSERTING THE LENS, THE DOT WAS NOTED. THE PROCEDURE WAS COMPLETED THE SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11854580 ↗
• InjuryApr 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE 21.0 LENS WAS EXCHANGED FOR A 21.5 LENS 21.0 LENS DUE TO WRONG POWER, ROTATION ISSUE AND MISSED AIM. THIS DOES NOT MEET CRITERIA FOR REPORTING BASED ON APPLICABLE MEDICAL DEVICE REGULATIONS. A LENS EXCHANGE FROM ONE POWER TO A DIFFERENT POWER IS AN ATTEMPT TO ADJUST OR FINE TUNE THE REFRACTIVE OUTCOME TRYING TO ACHIEVE A DESIRED TARGET WHEN THE INITIAL LENS CALCULATIONS DID NOT ACHIEVE THE INTENDED OUTCOME. THERE IS NO REPORTED DEFECT OR FAULT WITH THE LENS.

  Patient problems: Insufficient Information

  MAUDE report 11753807 ↗
• InjuryApr 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT AFTER THE INITIAL INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A PATIENT COMPLAINED OF "SIGNIFICANT GLARE AND HALOS". THIS REQUIRED THE REMOVAL OF THE IOL IN A SECONDARY SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 11641781 ↗
• InjuryMar 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION AND A REFRACTIVE SURPRISE. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 11552042 ↗