AcrySof® UltraSert® AU00T0 (UDI 00380652394864)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00380652394864), received between Mar 23, 2021 and Apr 20, 2026 — classified as 2 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Failure to Eject” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Failure to Deliver; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS NOT PLACED DUE TO NOT PROPERLY OUT OF SHOOTER. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THERE WAS NO PATIENT CONTACT AND NO CONSEQUENCES FOR THE PATIENT. THE SURGERY COMPLETED USING THE BACKUP IOL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24925860 ↗
• MalfunctionFeb 13, 2026Device Difficult to Setup or Prepare

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION, LEADING HAPTIC WAS STIFF AND STUCK. IT WAS ALSO STATED THAT PROCEDURE WAS COMPLETED USING REPLACEMENT LENS WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24331112 ↗
• MalfunctionJan 29, 2026Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE LENS OPENED IN THE EYE, IT LACKED HAPTICS. VISCOELASTICS WERE USED, WHICH HAD BEEN KEPT AT ROOM TEMPERATURE FOR ONE HOUR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24209196 ↗
• MalfunctionJun 6, 2025Failure to Fold; Failure to Fold

  A HEALTHCARE PROFESSIONAL REPORTED WITH THE DESCRIPTION OF INTRAOCULAR LENS (IOL) FAILED TO LOAD AND NO HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22156871 ↗
• MalfunctionMay 20, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  A NURSE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHILE THE DOCTOR WAS IMPLANTING THE LENS, THE HAPTIC WAS POSITIONED INCORRECTLY. A NEW LENS WAS USED INSTEAD TO COMPLETE THE SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22054253 ↗
• MalfunctionMar 10, 2025Device Difficult to Setup or Prepare; Failure to Unfold or Unwrap; Device Difficult to Setup or Prepare; Failure to Unfold or Unwrap

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LEADING HAPTIC WAS STUCK UNDER THE LENS. THE DEVICE HAD CONTACT WITH PATIENT BUT NO HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21558015 ↗
• MalfunctionFeb 18, 2025Device Damaged by Another Device; Device Damaged by Another Device

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A CRACKED LENS WAS NOTED. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THERE WAS AN UNUSUAL DENT ON THE OPTIC WAS OBSERVED DURING INJECTION. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21394055 ↗
• MalfunctionApr 30, 2024Failure to Fold; Device Damaged by Another Device; Failure to Eject; Failure to Fold; Device Damaged by Another Device; Failure to Eject

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) PROCEDURE, THE LENS DID NOT FOLD CORRECTLY. PLUNGER WENT OVER THE LENS AND DAMAGED THE LENS. THE PROCEDURE HAS BEEN COMPLETED WITH ANOTHER LENS.

  Patient problems: Insufficient Information

  MAUDE report 19213207 ↗
• MalfunctionJan 9, 2024Difficult to Fold, Unfold or Collapse; Defective Device; Failure to Eject; Difficult to Fold, Unfold or Collapse; Defective Device; Failure to Eject

  A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF DEFECTIVE INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18473625 ↗
• InjuryAug 22, 2023Defective Component; Material Split, Cut or Torn; Defective Component; Material Split, Cut or Torn

  A HEALTH CARE PROFESSIONAL REPORTED THAT, DURING THE INTRAOCULAR LENS IMPLANT (IOL) PROCEDURE, WHEN PHYSICIAN IMPLANTED, HE NOTICED THAT A HAPTIC HAS BROKEN. WHEN HE WAS READY TO TAKE THE LENS WITH A CLIP TO REMOVE IT FROM THE EYE, HE NOTICED THAT AS HE HOLD THE LENS WITH THE CLIP, THE LENS IS UNDONE INTO PIECES. THE LENS WAS BROKEN DOWN IN THE EYE. HE FINALLY MANAGED TO REMOVE ALL THE LENS FRAGMENTS. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, IMPACT ON THE PATIENT WAS LENGTHENING OF THE SURGICAL ACT WHEN HAVING TO EXPLANT THE LENS. PAIN DURING SURGERY AND MAJOR POST-SURGICAL INFLAMMATION. NO TOTAL VISUAL RECOVERY AFTER ONE MONTH, WITH EDEMA / ENDOTHELIAL FIBROSIS. MAXIMUM CORRECTED VISUAL ACUITY ONE MONTH AFTER THE INTERVENTION WAS 0.4. WITH NEW LENS IMPLANTED IN THE SAME SURGICAL ACT. THE LENS WHEN IMPLANTED IT WAS OBSERVE THAT THE HAPTIC IS BROKEN, BUT WHAT IS SURPRISING IS THAT WHEN EXPLANTING THE IOL IT BREAKS AS SOON AS IT TOUCHES IT WITH THE CLAMP OF TECH. THE MANUAL IMPLANT WAS PERFORMED AT PHYSICIAN INDICATION. THE LENSES UNFOLD VERY ABRUPTLY AND WE HAVE HAD COMPLICATIONS WITH RUPTURE OF THE POSTERIOR CHAMBER, IN EYES ALREADY MORE DIFFICULT. THE BEHAVIOR OF THE IOL M

  Patient problems: Corneal Edema; Fibrosis; Inflammation; Visual Disturbances

  MAUDE report 17596383 ↗
• MalfunctionJul 24, 2023Failure to Eject; Failure to Eject

  A HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS STUCK IN THE INJECTOR DURING INSERTION. THERE WAS PATIENT CONTACT WITH THE PRODUCT BUT THERE WAS NO PATIENT HARM. THE SURGERY WAS COMPLETED WITH BACK UP LENS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17379184 ↗
• MalfunctionApr 6, 2023Break; Malposition of Device; Break; Malposition of Device

  A PHYSICIAN REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE AFTER IMPLANTING IN THE CAPSULAR BAG AND IT WAS OBSERVED THAT THE LENS CAME WITHOUT ONE OF THE HAPTICS. THE LENS WAS LEFT IN THE SAME WAY, SINCE THE PATIENT HAD FLACCID IRIS AND IT WAS ALSO REQUIRED TO PERFORM A VITRECTOMY. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE PATIENT IS UNDER OBSERVATION AND WILL BE ASSESSED FOR POSSIBLE LENS EXPLANTATION IN APPROXIMATELY 1 MONTH. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THE LENS WAS NOT EXPLANTED INTRA SURGICALLY FOR THE FOLLOWING REASONS: THE PATIENT HAD EXTREMELY FLACCID IRIS AND APPEARED TO HAVE DIALYSIS ON THE UPPER IRIS. CUTTING, REMOVING, AND REINSERTING THE LENS WOULD HAVE IMPLIED GREATER TRAUMA TO THE IRIS AND INVOLVEMENT OF THE CORNEAL ENDOTHELIUM; WE HAD SURGERY FOR A COMPLEX RETINAL DETACHMENT WITH HEMOVITREOUS AHEAD. AND SHE NEEDED THE ANTERIOR SEGMENT IN THE BEST POSSIBLE STATE TO BE ABLE TO PERFORM THE VITRECTOMY AND MANAGEMENT OF FIBROUS MEMBRANES; THE LENS WAS LEFT IN AN ACCEPTABLE POSITION WITH THE OPTICAL ZONE RELATIVELY WELL CENTERED. AT THE DATE OF THE LAST VISIT, THE PATIENT HAD A BEST CORRECTED VISUAL ACUITY OF 20/50 WITH HER

  Patient problems: Visual Impairment

  MAUDE report 16688477 ↗
• MalfunctionOct 14, 2022Failure to Eject; Failure to Eject

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS LOADING NORMALLY BUT DID NOT GET LOOSE FROM THE INJECTOR AND CAME OUT WHEN THE INJECTOR WAS TAKEN OUT OF THE EYE. ANOTHER IOL WAS USED AND THAT WORKED NORMALLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15605832 ↗
• InjuryOct 11, 2022Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

  A PHYSICIAN REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THE PLUNGER WAS PROVIDING SIGNIFICANT RESISTANCE DURING IMPLANTATION, THEN GAVE WAY, RESULTING IN THE LENS FIRING OUT OF THE INJECTOR AND THROUGH THE POSTERIOR CAPSULE AND INTO THE VITREOUS. ADDITIONAL INFORMATION HA BEEN REQUESTED AND RECEIVED STATING THE PATIENT WAS HARMED BY THE INJECTOR SHOOTING OUT THE LENS WITH UNUSUAL FORCE THAT LED TO HER NEEDING A VITRECTOMY AND LENS REPLACEMENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear

  MAUDE report 15579097 ↗
• MalfunctionFeb 10, 2022Failure to Advance; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE LENS STUCK IN CARTRIDGE. THERE WAS PATIENT CONTACT BUT NO HARM WAS REPORTED. THE LENS WAS REPLACED WITH A BACK UP LENS IN THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13503990 ↗
• MalfunctionNov 30, 2021Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  A NON HEALTHCARE PROFESSIONAL REPORTED ABOUT TWO PRELOADED INTRAOCULAR DEVICE WITH A DESCRIPTION LENS DID NOT UNFOLD PROPERLY. THE PROCEDURE WAS COMPLETED WITH NEW LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12889834 ↗
• MalfunctionNov 30, 2021Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  A NON HEALTHCARE PROFESSIONAL REPORTED ABOUT TWO PRELOADED INTRAOCULAR DEVICE WITH A DESCRIPTION LENS DID NOT UNFOLD PROPERLY. THE PROCEDURE WAS COMPLETED WITH NEW LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12889832 ↗
• MalfunctionNov 29, 2021Material Twisted/Bent; Failure to Eject; Material Twisted/Bent; Failure to Eject

  A SURGEON REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE PLUNGER DID NOT PUSH THE LENS THROUGH THE HAPTIC, IT HAD PUSHED THROUGH THE OPTIC AREA. THE LENS FOUND TO BE DEFECTIVE. IT WAS ALSO REPORT THAT THE LENS WAS IMPLANTED WITHOUT ANY PROBLEM, HOWEVER THE SECOND HAPTIC WAS OUT OF THE INCISION AND THE PHYSICIAN HAD TO REPOSITION IT. ADDITIONAL INFORMATION RECEIVED BY SURGEON THAT, THE PLUNGER CAME OUT CROOKED, AND DID NOT PUSH THE HAPTIC, BUT PUSHED THE OPTIC, CAUSING THE SECOND HAPTIC TO COME OUT STRANGE AND ALMOST OUT OF THE EYE. THE LENS WAS IMPLANTED WITH A LITTLE MANIPULATION BY THE DOCTOR. THAT THE INJECTOR DID NOT DRAG THE LENS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12883955 ↗
• MalfunctionMar 23, 2021Failure to Advance; Failure to Advance

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PRELOADED LENS WOULD NOT DEPLOY FROM THE DELIVERY SYSTEM. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11555752 ↗