AcrySof® UltraSert® AU00T0 (UDI 00380652394765)Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 00380652394765), received between Apr 22, 2019 and Sep 30, 2026 — classified as 6 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (10 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 25 most recent of 60 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Device Difficult to Setup or Prepare

  A non-health care professional reported that during an intraocular lens (IOL) implantation procedure, trailing haptic was stuck to the plunger, preventing implantation into the eye. The lens was replaced with a new one and functioned normally. The tip of the pre-loaded device was not in contact with the patient eye.Additional information has been requested but is not available at the time of this report.There are seven medical reports associated with same event. This file is 1 of 7.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948029 ↗
• MalfunctionSep 28, 2026Material Twisted/Bent

  A health care professional reported that during an intraocular lens (IOL) implantation procedure, twisted loop. There was no patient contact. The procedure was completed on the same day.Additional information has been requested but is not available at the time of this report.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50921264 ↗
• MalfunctionAug 6, 2026Failure to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50159811 ↗
• MalfunctionJul 21, 2026Device Difficult to Setup or Prepare

  Patient problems: Insufficient Information

  MAUDE report 25894503 ↗
• MalfunctionJul 7, 2026Device Difficult to Setup or Prepare

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE HAPTIC WAS DAMAGED DURING LENS LOADING INTO THE INJECTOR. THE LENS WAS NOT IMPLANTED AND DID NOT COME INTO CONTACT WITH THE PATIENT. A REPLACEMENT LENS WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25732421 ↗
• MalfunctionMay 20, 2026Failure to Advance

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PLUNGER ADVANCED BEYOND THE INTRAOCULAR LENS AND FAILED TO PROGRESS PROPERLY, CAUSING INTERNAL BENDING OF ITS SHAFT. THE SURGERY COMPLETED WITH REPLACEMENT LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 25230492 ↗
• MalfunctionApr 21, 2026Device Difficult to Setup or Prepare

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION PROCEDURE, THE TRAILING HAPTIC DID NOT UNFOLD PROPERLY. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE EVENT OCCURRED BEFORE SURGERY. IT WAS STATED THAT THE PROCEDURE WAS COMPLETED USING BACKUP LENS. THERE WAS NO PATIENT CONTACT AND NO CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24941943 ↗
• MalfunctionApr 21, 2026Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THEY NOTICED STRETCHED HAPTIC. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT THEY NOTICED BEFORE IMPLANTATION AND NO PATIENT CONTACT. THE SURGERY WAS COMPLETED USING UNSPECIFIED BACK UP LENS. NO FURTHER CONSEQUENCES WERE REPORTED FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24940839 ↗
• MalfunctionApr 10, 2026Scratched Material

  A HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SCRATCH LINE FOUND ON LENS OPTIC AFTER IMPLANTATION INTO PATIENT EYE. THE IOL WAS EXCHANGED WITH NEW SAME MODEL IOL DURING INITIAL PROCEDURE. THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THERE WAS NO FURTHER INTERVENTION NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24838651 ↗
• MalfunctionMar 9, 2026Device Damaged by Another Device

  A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING THE LOADING PROCEDURE, THE LENS WAS OBSERVED TO BE BROKEN FROM THE HAPTIC. THE PROCEDURE WAS COMPLETED ON THE SAME DAY, AND NO PATIENT CONTACT OCCURRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24543868 ↗
• MalfunctionFeb 13, 2026Failure to Advance

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PLUNGER OVER RODE THE LENS. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER UNSPECIFIED LENS DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24331060 ↗
• MalfunctionFeb 2, 2026Device Difficult to Setup or Prepare

  A HEALTHCARE PROFESSIONAL REPORTED AN ISSUE WHICH OCCURRED DURING A CATARACT SURGERY INVOLVING INTRAOCULAR LENS (IOL) IMPLANTATION. WHILE ADVANCING THE IOL THROUGH THE PRELOADED INJECTOR FOR IMPLANTATION INTO THE PATIENT¿S EYE, THE LEADING HAPTIC DID NOT UNFOLD PROPERLY INSIDE THE INJECTOR AND COULD NOT BE IMPLANTED AS INTENDED. PATIENT CONTACT OCCURRED. THE PROCEDURE WAS COMPLETED USING A BACKUP IOL OF THE SAME DIOPTER ON SAME DAY. THE PRODUCT IS NOT AVAILABLE FOR RETURN, IT WAS DISCARDED.

  Patient problems: Insufficient Information

  MAUDE report 24232501 ↗
• MalfunctionDec 23, 2025Failure to Advance; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF THE BLUE PLUNGER WENT PAST THE LENS, AND THE LENS COULD NO LONGER BE SALVAGED, ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 23876717 ↗
• MalfunctionDec 12, 2025Malposition of Device; Device Damaged by Another Device; Malposition of Device; Device Damaged by Another Device

  A PHYSICIAN REPORTED THAT DURING PHACOEMULSIFICATION AND INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE IOL INJECTOR INCORRECTLY POSITIONED THE LENS IN THE NARROW PART OF THE CARTRIDGE. THIS LED TO PINCHING AND DETACHMENT OF THE HAPTIC ELEMENT AND DAMAGE TO A SECTION OF THE OPTICAL PART OF THE IOL AS IT EXITED THE DEVICE. THE LENS DID NOT COME INTO CONTACT WITH THE PATIENT. THE LENS WAS REPLACED WITH AN IDENTICAL ONE OF THE SAME DIOPTER POWER AVAILABLE IN THE CLINIC. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23787999 ↗
• MalfunctionDec 10, 2025Material Twisted/Bent; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE IOL IS ADVANCED, THE POSTERIOR HAPTIC RUNS BESIDE THE STAMP. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THERE WAS NO PATIENT CONTACT AND HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23770724 ↗
• MalfunctionNov 7, 2025Device Damaged by Another Device; Device Damaged by Another Device

  A HEALTH CARE PROFESSIONAL REPORTED THAT PATIENT UNDERWENT CATARACT SURGERY. DURING PREPARATION THE INTRAOCULAR LENS (IOL) SYSTEM WAS PINCHED BY THE INJECTOR PLUNGER IN THE CARTRIDGE NOZZLE. A DIFFERENT, IDENTICAL IOL WAS USED FOR IMPLANTATION AND SURGERY COMPLETED WITHOUT ANY COMPLICATIONS. THERE NO PATIENT HARM AND NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23497415 ↗
• MalfunctionOct 27, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WAS WRONG. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION WAS REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 1 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23391063 ↗
• MalfunctionSep 12, 2025Device Damaged by Another Device; Device Damaged by Another Device

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DURING LENS INSERTION AND IMPLANTATION, THE LENS BODY WAS DAMAGED. THE LENSES COULD NOT BE IMPLANTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER LENS. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23039512 ↗
• MalfunctionSep 3, 2025Failure to Advance; Failure to Advance

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE PLUNGER PASSED THROUGH LENS. HENCE A NEW LENS WAS USED TO COMPLETE THE SURGERY ON THE SAME DAY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22950073 ↗
• MalfunctionAug 5, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A TRAILING HAPTIC WAS OBSERVED POSITIONED TO THE REAR. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH A DIFFERENT LENS, WITHOUT ANY HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22716644 ↗
• MalfunctionMay 30, 2025Material Deformation; Material Deformation

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INJECTOR TIP WAS FAULTY AND WAS NOT USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22114120 ↗
• MalfunctionMay 22, 2025Product Quality Problem; Product Quality Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF DEFECTIVE INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22072754 ↗
• MalfunctionJan 28, 2025Material Twisted/Bent; Failure to Eject; Material Twisted/Bent; Failure to Eject

  A NON-HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF JAMMED INJECTOR, HAPTIC OUT FIRST AND FOLDED. THERE WAS NO PATIENT CONTACT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21251847 ↗
• MalfunctionJan 27, 2025Crack; Crack

  A HEALTHCARE PROFESSIONAL REPORTED THAT LENS HAD A CRACK. LENS HAS BEEN PLACED IN EYE. IT IS UNKNOWN IF CRACK WAS ALREADY THERE OR IF THIS HAPPENED DURING THE PLACEMENT. THEY WE SUSPECT THAT IT WAS ALREADY THERE BECAUSE THE PLACEMENT WENT SMOOTHLY. ADDITIONAL INFORMATION RECEIVED STATING THAT LENS TEAR WAS NOT OBSTRUCTING VISION. THE CURRENT STATUS OF THE PATIENT WAS SATISFIED AND NO COMPLAINTS. THE PATIENT WAS ON INJECTIONS FOR MACULAR DEGENERATION, SO IT WAS NOT EXPECTED THAT VISION WOULD BECOME 1.0. BREAK LINE OF THE LENS OUTSIDE THE OPTICAL AXIS.

  Patient problems: Insufficient Information

  MAUDE report 21240959 ↗
• MalfunctionJan 17, 2025Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  A NON-HEALTH CARE PROFESSIONAL REPORTED WITH THE DESCRIPTION, THERE WAS A FAULTY LENS WHICH WAS UNABLE TO LOAD CORRECTLY AND THE HAPTIC WAS BROKEN. THERE WAS NO HARM AND NO CONTACT WITH THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, EVENT OCCURRED DURING LOADING AND THE SURGERY WAS ABLE TO COMPLETE WITH THE ANOTHER LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21181328 ↗