AcrySof® UltraSert® AU00T0 (UDI 00380652394819)Recalls & reported problems

Summary

The FDA's MAUDE database contains 85 adverse event reports that list this exact device (DI 00380652394819), received between Mar 29, 2021 and Sep 30, 2026 — classified as 5 injuries, 80 malfunctions.

The most frequently reported specific device problem is “Failure to Eject” (19 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 85 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 5 of 7.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948033 ↗
• MalfunctionSep 16, 2026Break; Device Difficult to Setup or Prepare

  A physician reported that during the intraocular lens (IOL) implant procedure, The trailing haptic of the lens was missing when the lens was loaded into capsular bag. The surgeon reported that resistance/friction was encountered with the plunger during delivery of the IOL. The surgeon explanted the damaged IOL and implanted a new IOL to complete the procedure. There was no further patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50783880 ↗
• MalfunctionAug 7, 2026Device Difficult to Setup or Prepare

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50175533 ↗
• MalfunctionJul 27, 2026Device Difficult to Setup or Prepare

  Patient problems: Insufficient Information

  MAUDE report 50017219 ↗
• MalfunctionMay 22, 2026Failure to Deliver; Device Damaged by Another Device

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, DURING LOADING OF THE LENS, THE LENS WAS NOT PUSH OUT BY THE PLUNGER, SURGEON TRY TO REMOVE THE LENS, UNFORTUNATELY ONE OF THE HAPTIC BROKEN. HENCE, DOCTOR DECIDED TO USE ANOTHER BACKUP LENS, AND IT WAS GOOD WITHOUT ANY COMPLICATION. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT CONTACT. 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 25254911 ↗
• MalfunctionApr 20, 2026Device Difficult to Setup or Prepare

  A HEALTH CARE PROFESSIONAL REPORTED THAT BEFORE SURGERY TRAILING HAPTIC REMAINED STUCK. SURGERY WAS COMPLETED BY THE UNSPECIFIED BACKUP LENS WITHOUT ANY CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24926127 ↗
• MalfunctionApr 15, 2026Material Twisted/Bent

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, IT WAS NOTED THAT THE TRAILING HAPTIC WAS STRAIGHT. THE SURGEON CHECKED UNDER THE MICROSCOPE FIRST AND NOTED THAT THE TRAILING HAPTIC WAS STUCK BETWEEN PLUNGER AND CLEAR PLASTIC. THE LENS WAS REMOVED IN AN INITIAL PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 24884558 ↗
• MalfunctionApr 9, 2026Device Difficult to Setup or Prepare

  A PHARMACIST REPORTED THAT THE IMPLANT PRESENTED WITH THE LEADING HAPTIC ALREADY UNFOLDED IN THE INJECTOR AND BECAME STUCK IN THE INCISION. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24831872 ↗
• MalfunctionApr 6, 2026Device Difficult to Setup or Prepare

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE HAPTIC OF THE LENS WAS POSITIONED TOO FAR BACK. HENCE IT WAS NOT INJECTED INTO THE EYE. THE LENS WAS DELIVERED INSIDE THE CARTRIDGE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24788853 ↗
• MalfunctionMar 26, 2026Device Difficult to Setup or Prepare

  A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF DELIVERY SYSTEM FAULTY/FAILED / DID NOT ADVANCE/LOAD/INJECT AS EXPECTED.

  Patient problems: Insufficient Information

  MAUDE report 24700513 ↗
• MalfunctionFeb 20, 2026Break

  UPON CONFIRMATION WITH SURGEON, THE COMPLAINT WAS WRONGLY NARRATED BY THE CLINIC MANAGER. THE INCIDENT WAS A SCRATCH MARK OBSERVED ON LENS OPTIC AFTER IMPLANTATION INTO THE EYE, SURGEON EXPLANTED AND INSERTED A NEW LENS IN THE INITIAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24401256 ↗
• MalfunctionFeb 12, 2026Failure to Fold

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING CATARACT PHACOEMULSIFICATION AND INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INJECTOR DOES NOT PROPERLY LOAD THE LENS, PREVENTING ITS IMPLANTATION DURING LOADING. THE PROCEDURE WAS COMPLETED USING ANOTHER LENS OF THE SAME TYPE WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24320684 ↗
• MalfunctionFeb 5, 2026Failure to Deliver

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE IOL BECAME STUCK IN THE INJECTOR DURING IMPLANTATION AND REQUIRED TO BE REPLACED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24268800 ↗
• MalfunctionJan 7, 2026Material Twisted/Bent

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE LENS DID NOT ADVANCE DURING PRIMING AFTER SCRUB NURSE HAS FILLED THE INJECTOR WITH RECOMMENDED VISCOELASTIC. SCRUB NURSE NOTED THAT THE TRAILING HAPTIC WAS KINKED. THERE WAS PATIENT CONTACT. THE PROCEDURE WAS COMPLETED WITH NEW LENS WITH NO COMPLICATIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23988025 ↗
• MalfunctionDec 31, 2025Failure to Advance; Scratched Material; Failure to Advance; Scratched Material

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DURING IOL IMPLANTATION, THE PISTON JUMPED OVER THE FRONT OF THE LENS, MOVED FORWARD, AND REACHED THE DISTANT HAPTIC, GETTING STUCK AT THE TIP IN BETWEEN. IT COULD NOT BE MOVED FORWARD OR BACKWARD. THE SYSTEM WAS DISMANTLED, AND THE IOL WAS SALVAGED AND IMPLANTED INTO THE EYE USING ANOTHER TECHNIQUE AS A USABLE MATERIAL. LENS WAS REMOVED DURING INITIAL PROCEDURE DUE TO SCRATCHES ON THE IOL. THERE WAS NO PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 23932511 ↗
• MalfunctionSep 15, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF HAPTIC DID NOT UNFOLD CORRECTLY. THE SUREGRY WAS COMPLETED WITH UNSPECIFIED REPLACEMENT IOL. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23052450 ↗
• MalfunctionAug 22, 2025Failure to Deliver; Failure to Deliver

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS DID NOT FULLY COME OUT OF THE INJECTOR. PART OF THE LENS GOT STUCK IN THE INJECTOR, AND THE OTHER PART WAS STUCK AT THE INCISION SITE. THE STUCK PART WAS REMOVED FROM THE INCISION. THE PROCEDURE WAS COMPLETED THE SAME DAY USING THE SAME MODEL, SAME DIOPTER, AND SAME COMPANY LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING AS PER THE SURGEON, THE PLUNGER AND LENS BECAME STUCK INSIDE THE CANNULA OPENING AND WOULD NOT ADVANCE. THE LENS AND CANNULA WERE WITHDRAWN WITHOUT ISSUE, AND A DIFFERENT INJECTOR AND LENS OF THE SAME POWER WERE USED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 22873735 ↗
• MalfunctionJul 23, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION, DEFECTIVE INTRA OCULAR LENS. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, LENS LOOP WAS STUCK IN THE INJECTOR. THE SURGERY WAS COMPLETED BY IMPLANTING A NEW IOL OF SAME MODEL AND POWER. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22576100 ↗
• MalfunctionJul 18, 2025Break; Failure to Fold; Material Twisted/Bent; Break; Failure to Fold; Material Twisted/Bent

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE LENS DID NOT LOAD CORRECTLY. WHEN THE SURGEON WAS ABOUT TO INJECT IT INTO THE EYE HE SPOTTED THAT THE LEADING HAPTIC WAS PROTRUDING FORWARD, AND NOT FOLDED OVER THE TOP OF THE LENS. THE MAIN ISSUE WAS THAT THE ROUNDED TIP OF THE HAPTIC WAS MISSING, RENDERING THE LENS UNUSABLE. THE INJECTOR WAS IN CONTACT WITH THE PATIENT, ABOUT TO BE INSERTED INTO THE INCISION IN THE CORNEA. ONCE THE FAULT WAS IDENTIFIED THE INJECTOR WAS IMMEDIATELY WITHDRAWN AND LENS WAS REPLACED WITH ANOTHER LENS, WHICH LOADED PERFECTLY. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. THERE WAS NO IMPACT TO PATIENT. THE MISSING TIP OF THE HAPTIC WAS DEFINITELY NOT IN THE EYE OF THE PATIENT, THE SURGEON HAD NOT BEGUN TO INJECT IT, HE SPOTTED THE FAULT AS SOON AS IT CAME INTO THE FIELD OF VISION OF THE MICROSCOPE, AS HE WAS ABOUT TO OFFER IT UP TO THE EYE. THE SURGEON COULD SEE IT IN THE INJECTOR. IT WAS ALSO NOT FOUND IN THE PACKAGING THAT THE LENS WAS IN. THERE WAS NO RESISTANCE OR ANYTHING TO INDICATE THAT THERE WAS A PROBLEM WHILE THE SCRUB PRACTITIONER WAS LOADING THE LENS. ADDITIONAL IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22547141 ↗
• MalfunctionJul 16, 2025Device Difficult to Setup or Prepare; Failure to Advance; Device Difficult to Setup or Prepare; Failure to Advance

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHILE INJECTING THE LENS, IT WAS OBSERVED THAT THE INJECTOR PISTON DID NOT ADVANCE AND THE LENS HAPTIC WAS JAMMED. SO, THE IMPLANTATION WAS ABORTED AND ANOTHER UNSPECIFIED LENS WAS IMPLANTED. THERE WAS NO IMPACT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22521318 ↗
• MalfunctionJul 9, 2025Break; Failure to Fold; Failure to Deliver; Failure to Advance; Break; Failure to Fold; Failure to Deliver; Failure to Advance

  A NURSE REPORTED WITH A DESCRIPTION OF LOADING ISSUE AND HAPTIC LEG BROKEN WITH NO PATIENT HARM. NO FURTHER INFORMATION EXPECTED AS REPORTER UNWILLING TO PROVIDE ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22455778 ↗
• MalfunctionJul 4, 2025Failure to Advance; Scratched Material; Failure to Advance; Scratched Material

  A PHYSICIAN REPORTED WITH A DESCRIPTION OF WHILE ASSEMBLING, THE INJECTOR PASSED OVER THE LENS, RESULTING IN SCRATCH. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22402179 ↗
• MalfunctionJul 1, 2025Scratched Material; Scratched Material

  A PHYSICIAN REPORTED WITH A DESCRIPTION OF THE INTRAOCULAR LENS(IOL) APPEARED SCRATCHED BEFORE INSERTION INTO THE ANTERIOR CHAMBER AND THEREFORE WAS NOT IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22372182 ↗
• MalfunctionJul 1, 2025Failure to Advance; Device Damaged by Another Device; Failure to Advance; Device Damaged by Another Device

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTICED THAT THE PLUNGER WENT OVER THE LENS, IT DAMAGED THE LENS POSTERIOR HAPTICS AND IT WAS NOT IN CONTACT WITH THE PATIENT. SO, THE SURGERY WAS COMPLETED WITH AN ANOTHER UNSPECIFIED LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22371955 ↗
• MalfunctionJun 30, 2025Material Twisted/Bent; Material Twisted/Bent

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, TRAILING HAPTIC TANGLED AROUND THE PLUNGER. THE LENS WAS ABLE TO BE INSERTED INTO THE PATIENTS EYE, THE PATIENT WAS NOT HARMED AND THERE WAS NO FURTHER MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22359474 ↗