AcrySof® UltraSert® AU00T0 (UDI 00380652394789)Recalls & reported problems

Summary

The FDA's MAUDE database contains 89 adverse event reports that list this exact device (DI 00380652394789), received between Mar 11, 2021 and Sep 30, 2026 — classified as 6 injuries, 83 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (21 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 89 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 7 of 7.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948065 ↗
• 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 3 of 7.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948032 ↗
• MalfunctionSep 26, 2026Device Difficult to Setup or Prepare

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50907627 ↗
• MalfunctionSep 26, 2026Device Difficult to Setup or Prepare

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50907619 ↗
• MalfunctionAug 17, 2026Failure to Deliver

  A Physician reported that during an intraocular lens (IOL) implant procedure, the IOL plunger incorrectly positioned the lens in the narrow section of the cartridge, resulting in entrapment and detachment of the haptic element as the lens exited the device. Provisc was used during both the system preparation stage and the implantation procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50280330 ↗
• MalfunctionAug 11, 2026Inaccurate Delivery

  A healthcare professional reported that during surgery, it was noted that the lens had been preloaded upside down. As a result, when the surgeon deployed the lens, it had to be flipped within the eye. There was no patient harm. However, if corrective action had not been taken, patient harm was considered likely. Additional information has been requested but is not available at the time of this report.This report was received via Regulatory agency.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50208152 ↗
• MalfunctionJul 29, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50064750 ↗
• MalfunctionMay 20, 2026Device Difficult to Setup or Prepare

  A HEALTH CARE PROFESSIONAL REPORTED WITH THE DESCRIPTION OF DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 25227375 ↗
• MalfunctionMar 30, 2026Failure to Deliver

  AN OPHTHALMIC SURGEON REPORTED THAT DURING CATARACT SURGERY INVOLVING INTRAOCULAR LENS (IOL) IMPLANTATION, THE LENS WAS STUCK AT THE PLUNGER. THERE WAS NO DAMAGE TO THE TRAILING HAPTIC, IT REMAINED INTACT AT THE END OF SURGERY. THE LENS REMAINS IMPLANTED. BASED ON THE ADDITIONAL INFORMATION PROVIDED, THE INCIDENT WAS ATTRIBUTED TO THE PRODUCT ITSELF, AND IT WAS NOTED THAT THE SURGEON WAS HIGHLY EXPERIENCED, HAVING PERFORMED THOUSANDS OF IOL IMPLANTATIONS.

  Patient problems: Insufficient Information

  MAUDE report 24712350 ↗
• MalfunctionMar 24, 2026Break; Device Difficult to Setup or Prepare; Failure to Deliver

  A PHYSICIAN REPORTED THAT DURING A CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL HAD BEEN STICKING TO THE INNER WALLS OF THE CARTRIDGE OF THE COMPANY¿S PRE LOADED SYSTEM. EVENTUALLY, THE TRAILING HAPTIC HAD BECOME STUCK BETWEEN THE TIP OF THE PLUNGER AND THE INNER WALL OF THE CARTRIDGE OF THE PRE LOADED DEVICE AND WAS CUT DURING IMPLANTATION. THE SURGEON DECIDED NOT TO EXCHANGE THE IOL. THE NEXT DAY, THE DOCTOR EXAMINED THE PATIENT AND REPORTED THAT THE IOL REMAINED IN THE TARGETED PLACE AND THE PATIENT HAD VERY GOOD VISION. THE PATIENT STATED THAT HE WAS VERY SATISFIED WITH THE VISUAL OUTCOMES. ALL THE CONDITIONS IN THE OPERATION ROOM AND THE HANDLING OF THE PRE LOADED IOL HAD BEEN ACCORDING TO SPECIFICATIONS AND GOOD PRACTICE GUIDELINES. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED BY STATING, THE IOL HAD BEEN STICKING TO THE INNER WALLS OF THE CARTRIDGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24673225 ↗
• MalfunctionMar 3, 2026Defective Device

  A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INJECTOR WAS DEFECTIVE AND BROKE THE HAPTICS. HAPTIC BROKE WHEN IT CAME OUT OF THE INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 24498334 ↗
• MalfunctionFeb 4, 2026Scratched Material

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A SCRATCH WAS NOTICED ON THE LENS OPTIC. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE, AND ANOTHER UNSPECIFIED LENS WAS IMPLANTED. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24257777 ↗
• MalfunctionJan 16, 2026Device Difficult to Setup or Prepare; Device Damaged by Another Device

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE NEEDLE WENT THROUGH THE LENS AND IT DAMAGED THE POSTERIOR HAPTIC AND AS A RESULT, IT WAS NOT INSERTED. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ANOTHER UNSPECIFIED LENS. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24093173 ↗
• MalfunctionJan 13, 2026Failure to Fold; Failure to Advance; Device Damaged by Another Device

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS DID NOT FOLD PROPERLY. THE BAT PASSED OVER THE LENS AND CRUSHED IT SO BADLY THAT IT COULD NOT BE USED OR REFOLDED INTO THE CARTRIDGE. THE SURGERY WAS COMPLETED ON SAME DAY. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24051979 ↗
• MalfunctionJan 3, 2026Failure to Deliver; Failure to Advance

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED THAT THE PLUNGER GOT STUCK WHICH DIDN¿T DIRECTLY AFFECT A PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT PROCEDURE WAS COMPLETED ON THE SAME DAY WITH THE ALTERNATE LENS. EVENT OCCURRED FOLLOWING PRIMING AS THE SURGEON WAS PREPARING FOR INSERTION. THE SURGEON MADE CONTACT WITH THE PATIENT EYE READY FOR THE IMPLANT BUT WAS UNABLE TO PROCEED AS THE LENS WAS STUCK IN THE PLUNGER. SURGEON STATED HE WAS UNABLE TO MOVE THE PLUNGER FORWARD AND FELT THERE WAS A MISPLACEMENT WITH THE ALIGNMENT.

  Patient problems: Insufficient Information

  MAUDE report 23952967 ↗
• MalfunctionJan 1, 2026Failure to Advance; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IOL FAILED/ FAULTY. THE FAULT WAS NOTICED PRIOR TO IMPLANT SO THERE WAS NO IMPACT TO THE PATIENT'S TREATMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DURING IOL INSERTION, THE LENS FAILED TO FOLD CORRECTLY WITHING THE INJECTOR CARTRIDGE. THE INJECTOR WAS PREPARED AND PRIMED AS PER MANUFACTURING INSTRUCTIONS USING COMPANY VISCOELASTIC AT ROOM TEMPERATURE. PRIMING PROCESS WAS PERFORMED SLOWLY COUNTING TO 7 SECONDS TO ENSURE SMOOTH LOADING OF THE LENS. DESPITE THIS PROCESS BEING FOLLOWED THE PLUNGER OVERRIDDEN THE TRAILING HAPTIC OF THE LENS RESULTING IN INCORRECT FOLDING OF THE LEADING HAPTIC OF THE LENS AS WELL MADE IT IMPOSSIBLE TO INSERT THE LENS. THE SURGERY WAS COMPLETED USING A DIFFERENT LENS. THERE WAS NO PATIENT CONTACT WITH THE FAULTY LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23941046 ↗
• MalfunctionJan 1, 2026Failure to Prime; Failure to Advance; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IOL FAILED/ FAULTY. THE FAULT WAS NOTICED PRIOR TO IMPLANT SO THERE WAS NO IMPACT TO THE PATIENT'S TREATMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DURING IOL INSERTION, THE LENS FAILED TO FOLD CORRECTLY WITHING THE INJECTOR CARTRIDGE. THE INJECTOR WAS PREPARED AND PRIMED AS PER MANUFACTURING INSTRUCTIONS USING COMPANY VISCOELASTIC AT ROOM TEMPERATURE. PRIMING PROCESS WAS PERFORMED SLOWLY COUNTING TO 7 SECONDS TO ENSURE SMOOTH LOADING OF THE LENS. DESPITE THIS PROCESS BEING FOLLOWED THE PLUNGER OVERRIDDEN THE TRAILING HAPTIC OF THE LENS RESULTING IN INCORRECT FOLDING OF THE LEADING HAPTIC OF THE LENS AS WELL MADE IT IMPOSSIBLE TO INSERT THE LENS. THERE WAS ALSO A SIGNIFICANT RESISTANCE DURING INJECTION, AND THE PLUNGER MOVEMENT WAS STIFF, WHICH LEAD TO PLUNGER DISPLACE. THE SURGERY WAS COMPLETED USING A DIFFERENT LENS. THERE WAS NO PATIENT CONTACT WITH THE FAULTY LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23938868 ↗
• MalfunctionDec 19, 2025Device Difficult to Setup or Prepare; Material Twisted/Bent; Device Difficult to Setup or Prepare; Material Twisted/Bent

  BASED ON NEW INFORMATION RECEIVED, THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23848734 ↗
• MalfunctionDec 8, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE LENS FOUND TO BE FAULTY (HAPTIC TRAILING UNSPECIFIED). THERE WAS NO PATIENT CONTACT WITH THE DEVICE. THE SURGERY WAS COMPLETED WITH REPLACEMENT IOL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23743003 ↗
• MalfunctionNov 14, 2025Device Damaged by Another Device; Device Damaged by Another Device

  A PHYSICIAN REPORTED THAT DURING SURGERY, THEY NOTICED THAT THE LENS WAS BROKEN. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23552137 ↗
• MalfunctionNov 12, 2025Break; Break

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS FOUND TO BE BROKEN. THERE WAS NO PATIENT CONTACT AND NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23534329 ↗
• MalfunctionNov 6, 2025Device Damaged by Another Device; Device Damaged by Another Device

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS FOUND TO BE BROKEN. THE PRODUCT WAS NOT APPLIED TO THE PATIENT, AND THE ISSUE WAS IDENTIFIED AFTER THE PRODUCT WAS OPENED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23484597 ↗
• MalfunctionSep 19, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  A NON-HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) TRAILING HAPTIC WRAPPED AROUND PLUNGER. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE LENS WAS INSERTED USING UNSPECIFIED FORCEPS. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23095041 ↗
• MalfunctionSep 18, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) HAPTIC UNDER LENGTH. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THERE WAS NO PATIENT CONTACT AND EVENT HAPPENED DURING LOADING THE LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23085976 ↗
• MalfunctionAug 26, 2025Failure to Deliver; Failure to Deliver

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS CANNOT BE ADVANCED AND INJECTOR WAS JAMMED. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22893742 ↗