AcrySof® UltraSert® ACU0T0 (REF ACU0T0.230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00380652395311), received between Mar 29, 2021 and May 11, 2026 — classified as 6 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2026Failure to Advance; Device Damaged by Another Device

  A HEALTH CARE PROFESSIONAL REPORTED THAT BEFORE THE INTRAOCULAR LENS (IOL) STAMP OF THE INJECTOR HAS PIERCED THE LENS. IT WAS ALSO REPORTED THAT THE LENS STUCK IN THE SHOOTER, DESPITE OVD AND WAS PIERCED BY THE STAMP OF THE SHOOTER, ALL WHILE HANDING IT TO THE SURGEON. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE SURGERY DURATION HAS NOT INCREASED SIGNIFICANTLY. A BACKUP IOL WAS USED. THERE WAS NO PATIENT CONTACT AND NO IMPACT TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25137416 ↗
• MalfunctionApr 4, 2026Device Damaged by Another Device

  A NON-HEALTHCARE PROFESSIONAL STATED HAPTIC BROKEN/MISSING/DEFORMED. THERE WAS PATIENT CONTACT BUT NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE HAPTIC WAS BROKEN NOTED UPON OPENING. SURGERY WAS COMPLETED USING THE BACKUP LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24784361 ↗
• MalfunctionNov 7, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE TRAILING HAPTIC WAS DELIVERED FIRST. THE LENS WAS UNABLE TO BE USED. ADDITIONAL INFORMATION RECEIVED STATING THAT THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23503705 ↗
• MalfunctionNov 7, 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, IT WAS FOUND TO BE DIFFICULT TO REMOVE LENS. THE LENS HAD DELIVERY-RELATED ISSUES. FORTUNATELY, SURGEON WAS ABLE TO OVERCOME WITHOUT THE NEED FOR ADDITIONAL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE LENS TRAILING HAPTIC WAS DELIVERED FIRST. THE IOL WAS IMPLANTED WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23496262 ↗
• MalfunctionSep 11, 2025Device Difficult to Setup or Prepare; Inaccurate Delivery; Device Difficult to Setup or Prepare; Inaccurate Delivery

  A HEALTH CARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS CAME OUT OF THE INJECTOR WITH THE LEADING HAPTIC, CAUSING IMPROPER DELIVERY. THE PROCEDURE WAS PROLONGED. MULTIPLE UNSPECIFIED LENSES WERE NEEDED DUE TO REPEATED ISSUES. EXTRA VISCOELASTIC MATERIAL WAS ALSO USED. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23026157 ↗
• InjurySep 2, 2025Break; Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, ONE OF THE HAPTICS BROKE OFF AS SURGEON WAS INSERTING THE IOL, THE HAPTIC WAS MISSING, FOUND IN THE INJECTOR. THE SURGERY WAS COMPLETED WITH UNSPECIFIED REPLACEMENT IOL. ADDITIONAL INFORMATION RECEIVED STATING THAT COMPLAINT STARTED ON (B)(6) 2025 AND SURGERY WAS COMPLETED ON (B)(6) 2025.

  Patient problems: Insufficient Information

  MAUDE report 22939081 ↗
• MalfunctionAug 11, 2025Break; Device Difficult to Setup or Prepare; Break; Device Difficult to Setup or Prepare

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) PROCEDURE, THE HAPTIC WAS BROKEN AT TIME OF ATTEMPTED DELIVERY INTO THE EYE. THE LENS INJECTION SYSTEM WAS POOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22773251 ↗
• InjuryAug 1, 2025Device Damaged by Another Device; Device Damaged by Another Device

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION SURGERY, UPON ATTEMPTING TO INSERT LENS SURGEON NOTICED THAT THE LENS HAPTIC WAS BROKEN/ MISSING AND IT WAS ASSUMED THAT LENS WAS FAULTY OR LEFT INSIDE THE INJECTOR. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS DURING INITIAL PROCEDURE AND SUTURES WAS USED. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY FURTHER HARM TO THE PATIENT AND THE FAULTY LENS WAS DISCARDED. THE SURGEON STATED THAT THE PATIENT WAS MONITORED TO CONFIRM PATIENT WAS NOT AFFECTED BY INCIDENT AND THE STITCHES WAS REMOVED IN A WEEK. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT THERE WAS NO FURTHER IMPACT TO THE PATIENT.

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

  MAUDE report 22686229 ↗
• InjuryJul 3, 2025Inaccurate Delivery; Inaccurate Delivery

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT BECAME DIFFICULT TO INJECT THE LENS WITHIN THE PRELOAD DELIVERY DEVICE. THE SURGEON HAD TO APPLY MORE PRESSURE, RESULTING IN THE LENS TO OVERSHOT THE CAPSULE AND ENTER PARTIALLY BEHIND THE EYE CAPSULE. WHICH CAUSED RUPTURE OF THE CAPSULE BAG INTO THE VITREOUS CAVITY. THE LENS WAS REMOVED AND SURGEON PERFORMED AN ANTERIOR VITRECTOMY AND SUTURED THE CORNEA. THE SURGERY WAS COMPLETED WITHOUT THE LENS. THE PATIENT HAD POOR VISION BECAUSE OF APHAKIA POST-PROCEDURE. REFERRED TO OTHER SURGICAL TEAM. THE PATIENT IS CURRENTLY ON THE WAITING LIST TO HAVE SECONDARY IOL IMPLANT WITH THEM.

  Patient problems: Capsular Bag Tear

  MAUDE report 22393978 ↗
• MalfunctionMay 27, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF HAPTIC PART OF THE INTRAOCULAR LENS (IOL) WAS DAMAGED. EVENT OCCURRED BEFORE SURGERY AND THERE WAS NO PATIENT CONTACT OR IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22085544 ↗
• MalfunctionMay 20, 2025Failure to Advance; Failure to Advance

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE PRIOR TO INSERTION, IT WAS NOTED THAT THE INJECTOR HAD BYPASSED THE LENS. THE ISSUE CAUSED A 2 MINUTE DELAY TO THE PROCEDURE. THE SURGERY COMPLETED WITH UNSPECIFIED BACK UP LENS. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22052505 ↗
• MalfunctionMay 5, 2025Failure to Fold; Failure to Fold

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENSES WOULD NOT LOAD. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21961570 ↗
• MalfunctionMay 5, 2025Failure to Fold; Failure to Fold

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENSES WOULD NOT LOAD. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21961567 ↗
• MalfunctionApr 22, 2025Break; Break

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE LENS HAPTIC WAS BROKEN IN DELIVERY SYSTEM. THE LENS HAPTIC (LEADING) DETACHED FROM IOL ON ATTEMPT AT INSERTION· THE LENS AND INTRODUCER WERE THEN REMOVED AND FORCEPS USED TO RETRIEVE THE HAPTIC. THE PROCEDURE WAS COMPLETED WITH REPLACEMENT LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21880555 ↗
• MalfunctionApr 4, 2025Material Deformation; Material Deformation

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT THE INJECTOR NOZZLE TIP LARGER THAN NORMAL AND NOT ABLE TO INTRODUCE EVEN AFTER TUNNEL ENLARGEMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21774575 ↗
• MalfunctionMar 26, 2025Failure to Advance; Failure to Advance

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS PRIMED WITH VISCOELASTIC AS PER GUIDELINES, PLUNGER WAS PUSHED BUT IT DID NOT ENGAGE WITH THE LENS AND WENT UNDER THE LENS. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THE SURGERY WAS COMPLETED USING REPLACEMENT LENS.

  Patient problems: Insufficient Information

  MAUDE report 21698543 ↗
• MalfunctionMar 21, 2025Failure to Advance; Failure to Advance

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY WHILE TRYING TO LOAD THE LENS, THE BLUE PLUNGER DID NOT ENGAGE WITH THE LENS WITHIN THE PRE-LOADED DELIVERY SYSTEM, WHILST THE BLUE PLUNGER DID ADVANCE, THE LENS REMAINED IN THE BODY OF THE DELIVERY SYSTEM. THE SURGERY WAS ABLE TO CONTINUE BY A NEW UNSPECIFIED LENS OF THE SAME DIOPTER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21664447 ↗
• MalfunctionMar 21, 2025Failure to Advance; Failure to Advance

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY WHILE TRYING TO LOAD THE LENS, THE BLUE PLUNGER DID NOT ENGAGE WITH THE LENS WITHIN THE PRE-LOADED DELIVERY SYSTEM, WHILST THE BLUE PLUNGER DID ADVANCE, IT WAS VERY STIFF TO LOAD, IT WAS HIGHLIGHTED TO THE SURGEON, THE SURGEON AGREED AND IT WAS NOT USED AS IT COULD NOT BE ADVANCED. THE SURGERY WAS ABLE TO CONTINUE BY A NEW LENS OF THE SAME DIOPTER. ADDITIONAL INFORMATION HAS RECEIVED AND IT STATES THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21663972 ↗
• MalfunctionFeb 25, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  A HEALTH CARE PROFESSIONAL REPORTED THAT LENS TRAILING HAPTIC WAS NOT ENGAGED AND THERE WILL BE A POSSIBILITY THAT IT WILL SNAP ONCE INSERTED. NO PATIENT CONTACT WITH THE LENS. ADDITIONAL INFORMATION HAS RECEIVED AND IT STATES THAT NO PATIENT IMPACT WAS REPORTED AND SURGERY ABLE TO BE COMPLETED WITH DIFFERENT LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21457138 ↗
• MalfunctionJan 17, 2025Break; Defective Device; Break; Defective Device

  A HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, UPON INSERTION OF THE IOL, FAULTY AND WOULD NOT DISCHARGE CORRECTLY. THE HAPTIC WAS LEFT BEHIND IN THE INTRODUCER; SURGEON FELT ABLE TO POSITION THE LENS WITH THE ONE REMAINING HAPTIC, HOWEVER, THIS ALSO THEN BECAME DETACHED AND THE LENS HAD TO BE REMOVED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITH AN ALTERNATIVE LENS WITHOUT ANY HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21180692 ↗
• MalfunctionJan 13, 2025Failure to Fold; Failure to Prime; Failure to Advance; Difficult to Advance; Failure to Eject; Failure to Fold; Failure to Prime; Failure to Advance; Difficult to Advance; Failure to Eject

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY THE LENS WOULD NOT LOAD OR ADVANCE DUE TO THE BLUE PLASTIC INSERT BYPASSING THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 21138087 ↗
• MalfunctionJan 13, 2025Failure to Fold; Failure to Prime; Failure to Advance; Difficult to Advance; Failure to Eject; Failure to Fold; Failure to Prime; Failure to Advance; Difficult to Advance; Failure to Eject

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY THE LENS WOULD NOT LOAD OR ADVANCE DUE TO THE BLUE PLASTIC INSERT BYPASSING THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 21138015 ↗
• MalfunctionJan 13, 2025Failure to Fold; Failure to Prime; Failure to Advance; Difficult to Advance; Failure to Eject; Failure to Fold; Failure to Prime; Failure to Advance; Difficult to Advance; Failure to Eject

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY THE LENS WOULD NOT LOAD OR ADVANCE DUE TO THE BLUE PLASTIC INSERT BYPASSING THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 21137951 ↗
• MalfunctionJan 13, 2025Failure to Fold; Failure to Prime; Failure to Advance; Difficult to Advance; Failure to Eject; Failure to Fold; Failure to Prime; Failure to Advance; Difficult to Advance; Failure to Eject

  ADDITIONAL INFORMATION HAS RECEIVED AND IT STATES THAT UPON PRIMING, THE BLUE THING INSIDE THE CARTRIDGE KEEPS BENDING, SO THE LENS CANNOT BE PUSHED STRAIGHT TO PROPERLY PRIME. SURGERY ABLE TO BE COMPLETED BY THE STAFF BUT HAD TO OPEN MULTIPLE LENSES AS IT KEPT HAPPENING ON THE NEW FEW LENSES THEY HAVE OPENED. ON THE 5TH LENS, SCRUB NURSE MANAGED TO HAVE IT PRIMED PROPERLY. THERE IS NO PATIENT CONTACT. NO PATIENT IMPACT WAS REPORTED.

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

  MAUDE report 21137867 ↗
• MalfunctionAug 27, 2024Defective Device; Defective Device

  A HEALTH CARE PROFESSIONAL REPORTED FOUR DEFECTIVE PRODUCTS. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20073982 ↗