AcrySof® UltraSert® ACU0T0 (REF ACU0T0.195)Recalls & reported problems
Alcon Laboratories, Inc. · Sterile UV and Blue Light Filtering Acrylic Foldable Single-Piece Posterior Chamber Lenses with the UltraSert® Pre-loaded Delivery System · Class 3 · Implant
All models of AcrySof UltraSert (102)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Alcon AcrySof UltraSert intraocular lens is implanted in the eye using a preloaded delivery system. The 23 reports mostly describe the lens or injector not advancing correctly, with parts bending or twisting and the lens becoming difficult or impossible to deploy. They include no deaths and 1 injury; no recalls name this device. Reports fell from 10 in the previous 12 months to 3 in the latest 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 24
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00380652395243), received between Mar 2, 2021 and Sep 30, 2026 — classified as 1 injury, 23 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (9 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.
Reports received per month
Most reported problems
Device problems
- Failure to Advance9
- Defective Device5
- Defective Component3
- Device Damaged by Another Device3
- Device Difficult to Setup or Prepare3
- Failure to Eject2
- Material Twisted/Bent2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Insufficient Information12
- No Clinical Signs, Symptoms or Conditions12
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Device Difficult to Setup or Prepare
A healthcare professional reported that during an intraocular lens (IOL) implantation procedure, the lens was very stiff to push while advancing the plunger. As a result, the lens was not used, although it had patient contact. The surgery was completed on the same day using another lens, without any harm to the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946538 ↗MalfunctionJun 9, 2026Failure to Advance
A FACILITY REPRESENTATIVE REPORTED STATING THAT THE PLUNGER ON THIS PRELOADED IOL FAILED TO ENGAGE THE LENS OPTIC AND INSTEAD PASSED OVER THE TOP OF IT. CONSEQUENTLY, THE LENS COULD NOT BE SAFELY DEPLOYED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25438741 ↗MalfunctionMar 13, 2026Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS TWISTED INSIDE THE INJECTOR. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION WAS RECEIVED BY STATING, ANOTHER UNSPECIFIED LENS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24588084 ↗MalfunctionNov 9, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS DIFFICULT TO REMOVE (DELIVERY-RELATED ISSUES) AND COULD NOT BE USED. ADDITIONAL INFORMATION RECEIVED STATING THAT THE TRAILING HAPTIC DELIVERED FIRST, THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23507021 ↗MalfunctionAug 29, 2025Failure to Advance; Failure to Advance
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PLUNGER WAS BENT AND OVERRIDES THE LENS. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22921875 ↗MalfunctionJun 16, 2025Material Twisted/Bent; Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED THAT BEFORE INTRAOCULAR LENS IMPLANT PROCEDURE THE SURGEON NOTICED THE INTRAOCULAR LENS HAPTIC DEFORMED OR ASYMMETRIC. THERE WAS NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED WITH BACK UP LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22210605 ↗MalfunctionMay 30, 2025Failure to Advance; Failure to Advance
A HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INTRODUCER OVERSHOT THE PREPARED LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22112123 ↗MalfunctionApr 30, 2025Defective Device; Defective Device
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF DEFECTIVE INTRAOCULAR LENS (IOL) DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21935707 ↗MalfunctionApr 1, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC EXITS THE LENS INTRODUCER AT AN UNUSUAL ANGLE. THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21740280 ↗MalfunctionMar 24, 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 21675886 ↗MalfunctionFeb 18, 2025Crack; Crack
A NON-HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION THAT, DEFECTIVE LENS WAS IMPLANTED. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, SMALL CRACK AT THE PLATE-LOOP JUNCTION OF THE IOL (PROXIMAL HAPTIC). THE DEFECT DID NOT AFFECT THE FUNCTION, STABILITY AND SAFETY OF THE IOL AND SO IT WAS DECIDED TO LEAVE IT IN SITU. AT THE POST-OPERATIVE CHECK THE PATIENT DID NOT REPORT ANY ALTERATIONS.
Patient problems: Insufficient Information
MAUDE report 21395966 ↗MalfunctionJan 6, 2025Defective Component; Failure to Advance; Device Damaged by Another Device; Defective Component; Failure to Advance; Device Damaged by Another Device
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF ON PREPPING THE INTRAOCULAR LENS AND ADVANCING THE SYRINGE AS USUAL, FELT SCRATCHY AND COULD NOT SEE THE LEADING HAPTIC. COULD NOT VISIBLY DETECT A LENS IN THE CARTRIDGE. NO PATIENT CONTACT AND NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21078369 ↗MalfunctionNov 28, 2024Device Damaged by Another Device; Failure to Eject; Device Damaged by Another Device; Failure to Eject
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, PLUNGER WENT OVER THE LENS OR PLUNGER OVER RIDE OR PLUNGER BY PASSED THE IOL AND DID NOT DEPLOY AND LENS WAS DAMAGED DUE TO PLUNGER RUN OVER TOP OF LENS INSTEAD OF PUSHING THE LENS OUT. ADDITIONAL INFORMATION WAS REQUESTED. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 3.
Patient problems: Insufficient Information
MAUDE report 20805036 ↗MalfunctionNov 7, 2024Defective Device; Defective Device
A HEALTHCARE PROFESSIONAL REPORTED WITH THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE NURSE WAS NOT ABLE TO FILL THE CHAMBER OF THE CARTRIDGE WITH VISCOELASTIC. THE CHAMBER WAS BLOCKED. BUT THE VISCOELASTIC KEPT COMING OUTSIDE THROUGH THE INLET. THE SURGERY COMPLETED WITH BACKUP LENS. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20635044 ↗MalfunctionJul 11, 2024Failure to Advance; Failure to Advance
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THE INTRAOCULAR LENSES (IOLS) WOULD NOT DEPLOY AFTER BEING PREPARED SO THEY HAD TO BE DISCARDED DUE TO BEING CONTAMINATED. THE SURGERY WAS COMPLETED USING NEW IOL. REPORTER HAS NO FURTHER INFORMATION TO PROVIDE.
Patient problems: Insufficient Information
MAUDE report 19718872 ↗MalfunctionJul 11, 2024Failure to Advance; Failure to Advance
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THE INTRAOCULAR LENSES (IOLS) WOULD NOT DEPLOY AFTER BEING PREPARED SO THEY HAD TO BE DISCARDED DUE TO BEING CONTAMINATED. THE SURGERY WAS COMPLETED USING NEW IOL. REPORTER HAS NO FURTHER INFORMATION TO PROVIDE.
Patient problems: Insufficient Information
MAUDE report 19718871 ↗MalfunctionJul 11, 2024Failure to Advance; Failure to Advance
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THE INTRAOCULAR LENSES (IOLS) WOULD NOT DEPLOY AFTER BEING PREPARED SO THEY HAD TO BE DISCARDED DUE TO BEING CONTAMINATED. THE SURGERY WAS COMPLETED USING NEW IOL. REPORTER HAS NO FURTHER INFORMATION TO PROVIDE.
Patient problems: Insufficient Information
MAUDE report 19718870 ↗MalfunctionJun 28, 2024Defective Component; Defective Component
A FACILITY REPRESENTATIVE REPORTED THAT THE PLUNGER WAS DEFECTIVE. SOMETHING DIDN'T DEPLOY CORRECTLY. PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19632158 ↗MalfunctionAug 9, 2023Defective Component; Defective Device; Device Damaged by Another Device; Defective Component; Defective Device; Device Damaged by Another Device
A PHYSICIAN REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PLUNGER GOT STUCK AND CRACKED THE LENS, THE LEADING HAPTIC WAS TWISTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17490965 ↗MalfunctionAug 2, 2023Defective Device; Defective Device
A NURSING CHIEF REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL CAME DEFECTIVE INTO THE EYE DURING IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE ELEVEN MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS REPORT IS FOR NINE OF ELEVEN.
Patient problems: Insufficient Information
MAUDE report 17441672 ↗InjuryJun 22, 2022Defective Device; Difficult to Advance; Device Dislodged or Dislocated; Defective Device; Difficult to Advance; Device Dislodged or Dislocated
A PHYSICIAN REPORTED WITH A DESCRIPTION OF FAULTY INTRAOCULAR LENS (IOL) WAS REPORTED, ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, ON EVALUATION OF THE EYE POST-OPERATIVELY, IT WAS NOTED THAT THE LENS HAS SHIFTED FROM THE BAG DUE TO FAULTY HAPTIC AND THERE WAS NO LONGER IN POSITION. ONE MONTH OF INITIAL IMPLANT THE IOL WAS REPOSITIONED SUCCESSFULLY. THE PHYSICIAN MENTIONED THAT, THE ISSUE IS WITH THE INJECTOR, NOT THE LENS ITSELF. THE LENS COME OUT TWISTED FROM THE INJECTOR ALMOST ALL THE TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14770620 ↗MalfunctionDec 28, 2021Failure to Advance; Failure to Advance
A NURSE REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PLUNGER OF DELIVERY SYSTEM GOT STUCK. THERE WAS A PATIENT CONTACT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13092573 ↗MalfunctionNov 24, 2021Failure to Eject; Failure to Eject
A NURSE REPORTED DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION THE PLUNGER WENT OVER THE LENS. THERE WAS PATIENT CONTACT AND THE SURGERY WAS DELAYED FOR ONE MINUTE AND WAS COMPLETED WITH NO OTHER PROBLEMS BY USING A BACK UP LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12870732 ↗MalfunctionMar 2, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A CUSTOMER REPORTED A PRELOADED INTRAOCULAR LENS (IOL) DELIVERY SYSTEM WITH A FAULTY LENS. ADDITIONAL INFORMATION WAS RECEIVED CLARIFYING THAT THE NOZZLE OF THE PRELOADED DEVICE WAS MISSING. THERE WAS NO REPORTED PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11400904 ↗
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- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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