AcrySof® UltraSert® ACU0T0 (REF ACU0T0.235)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 is a foldable intraocular lens used to replace the eye's natural lens during cataract surgery. The 27 reports mostly describe the lens or its preloaded injector failing to deliver properly during surgery: the lens getting stuck, jammed or twisted in the injector, a broken haptic, or a plunger that would not advance. Reports mention 1 injury and no deaths, and no recalls name this device.
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
- 27
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00380652395328), received between Jun 30, 2021 and May 8, 2026 — classified as 1 injury, 26 malfunctions.
The most frequently reported specific device problem is “Device Damaged by Another Device” (8 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
- Device Damaged by Another Device8
- Failure to Advance7
- Defective Device5
- Failure to Deliver4
- Scratched Material4
- Failure to Eject3
- Device Difficult to Setup or Prepare2
- Material Twisted/Bent2
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- Insufficient Information12
- Capsular Bag Tear1
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2026Device Damaged by Another Device
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS DISCOVERED THAT THE INTENDED INTRAOCULAR LENS SELECTED FOR IMPLANTATION WAS DAMAGED. WHILE THE INTRAOCULAR LENS WAS BEING INJECTED, THE SURGEON AND SCRUB NURSE OBSERVED THAT THE TRAILING HAPTIC WAS BROKEN WITHIN THE DELIVERY SYSTEM. IT WAS ALSO REPORTED THAT THE LENS WAS REMOVED AND A NEW LENS WAS SUCCESSFULLY IMPLANTED. THE CATARACT SURGERY WAS COMPLETED WITHOUT COMPLICATION AND THE PATIENT WAS NOT ADVERSELY AFFECTED. 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 25123905 ↗MalfunctionApr 8, 2026Failure to Deliver
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED THAT THE LENS DID NOT ENGAGE. THERE WAS NO PATIENT HARM. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH A NEW UNSPECIFIED LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24817403 ↗MalfunctionMar 26, 2026Failure to Deliver; Device Damaged by Another Device
A NURSE REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THEY NOTICED THE LENS BECAME JAMMED IN THE INJECTOR AND IT WAS DAMAGED, WHICH MADE ITS IMPLANTATION IMPOSSIBLE. UNSPECIFIED REPLACEMENT LENS WAS USED. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24699437 ↗MalfunctionDec 30, 2025Material Twisted/Bent; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE TRAILING HAPTIC FOUNT TO BE TWISTED. THERE WAS NO IMPACT TO THE PATIENT. THE SURGERY WAS COMPLETED ON THE SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23923028 ↗MalfunctionNov 14, 2025Failure to Advance; Failure to Advance
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT AND INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHILE INJECTING, THE PLUNGER OVERRODE THE LENS. THERE WAS NO ISSUE WITH THE LEADING OR TRAILING HAPTIC AND THERE WAS PATIENT CONTACT. NO MEDICAL INTERVENTION WAS REQUIRED AND THE PATIENT WAS NOT HOSPITALIZED AS A RESULT OF THIS EVENT. THE DEVICE WAS MAINTAINED BETWEEN 18 DEGREES CELSIUS (64 DEGREES FAHRENHEIT) AND 23 DEGREES CELSIUS (73 DEGREES FAHRENHEIT) AT OPERATING ROOM TEMPERATURES AFTER BEING ALLOWED TO ACCLIMATE FOR AT LEAST 30 MINUTES. THE PROCEDURE WAS COMPLETED ON THE SAME DAY USING A DIFFERENT LENS WITHOUT ANY HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23555989 ↗MalfunctionJun 13, 2025Failure to Advance; Failure to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF THE PLUNGER FAILED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22203197 ↗MalfunctionMay 26, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22084705 ↗MalfunctionMay 6, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A PHYSICIAN REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THAT WHILE THE INJECTION OF THE IOL IN THE EYE OF A PATIENT, THE PROXIMAL LOOP OF THE IOL WAS STUCK IN THE INJECTOR, TWISTED AND REMAINED PERMANENTLY DISTORTED. THE PROBLEM WAS IDENTIFIED BEFORE THE IOL WAS COMPLETELY INJECTED INTO THE PATIENT EYE. SINCE THE LOOP WAS PERMANENTLY CROOKED (AND COULD NOT BE STRAIGHTENED WITH INSTRUMENTS), A SECOND IOL WAS OPENED AND INJECTED INTO PATIENT EYE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21970266 ↗MalfunctionMar 18, 2025Failure to Advance; Scratched Material; Failure to Advance; Scratched Material
A PHYSICIAN REPORTED WITH A DESCRIPTION OF INJECTOR PASSED OVER THE LENS WITHOUT HOOKING IT BUT SCRATCHING IT. THE PROCEDURE COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21629960 ↗MalfunctionMar 18, 2025Failure to Advance; Material Twisted/Bent; Failure to Advance; Material Twisted/Bent
A PHYSICIAN REPORTED WITH A DESCRIPTION OF WHEN LOADING THE LENS, THE PISTON WAS SLIDING WITH DIFFICULTY. INSTEAD OF MOVING STRAIGHT, SHIFTED UPWARD AND TO THE RIGHT, LENS WAS TANGLED AND LEAVING THE SECOND LOOP BEHIND. THE PROCEDURE COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21629956 ↗MalfunctionNov 20, 2024Failure to Deliver; Failure to Eject; Failure to Deliver; Failure to Eject
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS IMPLANTED INTO THE EYE WHEN THE DOCTOR WAS POSITIONING THE LENS AND NOTICED A SCRATCH. THE LENS WAS REMOVED. THE SECOND AND THIRD LENS WERE JAMMED IN THE CARTRIDGE. THE FOURTH LENS WAS IMPLANTED SUCCESSFULLY.
Patient problems: Insufficient Information
MAUDE report 20737791 ↗MalfunctionNov 20, 2024Failure to Deliver; Failure to Eject; Failure to Deliver; Failure to Eject
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS IMPLANTED INTO THE EYE WHEN THE DOCTOR WAS POSITIONING THE LENS AND NOTICED A SCRATCH. THE LENS WAS REMOVED. THE SECOND AND THIRD LENS WERE JAMMED IN THE CARTRIDGE. THE FOURTH LENS WAS IMPLANTED SUCCESSFULLY.
Patient problems: Insufficient Information
MAUDE report 20736212 ↗MalfunctionNov 20, 2024Device Damaged by Another Device; Scratched Material; Device Damaged by Another Device; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS IMPLANTED INTO THE EYE WHEN THE DOCTOR WAS POSITIONING THE LENS AND NOTICED A SCRATCH. THE LENS WAS REMOVED. THE SECOND AND THIRD LENS WERE JAMMED IN THE CARTRIDGE. THE FOURTH LENS WAS IMPLANTED SUCCESSFULLY.
Patient problems: Insufficient Information
MAUDE report 20736058 ↗MalfunctionAug 9, 2024Failure to Eject; Failure to Eject
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY HAD A PROBLEM WITH THE COMPANY PRE-LOADED LENS WHEN TRYING TO PRIME IT. USED THE CORRECT AMOUNT OF VISCOELASTIC AS DIRECTED TO PRIME THE LENS BUT ON PUSHING THE PLUNGER FORWARD, THE BLUE ADVANCER MISSED THE IOL AND THE LENS REMAINED IN THE CHAMBER (AS CONFIRMED BY THE SURGEON VIA MICROSCOPE). THERE WAS NO PATIENT HARM AND WAS ABLE TO PROCEED AS WE USED AN ALTERNATIVE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19947685 ↗InjuryMay 13, 2024Inaccurate Delivery; Inaccurate Delivery
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS WAS SHOT OUT AND CAUSED A SPLIT IN THE ANTERIOR CAPSULE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Capsular Bag Tear
MAUDE report 19296918 ↗MalfunctionMar 15, 2024Defective Device; Defective Device
A HEALTH PROFESSIONAL REPORTED A FAULTY DEVICE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED. THE DEVICE WAS NOT USED.
Patient problems: Insufficient Information
MAUDE report 18913681 ↗MalfunctionAug 4, 2023Failure to Advance; Failure to Advance
A HEALTH CARE PROFESSIONAL REPORTED THAT, DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL STUCK IN THE PLUNGER, CANNOT BE REMOVED FROM THE PLUNGER. THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17459543 ↗MalfunctionAug 4, 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE ELEVEN MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS REPORT IS FOR 5 OF 11.
Patient problems: Insufficient Information
MAUDE report 17456620 ↗MalfunctionAug 2, 2023Defective Device; Defective Device
A HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INTRAOCULAR LENS CAME DEFECTIVE INTO THE EYE DURING IMPLANTATION. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17441180 ↗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 EIGHT OF ELEVEN.
Patient problems: Insufficient Information
MAUDE report 17441027 ↗MalfunctionApr 20, 2023Device Damaged by Another Device; Device Damaged by Another Device
A OTHER HEALTH CARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THE LENS WAS CRACKED AND THE LENS HAD TO BE CUT OUT AND ANOTHER LENS HAD TO BE IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THERE WAS NO DIRECT HARM TO THE PATIENT BUT THE SURGERY WAS PROLONGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16776153 ↗MalfunctionMar 24, 2023Failure to Advance; Device Damaged by Another Device; Failure to Advance; Device Damaged by Another Device
A NURSE REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION LENSES CAME OUT OF THE INJECTOR WITH THE FRONT HAPTIC STRETCHED ALSO THE LENSES WERE EVEN DEFECTIVE AT THE TRANSITION FROM OPTIC TO HAPTIC. THE SURGERIES COULD BE COMPLETED NORMALLY. FROM TIME TO TIME, THE LENS HAD TO BE EXPLANTED AND A NEW ONE IMPLANTED BECAUSE OF THE DEFECT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE FOUR MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS IS 3 OF 4.
Patient problems: Insufficient Information
MAUDE report 16611611 ↗MalfunctionMar 22, 2023Failure to Advance; Device Damaged by Another Device; Failure to Advance; Device Damaged by Another Device
A NURSE REPORTED DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENSES CAME OUT OF THE INJECTOR WITH THE FRONT HAPTIC STRETCHED ALSO THE LENSES WERE EVEN DEFECTIVE AT THE TRANSITION FROM OPTIC TO HAPTIC. THE SURGERIES COULD BE COMPLETED NORMALLY. FROM TIME TO TIME, THE LENS HAD TO BE EXPLANTED AND A NEW ONE IMPLANTED BECAUSE OF THE DEFECT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE FOUR MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS IS 2 OF 4.
Patient problems: Insufficient Information
MAUDE report 16593074 ↗MalfunctionAug 2, 2022Crack; Difficult to Advance; Crack; Difficult to Advance
A PHYSICIAN REPORTED THAT DURING IMPLANTATION OF INTRAOCULAR LENS (IOL), IT CAN BE PUSHED FORWARD WITH CONSIDERABLE EFFORT. POST IMPLANTATION A HAIRLINE CRACK CAN BE NOTED. THE LENS WAS NOT EXPLANTED AND IT WAS POSITIONED TO 12 O'CLOCK. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS IS 2 OF 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15145136 ↗MalfunctionJan 13, 2022Device Damaged by Another Device; Scratched Material; Device Damaged by Another Device; Scratched Material
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IOL TRAILING HAPTIC WAS BROKEN AT THE JOINT AFTER INSERTION IN TO THE EYE AND CAUSING THE CAUSING SCRATCHES AND MARKS ON THE OPTIC AND THERE WAS NO CHANCE OF THE LENS BEING ABLE TO SIT COMFORTABLY IN THE EYE WITHOUT CAUSING FURTHER COMPLICATIONS. THIS PROBLEM CAUSING DELAYED SURGERY TIME AND PROLONGED ANESTHETIC AS THE PATIENT WAS UNDER GENERAL ANESTHETIC. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THE HAPTIC WAS BROKEN WHERE IT MEETS THE OPTIC AND THE OPTIC ITSELF WAS AFFECTED. THERE WAS NO HARM CAUSED TO THE PATIENT AS THE SURGEON WAS ABLE TO CUT THE LENSES INSIDE THE EYE AND REPLACE WITH A THIRD IOL. THE ONLY REAL ISSUE IT CAUSED THE PATIENT WAS A PROLONGED HOSPITAL STAY DUE TO NEEDING A LONGER GENERAL ANESTHETIC. ALL ISSUES HAVE BEEN RESOLVED AND THE PATIENT HAS GOOD VISION FOLLOWING SURGERY. THE PATIENT WAS NOT HOSPITALIZED AND WENT HOME THE SAME DAY. THE TEMPERATURE AND HUMIDITY LEVELS IN THEATRE WERE ALSO OPTIMUM AND CAUSED NO PROBLEMS THAT MAY HAVE INFLUENCED THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13252721 ↗
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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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