AcrySof® UltraSert® AU00T0 (UDI 00380652394727)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 uses a preloaded delivery system for cataract surgery. The 24 reports mostly describe the lens or delivery parts not folding, deploying, or releasing properly, with some haptics bending or breaking during implantation. They include 7 injuries and no deaths. No recalls name this device, and reports fell from 8 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
- 27
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00380652394727), received between Mar 30, 2021 and Sep 1, 2026 — classified as 7 injuries, 20 malfunctions.
The most frequently reported specific device problem is “Device Damaged by Another Device” (6 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 Device6
- Device Difficult to Setup or Prepare6
- Break3
- Defective Component3
- Adverse Event Without Identified Device or Use Problem2
- Defective Device2
- Failure to Advance2
- Failure to Deliver2
Patient problems
- Insufficient Information13
- No Clinical Signs, Symptoms or Conditions9
- Capsular Bag Tear3
- Eye Injury2
- Eye Pain1
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 1, 2026Device Difficult to Setup or Prepare
Patient problems: Insufficient Information
MAUDE report 50543018 ↗MalfunctionSep 1, 2026Device Difficult to Setup or Prepare
Patient problems: Insufficient Information
MAUDE report 50542998 ↗MalfunctionAug 7, 2026Device Damaged by Another Device
Patient problems: Eye Injury
MAUDE report 50172585 ↗MalfunctionJul 7, 2026Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC BENT DURING IMPLANTATION AND COULD NOT BE RELEASED DESPITE MANIPULATION. THE LENS WAS NOT IMPLANTED AND DID NOT COME INTO CONTACT WITH THE PATIENT. THE AFFECTED LENS WAS NOT USED AND WAS REPLACED WITH AN ALTERNATIVE UNSPECIFIED LENS TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25733869 ↗MalfunctionFeb 11, 2026Failure to Fold
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS NOT FOLDED CORRECTLY. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH UNSPECIFIED REPLACEMENT IOL. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24311301 ↗MalfunctionJan 22, 2026Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED AN ISSUE, DESCRIBING THE INJECTOR WAS FAULTY. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24144013 ↗MalfunctionAug 19, 2025Failure to Advance; Failure to Advance
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE PLUNGER DID NOT FUNCTION PROPERLY. THERE WAS NO PATIENT HARM. THE PROCEDURE WAS COMPLETED WITH UNSPECIFIED LENS. THERE WAS 1 MINUTE DELAY IN PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22839598 ↗MalfunctionAug 6, 2025Device Damaged by Another Device; Device Damaged by Another Device
A PHYSICIAN REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS FOUND TO BE DEFECTIVE UNDER THE MICROSCOPE AND THEREFORE IT WAS NOT IMPLANTED.ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22730854 ↗MalfunctionAug 1, 2025Break; Failure to Deliver; Break; Failure to Deliver
THIS REPORT WAS RECEIVED FROM MEDSAFE HEALTH AUTHORITY VIA A NON-HEALTHCARE PROFESSIONAL STATED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, SURGEON HAD DEPLOYED THE PLUNGER AND INSERTED THE IOL INTO THE PATIENT¿S RIGHT EYE. THE SURGEON OBSERVED THAT THE TRAILING HAPTIC OF THE IOL WAS FIRMLY STUCK TO THE TIP OF THE PLUNGER AND WAS DIFFICULT TO REMOVE. IT SUBSEQUENTLY BROKE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. NO FURTHER INFORMATION EXPECTED.
Patient problems: Insufficient Information
MAUDE report 22686337 ↗MalfunctionMay 23, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED THAT THE LENS WAS DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22077552 ↗MalfunctionApr 18, 2025Break; Device Difficult to Setup or Prepare; Break; Device Difficult to Setup or Prepare
ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THE PATIENT WAS IN GOOD HEALTH CONDITION AND NOTHING FURTHER WAS PLANNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21864136 ↗InjuryMar 21, 2025Device Damaged by Another Device; Device Damaged by Another Device
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS IMPLANTATION PROCEDURE, THE INSERTER DAMAGED THE LENS. THE LENS WAS INSERTED AND REMOVED DURING THE INITIAL PROCEDURE, AN ANTERIOR VITRECTOMY WAS PERFORMED, AND THE LENS WAS REPLACED WITH THE COMPANY LENS.
Patient problems: Insufficient Information
MAUDE report 21663990 ↗MalfunctionFeb 19, 2025Scratched Material; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE PHYSICIAN NOTICED SCRATCH MARK ON THE LENS AFTER IMPLANTATION. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS DURING THE SAME PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 21417869 ↗MalfunctionDec 27, 2024Break; Break
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, TAILING HAPTIC WAS BROKEN. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH ANOTHER LENS. THERE IS NO HARM TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED STATING THAT IN THE SURGEON'S OPINION EVENT WAS MAY BE DUE TO COLD WEATHER BUT ALL LENSES WERE STORED UNDER TEMPERATURE CONTROL ROOM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21025432 ↗InjurySep 24, 2024Defective Component; Adverse Event Without Identified Device or Use Problem; Defective Component; Adverse Event Without Identified Device or Use Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, HE HAD TO WIDEN THE INCISION FOR EVERY SUSPECT DEVICE USED. THE SURGEON STATED THAT THE USUAL INCISION SIZE WAS 2.4 MM, BUT THIS WASN'T ENOUGH FOR THE SUSPECT DEVICE, SO HE HAD TO WIDEN THE INCISION TO 2.5 TO 2.6 MM TO INSERT THE CARTRIDGE TIP INTO THE PATIENT'S EYE. THERE WAS PATIENT CONTACT, BUT NO IMPACT ON THE PATIENT AS THE CATARACT OPERATION WAS COMPLETED WITHOUT ANY PROBLEMS AFTER THE INCISIONS WERE WIDENED. THERE ARE SEVEN MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 2 OF 7.
Patient problems: Eye Injury
MAUDE report 20291284 ↗InjuryApr 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED INFERIORLY SUBLXED LENS WITHOUT TRAUMA. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL APPROXIMATELY 5 AND HALF YEARS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19114057 ↗InjuryNov 15, 2023Unintended Ejection; Unintended Ejection
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, REPORTED WITH A DESCRIPTION OF LOADER SHOT AT FORCE. NEW INFORMATION HAS BEEN RECEIVED INCLUDES POSTERIOR CAPSULAR TEAR, SEVERE PAIN, LENS WAS EXPLANTED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED FROM THE SURGEON STATING THAT PROGNOSIS REMAINS GUARDED. PATIENT HAS NOT HAD THE NEXT SURGERY YET BUT SHOULD WITHIN THE NEXT FEW WEEKS. THE PROBLEM WAS THAT SHE DOES NOT WANT TO HAVE ANY MORE SURGERY UNLESS IT WAS UNDER GENERAL ANESTHESIA AND MOST LIKELY NEED TO HAVE A VITRECTOMY WITH WOUND REVISION FOLLOWED BY SECONDARY LENS IMPLANTATION. PATIENT WAS STABLE BUT HER INTRAOCULAR PRESSURE (IOP) HAS BEEN DIFFICULT TO CONTROL AND SURGEON CONCERNED ABOUT FURTHER VISION LOSS DUE TO THIS.
Patient problems: Capsular Bag Tear; Eye Pain
MAUDE report 18137344 ↗MalfunctionAug 29, 2023Defective Component; Failure to Advance; Device Damaged by Another Device; Defective Component; Failure to Advance; Device Damaged by Another Device
A PHARMACIST REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION, IMPLANT DOES NOT ENGAGE, PLUNGER BLOCKED AND IT WAS IMPOSSIBLE TO INSERT IMPLANT BECAUSE DAMAGED DUE TO BLOCKAGE. THERE WAS NO PATIENT HARM AND THE SURGERY WAS COMPLETED WITH ANOTHER LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17641984 ↗InjuryOct 7, 2022Crack; Material Split, Cut or Torn; Crack; Material Split, Cut or Torn
ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING AT THE FOLLOW-UP VISIT, THE OPERATED EYE WAS ADDITIONALLY RINSED AND A BANDAGE CONTACT LENS WAS APPLIED (CONTACT LENS). FURTHERMORE, THE FEMALE PATIENT RECEIVED EYE DROPS. THE FURTHER COURSE PROVED TO BE INCONSPICUOUS AND NO HOSPITALIZATION WAS NECESSARY.
Patient problems: Insufficient Information
MAUDE report 15564140 ↗MalfunctionMay 16, 2022Device Damaged by Another Device; Device Damaged by Another Device
A NON HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE LENS WAS NOTED DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 14404914 ↗MalfunctionMay 12, 2022Defective Device; Device Damaged by Another Device; Defective Device; Device Damaged by Another Device
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE IS A DENT/SCRATCH ON THE LENS . ADDITIONAL INFORMATION HAS BEEN REQUESTED AND PROVIDED THAT DAMAGE LENS REMOVED AND SURGERY WAS COMMENCED USING A NEW LENS WITH SAME DIOPTER. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14377098 ↗InjuryApr 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE CAPSULE TEAR WAS NOTED AFTER LENS WAS IMPLANTED. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS. THE CAPSULAR BAG WAS NOT INTACT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Capsular Bag Tear
MAUDE report 14201639 ↗MalfunctionMar 23, 2022Inaccurate Delivery; Inaccurate Delivery
A NON-HEALTH PROFESSIONAL REPORTED THAT, INTRAOCULAR LENS, DIDN'T COME OUT OF THE INJECTOR CORRECTLY. ONE OF THE HAPTICS WAS IN WRONG POSITION.
Patient problems: Insufficient Information
MAUDE report 13857771 ↗InjuryFeb 22, 2022Unintended Ejection; Unintended Ejection
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS RAPIDLY LEFT THE INJECTOR (RATHER THAN THE SMOOTH INSERTION) RESULTING IN A CAPSULAR TEAR. SURGEON WAS PLACED THE LENS IN THE CAPSULAR BAG AND SURGERY WAS SUCCESSFULLY COMPLETED WITH TAKING AN EXTRA 10 MINUTES ON NORMAL SURGERY TIME. NO ISSUES WITH THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Capsular Bag Tear
MAUDE report 13576816 ↗MalfunctionNov 24, 2021Defective Component; Defective Component
A NURSE REPORTED DURING THE PREPARATION OF THE IOL WHILE REMOVING "THE BLUE LENS LOCK" THE CARTRIDGE OPENED AND EXPOSED IOL. IT SEEMED LIKE THE SMALL CLIP HOLDING THE LENS CHAMBER CLOSED WAS LOOSE. THE SURGERY WAS DELAYED FOR A FEW MINUTES BUT WAS COMPLETED WITH A BACK UP LENS WITHOUT ANY ENLARGED INCISIONS NOR ANY SUTURES WERE NEEDED. THERE WAS NO PATIENT HARM AND THE PATIENT WAS OK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12870066 ↗
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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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