AcrySof® UltraSert® ACU0T0 (REF ACU0T0.205)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
AcrySof UltraSert preloaded intraocular lens reports describe haptics bending or missing, lenses snapping, and injector failure during implant surgery, often with no patient contact. The database lists 40 reports naming this device identifier, including 5 injuries, no deaths, and 35 malfunctions. 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
- 39
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00380652395267), received between Apr 15, 2021 and Aug 28, 2026 — classified as 5 injuries, 34 malfunctions.
The most frequently reported specific device problem is “Device Damaged by Another Device” (7 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 Device7
- Failure to Advance7
- Defective Device4
- Material Twisted/Bent4
- Device Difficult to Setup or Prepare3
- Failure to Eject3
- Scratched Material3
- Failure to Fold2
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- Insufficient Information11
- Eye Injury2
- Visual Disturbances2
- Capsular Bag Tear1
Recent adverse event reports
The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 28, 2026Device Difficult to Setup or Prepare
A healthcare professional reported during intraocular lens (IOL) implant procedure, the trailing haptic folded wrong. There was no patient contact, and this was frequently observed.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 50500186 ↗MalfunctionMay 11, 2026Device Damaged by Another Device
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING THE INTRAOCULAR LENS IMPLANTATION SURGERY, THE HAPTIC WAS MISSING. THERE WAS NO PATIENT CONTACT. THE SURGERY WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT ANOTHER LENS WAS USED TO COMPLETE THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25137884 ↗MalfunctionApr 3, 2026Material Twisted/Bent
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE HAPTIC WAS BENT IN TWO LENSES AND THE THIRD LENS WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO PATIENT CONTACT AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24781248 ↗MalfunctionApr 3, 2026Material Twisted/Bent
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE HAPTIC WAS BENT IN TWO LENSES AND THE THIRD LENS WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO PATIENT CONTACT AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24774576 ↗MalfunctionDec 19, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23848091 ↗MalfunctionNov 25, 2025Failure to Deliver; Failure to Deliver
A NONHEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL)IMPLANTATION SURGERY, THE INJECTOR FAILED TO DEPLOY. THE PROCEDURE WAS COMPLETED ON THE SAME DAY.
Patient problems: Insufficient Information
MAUDE report 23644927 ↗MalfunctionOct 31, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTH CARE PROFESSIONAL REPORTED WITH THE DESCRIPTION DEFECTIVE LENS. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE HAPTIC WAS TORN AND THERE WAS NO PATIENT CONTACT. THE SURGERY COMPLETED WITH UNSPECIFIED REPLACEMENT LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23438170 ↗MalfunctionOct 27, 2025Device Difficult to Setup or Prepare; Failure to Prime; Scratched Material; Device Difficult to Setup or Prepare; Failure to Prime; Scratched Material
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS DID NOT LOAD CORRECTLY, TRAILING HAPTIC AND POSSIBLE SCRATCH ON LENS. THERE WAS NO PATIENT CONTACT AND NO PATIENT HARM. THE PROCEDURE WAS COMPLETED WITH ANOTHER LENS WITH THE SAME DIOPTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23391254 ↗MalfunctionSep 2, 2025Failure to Fold; Failure to Fold
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS DID NOT FOLD AND THE LENS CAME OUT FLAT. SO IT WAS UNABLE TO BE INSERTED INTO THE EYE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE SURGERY WAS COMPLETED ON THE SAME DAY USING DIFFERENT LENS AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22935869 ↗MalfunctionSep 2, 2025Failure to Fold; Failure to Fold
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS DID NOT FOLD AND THE LENS CAME OUT FLAT. SO IT WAS UNABLE TO BE INSERT INTO THE EYE. THE SURGERY WAS COMPLETED ON THE SAME DAY USING ANOTHER LENS AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22932113 ↗MalfunctionJul 22, 2025Failure to Advance; Failure to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INTRODUCER WENT ON TOP OF THE LENS INSTEAD OF ENGAGING THE LENS. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22566859 ↗MalfunctionJul 18, 2025Material Twisted/Bent; Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS TRAILING HAPTIC TWISTED UNDER THE PLUNGER, WHILE PRIMING. THERE WAS NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER UNSPECIFIED LENS ON SAME DAY WITHOUT ANY HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22540466 ↗MalfunctionJun 10, 2025Device Damaged by Another Device; Device Damaged by Another Device
THE SURGEON REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS CRUMPLED WITHIN THE DELIVERY CHAMBER. THE SURGERY COMPLETED WITH BACKUP LENS. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THERE WAS NO PATIENT CONTACT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE 2 OF 2 FILES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22177304 ↗MalfunctionJan 20, 2025Defective Device; Defective Device
A HEALTH CARE PROFESSIONAL REPORTED WITH THE DESCRIPTION, DEFECTIVE INTRAOCULAR LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21191378 ↗MalfunctionAug 28, 2024Device Damaged by Another Device; Material Twisted/Bent; Device Damaged by Another Device; Material Twisted/Bent
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN PRIMING LENS IT WAS NOTED THAT THE LENS WAS TWISTED, SCRUB NURSE ASKED SURGEON TO CHECK, WHEN TRIED TO INJECT IN EYE LENS CAME OUT TWISTED. LENS NOT USED. THERE WAS NO CONTACT WITH IOL BUT CONTACT WITH THE INJECTOR TIP. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20083400 ↗MalfunctionAug 27, 2024Defective Device; Defective Device
A HEALTH CARE PROFESSIONAL REPORTED FOUR DEFECTIVE PRODUCTS.
Patient problems: Insufficient Information
MAUDE report 20073985 ↗MalfunctionMay 14, 2024Device Damaged by Another Device; Device Damaged by Another Device
A NURSE REPORTED THAT THE INTRAOCULAR LENS (IOL) BROKE UPON INSERTION. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 19310588 ↗MalfunctionApr 15, 2024Failure to Advance; Failure to Advance
A SERVICE MANAGER REPORTED ABOUT A COMPLAINT OF LENS STUCK IN THE INJECTOR. THERE WAS NO PATIENT HARM. THE SURGERY WAS COMPLETED WITH A NEW LENS. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19105415 ↗MalfunctionApr 15, 2024Failure to Advance; Failure to Advance
A SERVICE MANAGER REPORTED ABOUT A COMPLAINT OF LENS STUCK IN THE INJECTOR. THERE WAS NO PATIENT HARM. THE SURGERY WAS COMPLETED WITH A NEW LENS. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 1 OF 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19105411 ↗MalfunctionApr 15, 2024Failure to Advance; Failure to Advance
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS GOT STUCK IN THE INJECTOR. ADDITIONAL INFORMATION WAS REQUESTED, AND RECEIVED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19103956 ↗MalfunctionMar 6, 2024Failure to Eject; Failure to Eject
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS STUCK IN THE INJECTOR. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18844904 ↗MalfunctionFeb 23, 2024Failure to Advance; Failure to Advance
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS STUCK IN INJECTOR AND DID NOT FULLY EJECT INTO THE EYE. UNSPECIFIED NEW LENS WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18765516 ↗MalfunctionNov 21, 2023Failure to Eject; Failure to Eject
ADDITIONAL INFORMATION RECEIVED AND STATED THE LENS DID NOT HAVE DIRECT CONTACT WITH THE PATIENT. DURING THE PREPARATION OF THE LENS FOR IMPLANTATION, IT WAS BLOCKED IN THE INJECTOR.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18180479 ↗MalfunctionAug 1, 2023Device Damaged by Another Device; Physical Resistance/Sticking; Device Damaged by Another Device; Physical Resistance/Sticking
A FACILITY REPRESENTATIVE REPORTED THAT IN AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DURING PRIMARY LOADING, THE PLUNGER WAS BEING PUSHED UP AND IT LOOKED LIKE THE LEADING HAPTIC WAS STUCK AND WAS BEING STRETCHED WHILE THE PLUNGER WAS MOVING THE LENS FORWARD. DOCTOR INJECTED IT INTO PATIENT'S EYE WITH MORE RESISTANCE THAN NORMAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17434223 ↗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 4 OF 4.
Patient problems: Insufficient Information
MAUDE report 16611609 ↗
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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 13, 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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