AcrySof® UltraSert® ACU0T0 (REF ACU0T0.250)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 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00380652395359), received between Jun 8, 2022 and Aug 28, 2026 — classified as 1 injury, 14 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (5 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Difficult to Setup or Prepare5
- Failure to Advance4
- Defective Device2
- Break1
- Ejection Problem1
- Failure to Eject1
- Failure to Unfold or Unwrap1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- Insufficient Information7
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 28, 2026Device Difficult to Setup or Prepare
Patient problems: Insufficient Information
MAUDE report 50499307 ↗MalfunctionMar 30, 2026Device Difficult to Setup or Prepare
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION, LENSES DID NOT LOAD CORRECTLY AND THE TRAILING HAPTIC WAS STUCK UNDER THE PLUNGER. PROCEDURE WAS COMPLETED ON THE SAME DAY USING SAME DIOPTER LENS. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24714213 ↗MalfunctionNov 6, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE INCIDENT OCCURRED DURING LOADING. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23485821 ↗MalfunctionOct 28, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC STUCK IN THE INTRODUCER WITH NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON SAME DAY BY THE ANOTHER UNSPECIFIED LENS BUT WITHOUT ANY HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23402733 ↗MalfunctionAug 14, 2025Failure to Advance; Failure to Advance
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE FAULTS WERE LENS TRAPPED UNDER THE PLUNGER AND THEREFORE NOT COMING OUT OF THE INJECTOR. THERE WAS PATIENT CONTACT AND NO PATIENT HARM. THE PROCEDURE COMPLETED ON THE SAME DAY WITH ANOTHER LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22804520 ↗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 22052506 ↗MalfunctionMar 27, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED THAT UNFORTUNATELY THE IOL DID NOT WORK. THE PROCEDURE WAS COMPLETED BY USING COMPANY ANOTHER LENS OF SAME MODEL AND DIOPTER.
Patient problems: Insufficient Information
MAUDE report 21716031 ↗MalfunctionMar 26, 2025Failure to Advance; Failure to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PLUNGER DID NOT ENGAGE WITH PATIENT CONTACT. THE PROCEDURE WAS NOT COMPLETED ON SAME DAY WITHOUT ANY HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21700813 ↗MalfunctionOct 23, 2024Defective Device; Defective Device
A NON-HEALTHCARE PROFESSIONAL REPORTED A DEFECTIVE LENS. THERE WERE PROBLEMS WITH THE INJECTOR. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 20514612 ↗InjuryJun 12, 2024Break; Break
A OTHER HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SURGEON NOTICED THE HAPTIC WAS DISCONNECTED FROM LENS BODY IN THE EYE, SURGEON REMOVED LOOSE HAPTIC, AND THE LENS WAS NOT STABLE. SURGEON HAD TO REMOVE LENS AND PLACE STITCHES INTO EYE, BEFORE IMPLANTING ANOTHER LENS. EXTENDED SURGERY TO APPROXIMATELY AN HOUR LONG. LEVEL OF HARM WAS MODERATE PHYSICAL HARM. PATIENT WAS SEEN 2 DAYS AND 2 WEEKS POST-OPERATIVELY WITH VISION GETTING BETTER AND IMPROVING EACH DAY.
Patient problems: Insufficient Information
MAUDE report 19524132 ↗MalfunctionApr 15, 2024Failure to Eject; Failure to Eject
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS FAILED TO LOAD. ADDITIONAL INFORMATION HAS BEE REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19104742 ↗MalfunctionMar 15, 2024Defective Device; Defective Device
ADDITIONAL INFORMATION HAS BEEN REQUESTED AD RECEIVED. THE LENS WAS NOT USED.
Patient problems: Insufficient Information
MAUDE report 18913492 ↗MalfunctionFeb 15, 2023Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT PROCEDURE, LENS CAME OUT OF INJECTOR AND WOULD NOT UNFOLD. THERE WAS PATIENT CONTACT NOTED AND PROCEDURE WAS COMPLETED ON THE SAME DAY.
Patient problems: Insufficient Information
MAUDE report 16378490 ↗MalfunctionAug 24, 2022Failure to Advance; Failure to Advance
A HEALTH PROFESSIONAL REPORTED WITH A DESCRIPTION OF FAULTY INTRAOCULAR LENS (IOL) ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, THERE WAS A PROBLEM WITH THE RELEASE OF THE LENSES.
Patient problems: Insufficient Information
MAUDE report 15281308 ↗MalfunctionJun 8, 2022Ejection Problem; Ejection Problem
A HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE LENS WENT INTO THE EYE BACKWARDS. ADDITIONAL INFORMATION HAS BEEN REQUESTED WHICH STATES THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14632600 ↗
Other intraocular lens devices
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- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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