AcrySof® UltraSert® ACU0T0 (REF ACU0T0.175)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
- 16
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00380652395205), received between May 25, 2021 and Nov 11, 2025 — classified as 2 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Failure to Eject” (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
- Failure to Eject5
- Device Damaged by Another Device4
- Failure to Advance3
- Adverse Event Without Identified Device or Use Problem2
- Device Difficult to Setup or Prepare2
- Appropriate Device Problem Term/Code Not Available1
- Defective Component1
- Failure to Deliver1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- Insufficient Information5
- Capsular Bag Tear1
- Eye Pain1
- Inflammation1
- Iritis1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 11, 2025Device Difficult to Setup or Prepare; Device Damaged by Another Device; Device Difficult to Setup or Prepare; Device Damaged by Another Device
A HEALTH CARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHILE INSERTION, A DISTAL LOOP BECAME STUCK IN INJECTOR AND BROKE WITH NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE CATARACT SURGERY WAS POSSIBLE WITH THE AID OF ANOTHER REPLACEMENT DEPOSIT LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23522530 ↗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). 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 23507020 ↗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 WAS 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 22804352 ↗MalfunctionAug 13, 2025Failure to Advance; Failure to Advance
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE PLUNGER OVERRODE THE LENS AND FAILED TO DELIVER INTO THE LENS INTO THE EYE. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT, THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ANOTHER LENS WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22795968 ↗MalfunctionNov 21, 2024Defective Component; Defective Component
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY STATING NOT LATCHED PROPERLY LOSE CARTRIDGE. NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT DEVICE NOZZLE WAS LOOSE.
Patient problems: Insufficient Information
MAUDE report 20742897 ↗MalfunctionOct 30, 2024Failure to Eject; Failure to Eject
A PHARMACIST REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS WAS STUCK IN INJECTOR. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20569852 ↗MalfunctionJun 6, 2024Failure to Eject; Failure to Eject
A HEALTH CARE PROFESSIONAL REPORTED THAT THE PLUNGER MISSED THE LENS TO THE RIGHT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19475169 ↗MalfunctionJun 4, 2024Failure to Eject; Failure to Eject
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF PLUNGER NOT ENGAGING WITH THE LENSES. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19458385 ↗MalfunctionMar 15, 2024Failure to Advance; Failure to Advance
A SERVICE MANAGER REPORTED A FAULTY LENS. ADDITIONAL INFORMATION WAS RECEIVED. THE LENS STUCK INTO THE INJECTOR WHILE INJECTING THE LENS INTO PATIENT'S EYE. THE SURGERY WAS COMPLETED ON SAME DAY. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18912367 ↗MalfunctionNov 16, 2023Failure to Eject; Failure to Eject
A HEALTHCARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS (IOL) IMPLANT THE PLUNGER OF THE WAS JAMMED AND LENS WOULD NOT ADVANCE. THE SURGERY WAS COMPLETED WITH REPLACEMENT LENS DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18148126 ↗MalfunctionMar 7, 2023Device Damaged by Another Device; Device Damaged by Another Device
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY THE LENS WAS DAMAGED AND WASTED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 16493957 ↗InjuryNov 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE CAPSULAR BAG WAS RUPTURED. THE IOL WAS REPLACED WITH ANOTHER LENS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATED THAT THE PHYSICIAN DID NOT SUSPECT THE LENS CAUSED THE RUPTURE. IT WAS NOT CONFIRMED THE BAG DID RUPTURE, IT WAS ONLY SUSPECTED. IT WAS DECIDED TO PUT IN A SULCUS LENS AS A PRECAUTIONARY MEASURE. NO VITREOUS WAS DETECTED.
Patient problems: Capsular Bag Tear
MAUDE report 12738958 ↗MalfunctionJul 27, 2021Failure to Deliver; Failure to Eject; Failure to Deliver; Failure to Eject
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PLUNGER WENT OVER THE LENS. NO PATIENT HARM. THE PROCEDURE WAS COMPLETED BY USING A BACK UP LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12231357 ↗MalfunctionJun 28, 2021Inaccurate Delivery; Device Damaged by Another Device; Inaccurate Delivery; Device Damaged by Another Device
A FACILITY REPRESENTATIVE REPORTED THAT, LENS JAMMED IN PRELOADED DELIVERY SYSTEM AND WAS IMPLANTED INCORRECTLY. LENS WAS CUT OUT AND REPLACED WITH A NEW ONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12074591 ↗InjuryJun 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD CHRONIC INFLAMMATION WITH ASSOCIATED OCULAR PAIN. THE IOL WAS EXPLANTED 6 MONTHS FOLLOWING THE INITIAL PROCEDURE. THE PATIENT HARM OCULAR PAIN/IRITIS WAS REPORTED. THE PHYSICIAN'S PROGNOSIS WAS GUARDED. THE PATIENT LEFT APHAKIC AND WILL REQUIRE ADDITIONAL SURGERY FOR SECONDARY IMPLANT AT LATER DATE.
Patient problems: Eye Pain; Inflammation; Iritis
MAUDE report 11967738 ↗MalfunctionMay 25, 2021Device Damaged by Another Device; Appropriate Device Problem Term/Code Not Available; Device Damaged by Another Device; Appropriate Device Problem Term/Code Not Available
ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE LENS WAS INSERTED/REMOVED SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11878082 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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