AcrySof® UltraSert® ACU0T0 (REF ACU0T0.170)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
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00380652395199), received between Dec 28, 2021 and Aug 7, 2026 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Defective Device” (2 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
- Defective Device2
- Failure to Deliver2
- Break1
- Device Difficult to Setup or Prepare1
- Difficult to Advance1
- Failure to Eject1
- Failure to Fold1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Insufficient Information4
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2026Failure to Fold
Patient problems: Insufficient Information
MAUDE report 50176682 ↗MalfunctionJul 30, 2025Failure to Deliver; Failure to Deliver
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LES WAS STIFF AND RESISTANCE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22667351 ↗MalfunctionJul 30, 2025Failure to Deliver; Failure to Deliver
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LES WAS STIFF AND RESISTANCE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22666545 ↗MalfunctionJun 16, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED DURING A CATARACT AND INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN LOADING/PRIMING LENS WHOLE LENS WAS TWISTED WITH NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON SAME DAY WITH AN UNSPECIFIED NEW LENS WITHOUT ANY HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22213412 ↗MalfunctionJun 16, 2025Break; Break
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE THE INTRAOCULAR LENS HAPTIC WAS BROKEN IN DELIVERY SYSTEM. THE LENS WAS IMPLANTED AND REMOVED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED WITH BACK UP LENS. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22210594 ↗MalfunctionJan 8, 2025Difficult to Advance; Difficult to Advance
A HEALTH CARE PROFESSIONAL REPORTED THAT DELIVERY SYSTEM IS NOT WORKING PROPERLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21108576 ↗MalfunctionAug 6, 2024Failure to Eject; Failure to Eject
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED THAT LENS WAS IMPLANTED, PLUNGER KEPT STICKING DURING SURGERY. IOL HAD CONTACT WITH THE PATIENT AND PROCEDURE HAVE BEEN COMPLETED BY IMPLANTING THE LENS CORRECTLY. NO HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19919055 ↗MalfunctionApr 20, 2022Defective Device; Defective Device
A HEALTH PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY UPON INSERTION IN TO THE PATIENT EYE, PLASTIC RESIDUE WAS NOTICED. THEY HAD TO EXPLANT THE LENS AND INSERT A NEW ONE. ADDITIONAL INFORMATION RECEIVED AND STATED THAT IT FELT AND LOOKED AS IF THE LENS GRATED AS IT WENT THROUGH THE INJECTOR AND THEN HAD ¿SHAVINGS¿ ON THE EDGE. WHICH TRIED TO HOSE/ WASH OFF BUT COULDN¿T SO DID A LENS EXCHANGE.
Patient problems: Insufficient Information
MAUDE report 14159791 ↗MalfunctionDec 28, 2021Defective Device; Defective Device
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE DEFECTIVE LENS WAS NOT IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 13093357 ↗
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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