AcrySof® UltraSert® ACU0T0 (REF ACU0T0.185)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
- 18
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00380652395229), received between Apr 13, 2021 and Aug 7, 2026 — classified as 18 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
- Defective Device3
- Failure to Eject3
- Break2
- Device Damaged by Another Device2
- Device Contamination with Chemical or Other Material1
- Failure to Advance1
- Failure to Fold1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- Insufficient Information7
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2026Device Difficult to Setup or Prepare
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50173837 ↗MalfunctionJan 8, 2026Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED WITH THE DESCRIPTION OF HAPTIC CONTORTED. THE SURGERY WAS COMPLETED USING REPLACEMENT LENS. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24003891 ↗MalfunctionDec 5, 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 DID NOT UNFOLD, REMAIN STRAIGHT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THERE WAS NO PATIENT CONTACT AND HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23729652 ↗MalfunctionAug 28, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF DEFECTIVE HAPTIC. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT DURING AN INTRAOCULAR LENS(IOL) IMPLANT PROCEDURE THE HAPTIC WAS NOT INTACT AND HAPTIC DID NOT FOLD PROPERLY IN THE SHOOTER. THE SURGERY WAS COMPLETED WITH THE REPLACEMENT LENS. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22913269 ↗MalfunctionMay 23, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTH CARE PROFESSIONAL REPORTED ABOUT A DEFECTIVE DEVICE. NO OTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 22079053 ↗MalfunctionApr 23, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED THAT LENS WAS DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21893007 ↗MalfunctionSep 25, 2024Defective Device; Defective Device
A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF FAULTY. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20299750 ↗MalfunctionAug 27, 2024Defective Device; Defective Device
A HEALTH CARE PROFESSIONAL REPORTED FOUR DEFECTIVE PRODUCTS. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 20073988 ↗MalfunctionApr 16, 2024Failure to Eject; Failure to Eject
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS STUCK IN THE INJECTOR. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, THE PROCEDURE WAS COMPLETED WITH THE ANOTHER LENS. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19114098 ↗MalfunctionApr 8, 2024Failure to Eject; Failure to Eject
A PHYSICIAN REPORTED ABOUT A LENS WAS STUCK IN THE CARTRIDGE. NO INFORMATION WAS PROVIDED RELATED TO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19057963 ↗MalfunctionMar 5, 2024Failure to Advance; Failure to Advance
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS STUCK IN THE INJECTOR AND DID NOT FULLY EJECT INTO THE EYE. HENCE A NEW LENS WAS USED TO COMPLETE THE SURGERY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18835537 ↗MalfunctionApr 26, 2023Device Damaged by Another Device; Device Damaged by Another Device
A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS THAT WAS DAMAGED IN THE PRE-LOADER. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THERE WAS NO PATIENT HARM
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16814906 ↗MalfunctionAug 8, 2022Defective Device; Device Damaged by Another Device; Defective Device; Device Damaged by Another Device
A STOCK CONTROL AND PURCHASING LEAD REPORTED THAT, HAVE A SECOND INSTANT OF FAULTY PRODUCTS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15184463 ↗MalfunctionJun 16, 2022Failure to Eject; Failure to Eject
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PLUNGER WENT OVER THE IOL. THE SURGERY WAS COMPLETED WITH BACK UP LENS DURING THE INITIAL PROCEDURE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14713735 ↗MalfunctionApr 11, 2022Failure to Fold; Failure to Fold
A HEALTH CARE PROFESSIONAL REPORTED THAT, DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON WAS FOUND THAT IOL PLUNGE MADE THE IOL FOLD INCORRECTLY. THE PROCEDURE WAS COMPLETED BY THE HELP OF ANOTHER INSTRUMENT TO MAKE THE IOL UNFOLD AND PLACED CORRECTLY IN THE CAPSULE. THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14075360 ↗MalfunctionMar 11, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
A PHYSICIAN REPORTED DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE, A THREAD MAY HAVE BEEN ON OR ATTACHED TO THE IOL. IT WAS IMPLANTED WITH THE LENS AND THEN REMOVED IN THE SAME PROCEDURE. IOL REMAINS IMPLANTED. THERE WAS A MINOR DELAY IN THE PROCEDURE WHICH WAS FOUND NOT SIGNIFICANT BY THE SURGEON. NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13733629 ↗MalfunctionAug 24, 2021Break; Break
A NURSE REPORTED DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION THE LENS WAS BROKEN. ADDITIONAL INFORMATION WAS REQUESTED BUT NO NEW INFORMATION WAS OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12359376 ↗MalfunctionApr 13, 2021Break; Break
A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS IMPLANTATION (IOL) PROCEDURE OF THE RIGHT EYE, UPON MICROSCOPIC EXAMINATION, THE IOL WAS CHIPPED. THE IOL WAS REMOVED AND EXCHANGED WITH AN ALTERNATE IOL. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11656225 ↗
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- 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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