AcrySof® UltraSert® ACU0T0 (REF ACU0T0.155)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
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652395168), received between Dec 19, 2023 and Aug 28, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (3 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 Prepare3
- Break1
- Failure to Eject1
- Material Twisted/Bent1
- Unintended Ejection1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 28, 2026Device Difficult to Setup or Prepare; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50497977 ↗MalfunctionFeb 6, 2026Break
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON DISCOVERED THAT THE DEVICE WAS SHARP EDGED. ADDITIONALLY, THEY HAVE NOTICED THAT THE PLUNGER TIP WAS BROKEN AND A COMPLICATION AROSE SHORTLY AFTERWARD DUE TO THE INJECTOR. THIS POSES A POTENTIAL RISK TO HIM DURING THE SHOOT AND THUS A POSSIBLE DELAY IN WOUND HEALING. HOWEVER, THE IOL (INTRAOCULAR LENS) WAS IMPLANTED BECAUSE THE LENS ITSELF WAS NOT DEFECTIVE.
Patient problems: Insufficient Information
MAUDE report 24278287 ↗MalfunctionSep 10, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF DEFECTIVE PRELOADED INTRAOCULAR LENS (IOL) DEVICE. REPLACEMENT IOL WAS SUPPLIED. IT WAS UNKNOWN IF THE PROCEDURE WAS COMPLETED ON SAME DAY OR NOT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23016006 ↗MalfunctionJan 23, 2025Device Difficult to Setup or Prepare; Failure to Eject; Device Difficult to Setup or Prepare; Failure to Eject
A HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE AT CALIBRATION AND SETUP, THE LENS WAS STUCK IN INJECTOR AND HAPTIC IS AT SUPERMAN POSITION WITH NO PATIENT HARM AND PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21216228 ↗MalfunctionDec 19, 2023Unintended Ejection; Unintended Ejection
AN OTHER HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE SCRUB NURSE PRIMED THE LENS AS INSTRUCTED. THE PLUNGER WAS PUSHED UNTIL LENS REACHED THE MARKER LINE. THE LENS FOLDED ROUTINELY. THE SURGEON INSPECTED AND INSERTED THE LENS. THE LENS CAME OUT AND THE LEADING HAPTIC WAS RELEASED. THE SURGEON NOTICED THAT THE LENS HAD FLIPPED INSIDE THE EYE. THE SURGEON ASSESSED THE SITUATION AND OPTED TO DISCONTINUE INSERTING THE CURRENT LENS. A NEW LENS WITH THE SAME POWER WAS OPENED AND INSERTED TO THE PATIENT EYE WITHOUT COMPLICATION. THE LENS WAS DISPOSED BY THE SURGEON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18354612 ↗
Other intraocular lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page