AcrySof® UltraSert® ACU0T0 (REF ACU0T0.160)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
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652395175), received between Feb 11, 2023 and Sep 13, 2026 — classified as 7 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
- Component Missing1
- Defective Device1
- Failure to Advance1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Insufficient Information1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 13, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50747010 ↗MalfunctionNov 7, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DIFFICULT TO REMOVE, COULD NOT BE USED. ADDITIONAL INFORMATION RECEIVED STATING THAT THERE WAS TRAILING HAPTIC ISSUE. THE SURGERY WAS COMPLETED BY USING REPLACEMENT LENS. THERE WAS NO PATIENT CONTACT AND HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23503703 ↗MalfunctionNov 7, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS FOUND TO BE DIFFICULT TO REMOVE LENS. THE LENS HAD DELIVERY-RELATED ISSUES. HOWEVER, THE LENS COULD NOT BE USED, AND AN ADDITIONAL UNSPECIFIED LENS HAD TO BE OPENED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE LENS TRAILING HAPTIC WAS DELIVERED FIRST. THE IOL WAS IMPLANTED WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23496451 ↗MalfunctionAug 7, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, TRAILING HAPTIC STUCK BETWEEN THE INJECTOR AND THE PLUNGER. IT FELT DURING LOADING AND ASKED SURGEON TO CHECK BEFORE INJECTING IN THE EYE. THE SURGERY WAS COMPLETED WITH DIFFERENT LENS. THERE WAS NO PATIENT CONTACT AND HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22735052 ↗MalfunctionMar 24, 2025Material Twisted/Bent; Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS(IOL) IMPLANT PROCEDURE DURING INJECTION THE TRAILING HAPTIC UNFOLDED AND WAS STRAIGHT INSIDE THE CARTRIDGE. THERE WAS A PATIENT CONTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER LENS. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21677864 ↗MalfunctionDec 12, 2023Defective Device; Defective Device
A HEALTHCARE PROFESSIONAL REPORTED THAT THERE WAS AN UNSPECIFIED ISSUE WITH IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18309582 ↗MalfunctionFeb 11, 2023Component Missing; Failure to Advance; Component Missing; Failure to Advance
A HEALTH CARE PROFESSIONAL REPORTED THAT, DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT PROCEDURE, IT WAS FOUND THAT LENS EITHER MISSING OR LODGED IN THE BARREL OF INJECTOR. THERE WAS PATIENT CONTACT NOTED, HOWEVER NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16359623 ↗
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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