AcrySof® UltraSert® ACU0T0 (REF ACU0T0.265)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
- 6
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652395380), received between Dec 27, 2021 and Apr 1, 2026 — classified as 1 injury, 5 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Defective Component1
- Defective Device1
- Device Damaged by Another Device1
- Device Difficult to Setup or Prepare1
- Difficult to Fold, Unfold or Collapse1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information2
- Eye Injury1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 1, 2026Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY HAPTIC PROBLEM WAS IDENTIFIED. BASED ON THE ADDITIONAL INFORMATION PROVIDED, THE EVENT WAS DESCRIBED AS A STRAIGHT HAPTIC PROBLEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT. THERE ARE FIVE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 5 OF 5.
Patient problems: Insufficient Information
MAUDE report 24754695 ↗MalfunctionOct 8, 2024Defective Device; Defective Device
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS IMPLANT PROCEDURE THE SURGEON NOTICED LENS WAS DAMAGED UPON IMPLANTING INTO PATIENTS EYE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20396245 ↗InjurySep 16, 2024Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED THAT TRAILING HAPTIC BROKEN DURING SURGERY. THERE WAS PATIENT CONTACT. FAULTY LENS REMOVED FROM EYE AND NEW LENS INSERTED. HAD TO HAVE A LONGER PROCEDURE AND INCISION EXTENDED TO REMOVE FAULTY IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED
Patient problems: Eye Injury; Insufficient Information
MAUDE report 20226857 ↗MalfunctionAug 6, 2023Device Damaged by Another Device; Device Damaged by Another Device
A HEALTH CARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THERE WERE FOLDS OBSERVED ON THE LENS. THERE WAS NO HARM TO THE PATIENT AND THE LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17467305 ↗MalfunctionJul 14, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse
A FINANCE AND DATA LEAD REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, TWO LENSES HAVE FAILED TO OPEN IN THEATRE YESTERDAY. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED THAT ACCORDING TO THE THEATRE TEAM THE LENS WOULDN¿T OPEN ONCE UNPACKAGED TO THEN PLACE INTO THE PATIENT¿S EYE. SURGERY WAS COMPLETED BY USING ALTERNATIVE LENS. THERE WAS NO PATIENT HARM. NO PRODUCT AVAILABLE FOR RETURN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15011488 ↗MalfunctionDec 27, 2021Defective Component; Defective Component
A NURSE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION THE INJECTOR FAILED. THERE WAS PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13087600 ↗
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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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