AcrySof® UltraSert® ACU0T0 (REF ACU0T0.150)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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652395151), received between Apr 12, 2021 and May 13, 2026 — classified as 1 injury, 6 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (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
- Failure to Advance2
- Failure to Eject2
- Material Discolored2
- Device Damaged by Another Device1
Patient problems
- Insufficient Information4
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 13, 2026Failure to Advance
A HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PLUNGER DID NOT CATCH THE LENS, BYPASSED IT AND LENS WAS UNABLE TO ADVANCE. IT WAS STATED THAT THE PROCEDURE WAS COMPLETED USING ANOTHER LENS. ADDITIONAL INFORMATION RECEIVED AND STATED THAT NO INJURY SUSTAINED DURING INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25157643 ↗MalfunctionJul 17, 2025Failure to Advance; Failure to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS PLUNGER MOVED FORWARD WITHOUT ENGAGING THE IOL WITH IT. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22538947 ↗MalfunctionMay 16, 2025Material Discolored; Material Discolored
A HEALTHCARE PROFESSIONAL REPORTED THAT AFTER SURGERY, THEY NOTICED A QUITE PRONOUNCED CLOUDY LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE IS FOR RIGHT EYE.
Patient problems: Insufficient Information
MAUDE report 22034704 ↗InjuryApr 29, 2025Material Discolored; Material Discolored
A HEALTH CARE PROFESSIONAL REPORTED THAT AFTER A CATARACT SURGERY, THEY NOTICED THAT THE SURGEON HAD A PATIENT WITH AN IOL IMPLANTED IN 2020 THAT NOW HAD TURNED WHITE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT, ON (B)(6) 2020, CATARACT OPERATION PERFORMED ON LEFT EYE WHICH WAS UNCOMPLICATED. ON (B)(6) 2020, LENS RESIDUE REMOVED FROM ANTERIOR CHAMBER. ON (B)(6) 2020, CATARACT OPERATION PERFORMED ON LEFT EYE WHICH WAS UNCOMPLICATED. ON (B)(6) 2023, YAG MEMBRANEECTOMY WAS PERFORMED ON LEFT EYE. SLIGHTLY CLOUDY IOL WAS NOTED HERE ON BOTH SIDES. ON (B)(6) 2025, YAG MEMBRANEECTOMY WAS PERFORMED ON LEFT EYE. SECONDARY CATARACT SURGERY WITH CAPSULAR BAG DISTENSION SYNDROME. QUITE PRONOUNCED CLOUDY IOL IN BOTH EYES, PRIMARILY LEFT EYE WAS NOTED. THE PATIENT HAD BEEN OFFERED REMOVAL OF A FAIRLY CLOUDY IOL FOR THE LEFT EYE, BUT HAD NOT YET REQUESTED IT. THERE ARE TWO BILATERAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO LEFT EYE.
Patient problems: Insufficient Information
MAUDE report 21925121 ↗MalfunctionNov 15, 2024Failure to Eject; Failure to Eject
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PLUNGER OF THE PRE-LOADED IOL DID NOT ENGAGE WITH THE DISTAL PORTION OF THE IOL WHEN ADVANCED AND BYPASSED THE IOL. THE IOL WAS PRIMED IN ROOM TEMPERATURE. THE PLUNGER WAS THEN RETRACTED AND ANOTHER ATTEMPT TO ENGAGE WITH THE IOL WAS MADE WITHOUT SUCCESS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20698424 ↗MalfunctionNov 24, 2023Failure to Eject; Failure to Eject
A HEALTHCARE PROFESSIONAL REPORTED THAT THE LENS GET STUCK IN THE CHAMBER AND BE UNABLE TO IMPLANT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18204706 ↗MalfunctionApr 12, 2021Device Damaged by Another Device; Device Damaged by Another Device
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS NOTED TO BE SCRATCHED. ALTHOUGH THERE WAS PATIENT CONTACT,THE PROCEDURE WAS COMPLETED WITH ANOTHER LENS WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11651704 ↗
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.
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