AcrySof® UltraSert® ACU0T0 (REF ACU0T0.190)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 16, 2026 from official FDA records · Editorial policy
Quick summary
This Alcon AcrySof UltraSert intraocular lens is implanted in the eye during cataract surgery. Reports mostly describe problems preparing the preloaded injector and placing the lens, including lenses that would not release, arms that bent, broke or caught, and one lens that later shifted and was replaced. There are 23 reports that name its identifier, with no deaths and 2 injuries mentioned. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00380652395236), received between May 6, 2021 and Sep 11, 2026 — classified as 2 injuries, 20 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (9 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Difficult to Setup or Prepare9
- Device Damaged by Another Device3
- Failure to Deliver3
- Failure to Eject3
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Defective Component1
Patient problems
- Insufficient Information12
- No Clinical Signs, Symptoms or Conditions9
- Visual Disturbances1
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2026Device Difficult to Setup or Prepare
A health care professional reported that during an intraocular lens (IOL) implant procedure, lens cannot load properly and going in a different direction. It was very difficult.Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50735964 ↗MalfunctionApr 1, 2026Break; Device Damaged by Another Device
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC BROKE AND LENS NOT USABLE. THERE WAS NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED BY OPENING ANOTHER LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24761299 ↗MalfunctionMar 30, 2026Device Difficult to Setup or Prepare
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS PROBLEM WITH THE HAPTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE PROBLEM WAS DESCRIBED AS STRAIGHT HAPTIC PROBLEM. THERE ARE FIVE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 1 OF 5.
Patient problems: Insufficient Information
MAUDE report 24729454 ↗MalfunctionMar 26, 2026Device Difficult to Setup or Prepare
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS PROBLEM WITH THE HAPTIC. THERE ARE FIVE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 3 OF 5. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THAT THE LENS HAD STRAIGHT HAPTIC PROBLEM. OUT OF FIVE LENSES ONE PATIENT HAD VITRECTOMY BECAUSE OF THE LENS. THE SURGEON SEEN THE LENS ALRIGHT BUT THE BACK HAPTIC WAS STRAIGHT, HE NOTICED IT ONLY WHEN THE LENS INSIDE. SO, HE HAD TO TAKE IT OUT AND ENDED WITH VITRECTOMY. THE DETAILS ABOUT THE PATIENT WHO HAD VITRECTOMY AMONG THESE LENSES ARE UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 24697403 ↗InjuryFeb 3, 2026Device Dislodged or Dislocated
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS SUBLUXED. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS MODEL 39 MONTHS AND 28 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24247471 ↗MalfunctionJan 2, 2026Device Difficult to Setup or Prepare; Material Twisted/Bent
ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE STRAIGHT LEADING HAPTIC WAS OBSERVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23944043 ↗MalfunctionDec 19, 2025Device Difficult to Setup or Prepare; Device Damaged by Another Device; Device Difficult to Setup or Prepare; Device Damaged by Another Device
A HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC GOT CAUGHT WHILE ADVANCING THE LENS WITH THE BLUE PLUNGER, RESULTING IN THE LENS HAPTIC SNAPPING OFF. ANOTHER LENS HAD TO BE USED, AND THE HAPTIC REMAINS CAUGHT IN THE TIP. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23851049 ↗MalfunctionNov 18, 2025Device Damaged by Another Device; Device Damaged by Another Device
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION SURGERY, NOTICED THAT THE LOOP WAS BROKEN IN THE PRELOADED SYSTEM AND THE LENS IMPLANTED WITHOUT LOOP. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT UPON INJECTION INTO THE ANTERIOR CHAMBER, THE IOL (INTRAOCULAR LENS) OPENED, BUT A LOOP WAS CUT AND CLEARLY SEPARATED AT THE BASE OF THE PLATE. SO THEY HAVE FOLLOWED UP WITH THE PATIENT, AND SUBSEQUENT CHECKUPS SHOWED NO PROBLEMS. THE IOL WAS IN THE CAPSULAR BAG, AND SINCE THE PATIENT WAS SATISFIED AND HAS NOT PRESENTED ANY SYMPTOMS OR COMPLAINTS, THE IOL WILL NOT BE EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23583036 ↗MalfunctionOct 22, 2025Failure to Deliver; Failure to Deliver
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THERE WAS A PROBLEM WITH THE LENS, IT COULD NOT BE ADVANCED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23359636 ↗MalfunctionOct 15, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED THAT, WITH A DESCRIPTION OF DEFECTIVE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23301384 ↗MalfunctionSep 4, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, TRAILING HAPTIC FOLDED WRONG. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22961473 ↗MalfunctionJul 30, 2025Failure to Deliver; Failure to Deliver
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS STUCK IN THE INJECTOR. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT IMPACT OR HARM. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, THE PROCEDURES WERE COMPLETED WITHOUT HARM TO THE PATIENT USING A DIFFERENT NEW LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22664848 ↗MalfunctionJun 20, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON-HEALTH CARE PROFESSIONAL NOTICED THAT THE RECEIVED, IOL (INTRAOCULAR LENS) WAS DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22301329 ↗MalfunctionMay 6, 2025Device Difficult to Setup or Prepare; Failure to Advance; Device Difficult to Setup or Prepare; Failure to Advance
A HEALTHCARE PROFESSIONAL REPORTED THAT BEFORE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PLUNGER OVERSHOT LENS IN CARTRIDGE AND THERE WAS LEADING HAPTIC ISSUE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITH UNSPECIFIED REPLACEMENT IOL. THERE WAS NO PATIENT CONTACT AND HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21968854 ↗MalfunctionNov 16, 2023Failure to Eject; Failure to Eject
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING THE INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS GOT STUCK TO THE INJECTOR AND COULD NOT BE IMPLANTED.
Patient problems: Insufficient Information
MAUDE report 18147251 ↗MalfunctionMay 4, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
AN OPHTHALMIC SURGEON REPORTED ABOUT A FIBER WITHIN THE IOL WAS NOTICED AFTER INTRAOCULAR LENS IMPLANTATION WHICH WAS NOT VISUALLY SIGNIFICANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING IN SURGEON'S OPINION, THE FIBER IN LENS WAS DURING THE MANUFACTURING PROCESS.
Patient problems: Insufficient Information
MAUDE report 16867116 ↗MalfunctionJun 14, 2022Failure to Eject; Failure to Eject
A NURSE REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL), PLUNGER WENT OVER THE LENS. THERE WAS PATIENT CONTACT AND NO PATIENT HARM. THE SURGERY COMPETE ON SAME DAY WITH BACK UP LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14686108 ↗MalfunctionApr 29, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A FACILITY REPRESENTATIVE REPORTED THAT DURING IMPLANTATION OF INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS A LOADING ERROR. THE PATIENT CONTACT WAS NOTED. THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 14250517 ↗InjuryFeb 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT FELT LIKE A SHADOW FOLLOWING HER AND THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE WITH NON COMPANY LENS. ADDITIONAL INFORMATION WAS RECEIVED STATING THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT AND THERE WAS NO PATIENT HARM.
Patient problems: Visual Disturbances
MAUDE report 13582928 ↗MalfunctionOct 28, 2021Failure to Eject; Failure to Eject
A FACILITY REPRESENTATIVE REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS STUCK IN INJECTOR WITH PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 12712025 ↗MalfunctionSep 15, 2021Defective Component; Defective Component
A PURCHASING AGENT REPORTED DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION THE TIP WAS MESSED UP AND STILL THE SURGEON WAS ABLE TO USE IT. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12477190 ↗MalfunctionMay 6, 2021Failure to Deliver; Failure to Deliver
A HEALTH PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE PLUNGER WENT OVER THE LENS. THE DEVICE WAS EXCHANGED TO COMPLETE THE CASE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11782947 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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