AcrySof® UltraSert® ACU0T0 (REF ACU0T0.180)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
- 19
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00380652395212), received between Jun 21, 2022 and May 20, 2026 — classified as 1 injury, 18 malfunctions.
The most frequently reported specific device problem is “Device Damaged by Another Device” (4 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 Damaged by Another Device4
- Failure to Eject4
- Defective Device3
- Failure to Advance3
- Device Difficult to Setup or Prepare2
- Failure to Deliver2
- Failure to Unfold or Unwrap2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Insufficient Information12
- No Clinical Signs, Symptoms or Conditions8
- Eye Injury1
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 20, 2026Device Damaged by Another Device
A HEALTHCARE PROFESSIONAL REPORTED BEFORE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTICS WAS FOUND TO BE CUT OFF FROM THE PISTON. THERE WAS NO PATIENT CONTACT. THE IOL WAS DISCARDED AND NEW ONE WAS IMPLANTED. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED, YET NO NEW INFORMATION WAS RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25229272 ↗MalfunctionMay 18, 2026Failure to Deliver; Failure to Advance
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATED THAT THERE WAS NO PATIENT CONTACT WITH THE DEVICE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 25201247 ↗MalfunctionApr 9, 2026Failure to Unfold or Unwrap
A HEALTHCARE PROFESSIONAL REPORTED WITH THE DESCRIPTION THAT THE LENSES WOULD NOT UNFOLD AND COULD NOT BE IMPLANTED IN THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24832081 ↗MalfunctionJan 12, 2026Device Difficult to Setup or Prepare
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WAS NOT IN POSITION. THE SURGERY WAS COMPLETED ON THE SAME DAY AND THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24034493 ↗MalfunctionSep 9, 2025Device Damaged by Another Device; Device Damaged by Another Device
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS CAME OUT DEFORMED FROM THE INJECTOR AND COULD NOT BE USED. A REPLACEMENT LENS WAS UTILIZED INSTEAD. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23005538 ↗MalfunctionJun 19, 2025Failure to Deliver; Failure to Advance; Failure to Deliver; Failure to Advance
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE THE PLUNGER WENT OVER THE LENS AND IT DIDN¿T COME OUT. THE PROCEDURE WAS COMPLETED WITH THE REPLACEMENT LENS. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THERE WAS A PATIENT CONTACT AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22292397 ↗MalfunctionMay 23, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTH CARE PROFESSIONAL REPORTED ABOUT A DEFECTIVE DEVICE. NO OTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 22079041 ↗MalfunctionFeb 11, 2025Break; Failure to Advance; Break; Failure to Advance
A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION, PLUNGER DID NOT ENGAGE CORRECTLY AND HAPTIC WAS MISSING PART OF THE HAPTIC OR BROKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21355142 ↗MalfunctionNov 28, 2024Device Damaged by Another Device; Failure to Eject; Device Damaged by Another Device; Failure to Eject
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, PLUNGER WENT OVER THE LENS OR PLUNGER OVER RIDE OR PLUNGER BY PASSED THE IOL AND DID NOT DEPLOY AND LENS WAS DAMAGED DUE TO PLUNGER RUN OVER TOP OF LENS INSTEAD OF PUSHING THE LENS OUT. ADDITIONAL INFORMATION WAS REQUESTED. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 1 OF 3.
Patient problems: Insufficient Information
MAUDE report 20805912 ↗MalfunctionNov 15, 2024Failure to Eject; Failure to Eject
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF THE INTRAOCULAR LENS GOT BLOCKED IN THE INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20692581 ↗MalfunctionMay 10, 2024Defective Device; Defective Device
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF THE (IOL) INTRAOCULAR LENS BEING DEFECTIVE. ADDITIONAL INFORMATION WAS REQUESTED BUT NO FURTHER INFORMATION WAS RECEIVED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 2 OF 2.
Patient problems: Insufficient Information
MAUDE report 19285531 ↗MalfunctionApr 18, 2024Failure to Unfold or Unwrap; Device Damaged by Another Device; Failure to Unfold or Unwrap; Device Damaged by Another Device
A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF HAPTICS SEEMED TO BE AMALGAMATED WITH THE INTRAOCULAR LENS (IOL) AND THE LENS ITSELF WAS ALMOST MANGLED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19132545 ↗MalfunctionDec 28, 2023Failure to Eject; Failure to Eject
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THERE WAS A SLIGHT ISSUE YESTERDAY IN THEATRE 2 . HE NEEDED AN 18.0D LENS, BUT THE FIRST TWO THAT HE TRIED WERE UNSUCCESSFULLY USED. APPARENTLY, THE CARTRIDGE JAMMED. THEY WERE PUT INTO THE EYE SO ARE CONTAMINATED. THE THIRD ONE WAS SUCCESSFULLY IMPLANTED. THE FIRST ONE HAD BEEN IN THE WARMING CABINET, BUT UNSUCCESSFUL 2 AND SUCCESSFUL 3 WERE BOTH STRAIGHT FROM THE SHELF, SO NO CLUE AS TO WHY IT HAPPENED. THE FAULTY LENSES HAVE BEEN PUT TO ONE SIDE AND WRAPPED UP SECURELY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18415776 ↗MalfunctionDec 28, 2023Failure to Eject; Failure to Eject
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THERE WAS A SLIGHT ISSUE YESTERDAY IN THEATRE 2 . HE NEEDED AN 18.0D LENS, BUT THE FIRST TWO THAT HE TRIED WERE UNSUCCESSFULLY USED. APPARENTLY, THE CARTRIDGE JAMMED. THEY WERE PUT INTO THE EYE SO ARE CONTAMINATED. THE THIRD ONE WAS SUCCESSFULLY IMPLANTED. THE FIRST ONE HAD BEEN IN THE WARMING CABINET, BUT UNSUCCESSFUL 2 AND SUCCESSFUL 3 WERE BOTH STRAIGHT FROM THE SHELF, SO NO CLUE AS TO WHY IT HAPPENED. THE FAULTY LENSES HAVE BEEN PUT TO ONE SIDE AND WRAPPED UP SECURELY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18408911 ↗MalfunctionAug 2, 2023Defective Device; Defective Device
A HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INTRAOCULAR LENS CAME DEFECTIVE INTO THE EYE DURING IMPLANTATION.ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17441182 ↗MalfunctionMay 17, 2023Defective Component; Material Twisted/Bent; Defective Component; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING LOADING REAR HAPTIC WAS BENT. THERE WAS NO PATIENT CONTACT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16945239 ↗MalfunctionDec 14, 2022Unintended Ejection; Difficult to Advance; Unintended Ejection; Difficult to Advance
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, CAME OUT OF THE INJECTOR WITH ROTATED HAPTICS, OPTIC COMING OUT ROTATED AND SHOOTING OUT OF THE INJECTOR. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15977259 ↗InjuryOct 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE CUTTING SIZE OF 2.2 MM WILL NOT WORK WITHOUT CUTTING THE EXPANSION OF 2.4 MM, IN A CATARACT SURGERY A CUT EXPANSION WAS PERFORMED, AND THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATED THAT THERE WAS NO IMPAIRMENT AS A RESULT OF THE EVENT. THERE ARE 4 REPORTS, THIS IS 3 OF 4 REPORTS.
Patient problems: Eye Injury
MAUDE report 15620692 ↗MalfunctionJun 21, 2022Defective Device; Defective Device
A NURSE REPORTED WITH A DESCRIPTION OF FAULTY INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 14753199 ↗
Other intraocular lens devices
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- 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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