AcrySof® UltraSert® AU00T0 (UDI 00380652394741)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
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Alcon AcrySof UltraSert intraocular lens is a foldable lens pre-loaded in an injector, used to replace the eye's natural lens during cataract surgery. The 27 reports mostly describe delivery problems during surgery: the lens failing to eject or advance from the injector, being hard to prepare, and haptics (the little arms) catching and breaking, with a few reports of inflammation inside the eye. Two injuries were reported and no deaths. There are no recalls naming 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
- 27
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00380652394741), received between May 1, 2018 and Aug 28, 2026 — classified as 2 injuries, 25 malfunctions.
The most frequently reported specific device problem is “Failure to Eject” (7 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Eject7
- Device Difficult to Setup or Prepare4
- Defective Device3
- Failure to Advance3
- Failure to Deliver3
- Break2
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Insufficient Information13
- No Clinical Signs, Symptoms or Conditions11
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Capsular Bag Tear1
- Conjunctivitis1
- Corneal Clouding/Hazing1
- Corneal Edema1
- Endophthalmitis1
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 28, 2026Device Difficult to Setup or Prepare
A healthcare professional reported with a description of defective intraocular lens (IOL).Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50498513 ↗MalfunctionAug 26, 2026Failure to Deliver
A nurse reported that during an intraocular lens (IOL) implant procedure, the lens remained behind the plunger and was not delivered from the device but instead stayed in the cartridge chamber when the plunger was advanced.Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50451356 ↗MalfunctionJul 17, 2026Device Difficult to Setup or Prepare
Patient problems: Insufficient Information
MAUDE report 25856688 ↗MalfunctionJun 12, 2026Failure to Deliver
A HEALTH CARE PROFESSIONAL STATED THAT THE LENS WOULD NOT ADVANCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25488455 ↗MalfunctionApr 21, 2026Device Damaged by Another Device
A HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE TRAILING HAPTIC WAS NOTED TO BE CAUGHT IN THE INJECTOR AND BROKE AT THE DISTAL 3RD DURING AS IT WAS RELEASED FROM THE INJECTOR. ADDITIONAL INFORMATION RECEIVED AND STATED THAT DURING LENS INSERTION OF CATARACT PROCEDURE, THE TRAILING HAPTIC OF THE PRE-LOADED INTRAOCULAR LENS WAS NOTED TO BE CAUGHT IN THE INJECTOR AND BROKE AT THE DISTAL THIRD DURING INJECTION. THE IOL WAS OTHERWISE UNDAMAGED AND CENTERED IN THE STABLE POSITION, SO THE OPERATING SURGEON MADE THE DECISION NOT TO REMOVE IT. PROCEDURE WAS COMPLETED BECAUSE THE IOL WAS UNDAMAGED AND CENTERED IN THE STABLE POSITION. THERE WAS PATIENT CONTACT AND THERE WAS NO PATIENT HARM. IT WAS ALSO STATED THAT THE PATIENT WAS NOT HOSPITALIZED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24942334 ↗MalfunctionJan 30, 2026Failure to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS FAILED TO ADVANCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE INJECTOR FAIL TO ENGAGE THE LENS. THE SURGEON USED A LIKE-FOR-LIKE LENS AND COMPLETED SURGERY.
Patient problems: Insufficient Information
MAUDE report 24222744 ↗MalfunctionJan 1, 2026Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE LENS HAD BECOME NON-STERILE. THERE MAY ALSO HAVE BEEN AN ISSUE WITH THE HAPTIC.
Patient problems: Insufficient Information
MAUDE report 23938856 ↗MalfunctionSep 19, 2025Break; Break
THE NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, THE HAPTIC WAS EXTENDED AND BROKE WHEN ADVANCING THE LENS. THERE WAS NO CONTACT WITH THE PATIENT, AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23093471 ↗MalfunctionAug 7, 2025Failure to Advance; Scratched Material; Failure to Advance; Scratched Material
A NURSE REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IOL WAS NOT ABLE TO DEPLOY AND SCRATCHED THE LENS HAD TO USE ANOTHER REPLACEMENT LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING DURING THE TIME THE INJECTOR WAS BEING DEPLOYED, THE BLUE PLUNGER WAS NOT CONNECTING WITH THE LENS FROM THE SIDE BUT WAS POINTING AT A DOWNWARD ANGLE UNDERNEATH THE LENS. IT WAS NOTICED THEN THAT THE LENS WAS SCRATCHED WITH NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22740200 ↗MalfunctionMay 2, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THE INJECTOR DID NOT DRAG THE LENS PROPERLY AND SURGERY WAS COMPLETED WITH ANOTHER LENS DURING THE INITIAL PROCEDURE AND THERE WAS NO PATIENT CONTACT.
Patient problems: Insufficient Information
MAUDE report 21949032 ↗MalfunctionJan 9, 2025Failure to Advance; Failure to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN WE OPENED THE LENS PACKAGE THE BLUE PLUNGER FELL DOWN AND DOCTOR TRIED PUT THEM BACK IN AND LOAD THE LENS BUT THE PLUNGER GOING OVER THE LENS. THERE ARE MULTIPLE MEDICAL REPORTS ASSOCIATED WITH DIFFERENT EVENTS. THIS FILE IS 5 OF 9.
Patient problems: Insufficient Information
MAUDE report 21111219 ↗MalfunctionNov 6, 2024Failure to Eject; Failure to Eject
ADDITIONAL INFORMATION RECEIVED AND REPORTED THAT THERE WAS NO PATIENT CONTACT AND IMPACT WITH THE IOL.
Patient problems: Insufficient Information
MAUDE report 20618585 ↗MalfunctionApr 22, 2024Failure to Eject; Failure to Eject
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS FAILED TO EJECT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19151284 ↗MalfunctionFeb 12, 2024Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS WOULD NOT UNFOLD. LENS WAS DISCARDED NO PATIENT HARM REPORTED. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18684378 ↗MalfunctionJan 8, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
A PHYSICIAN REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE PHYSICIAN NOTICED A SMALL PIECE OF WHAT HE THINKS COULD POTENTIALLY BE PLASTIC ON THE PATIENTS CORNEA. HE WAS CONCERNED AT THE TIME THAT IT APPEARS LIKE IT COULD BE A PIECE OF PLASTIC OF THE LENS INJECTOR. HE HAS INSPECTED THE INJECTOR UNDER THE MICROSCOPE AND THOUGHT THERE WAS POSSIBLY AN AREA OF SUSPICION BUT WAS UNSURE.HE FLUSHED AREA, WAS UNABLE TO REMOVE FOREIGN BODY BUT DOES NOT BELIEVE WILL CAUSE ISSUE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18462736 ↗MalfunctionDec 19, 2023Failure to Eject; Failure to Eject
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE LENS GOT STUCK IN THE INJECTOR. THE PROCEDURE WAS COMPLETED WITHOUT ANY CONSEQUENCES BUT THE INCISION HAD TO BE CROSSED TWICE TO INSERT AN IMPLANT, WHICH INCREASES THE COMPLICATIONS RISK. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT INCIDENT WAS OCCURRED DURING PROGRESSION OF THE IOL IN THE INJECTION SYSTEM. THE IOL WAS INCORRECTLY POSITIONED IN INJECTOR SINCE THERE WAS RISK OF DAMAGING THE IMPLANT THE SURGERY WAS COMPLETED WITH NEW LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18354551 ↗MalfunctionNov 6, 2023Failure to Eject; Failure to Eject
A HEALTHCARE PROFESSIONAL REPORTED AN INCIDENT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE IN WHICH THE PLUNGER APPEARED TO BYPASS THE LENS AND WAS UNABLE TO PUSH THE LENS OUT. THERE WAS NO HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18072867 ↗MalfunctionMar 8, 2023Defective Component; Failure to Eject; Defective Component; Failure to Eject
A HEALTH PROFESSIONAL REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, FELT RESISTANCE WHEN PUSHING PLUNGER AND PLUNGER DIDN¿T ENGAGE WITH LENS. LENS REMOVED AND NURSE ATTEMPTED TO LOAD INTO CARTRIDGE, ALSO COULD DO DUE TO BENT TRIALING HAPTIC. ANOTHER LENS USED WITHOUT ISSUE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16500910 ↗MalfunctionNov 28, 2022Defective Device; Defective Device
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE LENSES WERE NOT USED ON THE PATIENT. THEREFORE, THIS EVENT NO LONGER MEETS REPORTING REQUIREMENTS.
Patient problems: Insufficient Information
MAUDE report 15867608 ↗MalfunctionOct 27, 2022Break; Defective Device; Failure to Eject; Break; Defective Device; Failure to Eject
A PHYSICIAN REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION WHEN DOCTOR WAS TRYING TO INJECT THE LENS INTO THE CAPSULAR BAG AND WHEN DOCTOR PRESSED THE PLUNGER IT WENT FORWARD AND SUDDENLY THERE WAS JERK AND PLUNGER CAME BACKWARD AND TRAILING HAPTIC WAS BROKEN INSIDE THE DEVICE AND MOVED INTO BAG WITH LEADING HAPTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE SURGERY WAS COMPLETED WITH THE SAME LENS. THERE WAS NO IMPACT TO THE PATIENT AND THE LENS WAS NOT EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15678712 ↗InjurySep 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED ENDOPHTHALMITIS. ADDITIONAL INFORMATION HAS BEEN REQUESTED
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Conjunctivitis; Corneal Clouding/Hazing; Corneal Edema; Endophthalmitis; Eye Pain; Fibrosis; Hypopyon; Swelling/ Edema; Uveitis; Vitreous Floaters
MAUDE report 15411508 ↗MalfunctionJul 31, 2022Defective Device; Defective Device
A HEALTH CARE PROFESSIONAL REPORTED THAT, LENS FOUND TO BE FAULTY.
Patient problems: Insufficient Information
MAUDE report 15136813 ↗MalfunctionDec 22, 2021Failure to Fold; Failure to Fold
A NON-HEALTH PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, IT WAS STATED THAT, INTRAOCULAR LENS WAS NOT FOLDING CORRECTLY. NO FURTHER INFORMATION IS EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13062869 ↗MalfunctionNov 23, 2021Failure to Eject; Failure to Eject
A NURSE REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PLUNGER ADVANCED ABOVE THE LENS. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12863475 ↗InjuryJul 20, 2021Appropriate Device Problem Term/Code Not Available; Physical Resistance/Sticking; Appropriate Device Problem Term/Code Not Available; Physical Resistance/Sticking
A FACILITY REPRESENTATIVE EMAILED ON BEHALF OF A FACILITY REPRESENTATIVE ABOUT AN PRELOADED DEVICE. PER THE SOURCE EMAIL, THE PHYSICIAN REPORTED THAT HE, EXPERIENCED BACK PRESSURE WITH HIS INJECTOR AND THERE WAS SIGNIFICANT RESISTANCE. AFTER CONTINUED ADVANCEMENT, THE INJECTOR PUNCTURED THE PATIENT¿S POSTERIOR CAPSULE, AND THE SURGEON HAD TO COMPLETE AN ANTERIOR VITRECTOMY. ADDITIONAL INFORMATION REQUESTED.
Patient problems: Capsular Bag Tear
MAUDE report 12197457 ↗
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- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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