AcrySof® UltraSert® AU00T0 (UDI 00380652394666)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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652394666), received between Jun 24, 2021 and Sep 15, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Failure to Eject” (3 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 Eject3
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Device Difficult to Setup or Prepare1
- Failure to Advance1
- Failure to Fold1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026Device Difficult to Setup or Prepare
A healthcare professional reported that during cataract surgery, the haptic became dislodged during implantation of the intraocular lens (IOL) in the patient's left eye. The surgery was completed using a replacement lens. There was no patient harm. The surgery was delayed by 5 minutes due to the event.No further details are expected, as the reporter has no more information available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50772569 ↗MalfunctionJan 8, 2026Failure to Fold
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS DID NOT UNFOLD PROPERLY AT TIP PF PLUNGER AND APPEARED STUCK TOGETHER AT THE END OF THE PLUNGER WHEN IT WAS ATTEMPTED TO INSERT. IT WAS REPORTED THAT SURGEON MADE CONTACT WITH PATIENT EYE READY FOR THE IMPLANT BUT IT WAS UNABLE TO PROCEED AS IT WAS NOT UNROLLED EFFECTIVELY READY FOR THE CORRECT PLACEMENT AS IT WAS ATTEMPTED INSERTION. IT WAS ALSO STATED THAT THE ISSUE WAS IDENTIFIED WHEN SURGEON WAS ATTEMPTING TO INSERT AND REMOVED IT SAFELY AS THE LENS WAS STILL IN THE PLUNGER AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24003883 ↗MalfunctionMay 27, 2025Break; Break
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED THAT THE DISTAL HAPTIC WAS ALMOST DETACHED. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE AND IMPLANTED ANOTHER UNSPECIFIED LENS WITHOUT ANY ADDITIONAL PROBLEMS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22086329 ↗MalfunctionSep 11, 2024Failure to Eject; Failure to Eject
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS LOADED ACCORDING TO THE INSTRUCTIONS, YET THE PLUNGER DID NOT STICK TO THE LENS; IT TURNED SIDEWAYS AND ENDED UP ON TOP OF THE LENS. THE SITUATION WAS RESOLVED BY USING A NEW UNSPECIFIED LENS. NO HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20189196 ↗MalfunctionMay 29, 2023Failure to Eject; Failure to Eject
A OTHER HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INJECTOR WOULD NOT ENGAGE THE LENS AND ALLOW IT TO BE IMPLANTED. THERE WAS PATIENT CONTACT WITH THE DEVICE BUT NOT THE IOL. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE LENS. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17017195 ↗MalfunctionJun 24, 2021Failure to Advance; Appropriate Device Problem Term/Code Not Available; Failure to Eject; Failure to Advance; Appropriate Device Problem Term/Code Not Available; Failure to Eject
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE LENS GET STUCK IN INJECTOR AND SYRINGE WENT OVER THE LENS. THERE WAS PATIENT CONTACT BUT NO PATIENT HARM REPORTED. THE REPORTER IS UNWILLING TO PROVIDE FURTHER INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12055986 ↗
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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