AcrySof® UltraSert® AU00T0 (UDI 00380652394642)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
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652394642), received between Jun 11, 2024 and Sep 26, 2026 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (1 report).
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 Difficult to Setup or Prepare1
- Failure to Deliver1
- Failure to Eject1
- Failure to Unfold or Unwrap1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Capsular Bag Tear1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 26, 2026Device Difficult to Setup or Prepare
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907628 ↗MalfunctionFeb 26, 2026Failure to Deliver
A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING INTRAOCULAR LENS IMPLANTATION, INJECTOR CAUGHT ON LENS SO COULD NOT PROCEED. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT CONTACT AND NO PATIENT HARM. ADDITIONAL INFORMATION RECEIVED AND STATED PROCEDURE WAS COMPLETED ON THE SAME DAY USING ANOTHER LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24454082 ↗MalfunctionOct 21, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A HEALTH CARE PROFESSIONAL REPORTED THAT LENS WAS NOT UNFOLDING AS EXPECTED WITH NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON SAME DAY BY ANOTHER UNSPECIFIED LENS WITHOUT ANY HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23347017 ↗InjuryAug 29, 2025Material Twisted/Bent; Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE IOL WAS BEING INSERTED, THE LEADING HAPTIC CAME OUT STRAIGHT AND CAUSED POSTERIOR CAPSULAR RUPTURE. THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND REPLACED WITH SULCUS LENS. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Capsular Bag Tear
MAUDE report 22922886 ↗MalfunctionJun 11, 2024Failure to Eject; Failure to Eject
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, WHEN THE SURGEON ATTEMPTED INSERTION, THE PLUNGER WENT OVER THE LENS AND DID NOT DEPLOY THE LENS AS REQUIRED. THE SURGERY WAS COMPLETED USING ANOTHER LENS OF SAME SPECIFICATIONS. THERE WAS NO PATIENT HARM. ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED, THE SURGEON ATTEMPTED TO RELEASE THE LENS INTO THE PATIENT'S EYE AND THERE WAS NO HARM DONE TO THE PATIENT DESPITE THE FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19508378 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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