AcrySof® UltraSert® AU00T0 (UDI 00380652394932)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
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652394932), received between Mar 19, 2021 and Oct 15, 2025 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Device Damaged by Another Device” (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 Damaged by Another Device1
- Device Difficult to Setup or Prepare1
- Failure to Align1
- Failure to Eject1
- Material Too Rigid or Stiff1
- Unintended Ejection1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Capsular Bag Tear1
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2025Device Difficult to Setup or Prepare; Device Damaged by Another Device; Device Difficult to Setup or Prepare; Device Damaged by Another Device
A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE HAPTIC OF THE LENS WAS TIGHTLY WEDGED BETWEEN THE PLUNGER AND CARTRIDGE. AND THE HAPTIC BROKE OFF. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23279323 ↗MalfunctionNov 8, 2023Unintended Ejection; Unintended Ejection
A NURSE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS CAME WRONG OUT FROM THE INJECTOR. THE PROCEDURE WAS COMPLETED WITH THE REPLACEMENT LENS. THERE WAS PATIENT CONTACT BUT SURGEON REMOVED IT WITH NO COMPLICATIONS. THE RE IS NO PATIENT ARM REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18091902 ↗InjuryMay 13, 2023Failure to Align; Failure to Eject; Failure to Align; Failure to Eject
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS OVERSHOT WHEN IMPLANTING IN TO THE EYE, WHICH RESULTED IN PENETRATION OF THE PATIENT'S THE POSTERIOR CAPSULE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, THE FAULTY IOL DAMAGED THE CAPSULAR BAG SO THE ORIGINAL PROCEDURE WAS ABANDONED AND ALTERNATIVE INSTIGATED. THE SURGEON HAD DONE ANTERIOR VITRECTOMY AND EXPLANT OF FAULTY IOL AND ALTERNATIVE 3 PIECE IOL PLACED IN SULCUS. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT.
Patient problems: Capsular Bag Tear
MAUDE report 16925335 ↗MalfunctionMar 19, 2021Material Too Rigid or Stiff; Material Too Rigid or Stiff
A CUSTOMER REPORTED THE PLUNGER OF A PRELOADED INTRAOCULAR LENS (IOL) DELIVERY SYSTEM WAS STIFF. THERE WAS NO REPORTED PATIENT IMPACT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 11530921 ↗
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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