AcrySof® UltraSert® ACU0T0 (REF ACU0T0.280)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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652395410), received between May 11, 2021 and Aug 6, 2025 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Defective 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
- Defective Device1
- Device Damaged by Another Device1
- Failure to Unfold or Unwrap1
- Inaccurate Delivery1
- Unintended Ejection1
Patient problems
- Insufficient Information2
- Capsular Bag Tear1
- Eye Injury1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 6, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHILE INJECTING IN THE EYE THE LENS DID NOT UNFOLD. THE SURGERY WAS COMPLETED WITH NEW LENS. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22728219 ↗InjurySep 12, 2023Device Damaged by Another Device; Device Damaged by Another Device
INCISION INCREASED TO 2.75.
Patient problems: Eye Injury; Insufficient Information
MAUDE report 17728424 ↗MalfunctionApr 13, 2022Defective Device; Defective Device
AN IOL REPLY CARD WAS RECEIVED STATED THAT LENS WAS NOT USED DUE TO DEFECT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 14102223 ↗InjuryMay 11, 2021Unintended Ejection; Inaccurate Delivery; Unintended Ejection; Inaccurate Delivery
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, WHILE INSERTING THE IOL, THE POSTERIOR CAPSULAR BAG RUPTURED. IT WAS NOTED THAT THE EYE GAVE A "HORSE KICK" DURING IMPLANTATION. AN ALTERNATE IOL WAS IMPLANTED AND "DISINSERTION" OF THE CAPSULAR BAG OCCURRED.
Patient problems: Capsular Bag Tear
MAUDE report 11809898 ↗
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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