TECNIS SIMPLICITY DCB00 (REF DCB0000305)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474636293), received between Aug 19, 2025 and Dec 13, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2025Break; Break

  IT WAS REPORTED THAT TWO INTRAOCULAR LENSES (IOL) WERE FOUND DEFECTIVE. THE ISSUE OCCURRED DURING A PROCEDURE WHEN THE LENSES WERE PUSHED INTO THE INJECTOR, RESULTING IN BOTH LENSES BECOMING TWISTED. THE LENSES AND THE CARTRIDGE TIPS MADE CONTACT WITH THE PATIENT'S EYE DURING THE PROCEDURE. THE PATIENTS WERE NOT AFFECTED. THE IOLS WERE DISCARDED. NO FURTHER INFORMATION HAS BEEN PROVIDED. NOTE: THIS REPORT IS TO CAPTURE THE EVENT OF ONE OF THE TWO DEVICES. A SEPARATE REPORT IS BEING SUBMITTED TO CAPTURE THE OTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23798691 ↗
• MalfunctionDec 13, 2025Break; Break

  IT WAS REPORTED THAT TWO INTRAOCULAR LENSES (IOL) WERE FOUND DEFECTIVE. THE ISSUE OCCURRED DURING A PROCEDURE WHEN THE LENSES WERE PUSHED INTO THE INJECTOR, RESULTING IN BOTH LENSES BECOMING TWISTED. THE LENSES AND THE CARTRIDGE TIPS MADE CONTACT WITH THE PATIENT'S EYE DURING THE PROCEDURE. THE PATIENTS WERE NOT AFFECTED. THE IOLS WERE DISCARDED. NO FURTHER INFORMATION HAS BEEN PROVIDED. NOTE: THIS REPORT IS TO CAPTURE THE EVENT OF ONE OF THE TWO DEVICES. A SEPARATE REPORT IS BEING SUBMITTED TO CAPTURE THE OTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23798690 ↗
• MalfunctionAug 19, 2025Break; Break

  IT WAS REPORTED THAT PRELOADED MONOFOCAL INTRAOCULAR LENS WAS DEFECTIVE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22845806 ↗
• MalfunctionAug 19, 2025Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS NOT USED, THE LENS WAS CRUNCHED UP AND THE SURGEON SUSPECTED THE IOL WAS NOT LOADED PROPERLY. THE IOL WAS NOT USED OR INSERTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22845803 ↗