TECNIS SIMPLICITY DIB00 (REF DIB00U0295)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474731950), received between Nov 6, 2023 and Apr 17, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 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.

• MalfunctionApr 17, 2026Break

  IT WAS REPORTED THAT ONE HAPTIC OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL DIB00, APPEARED MALFORMED. PATIENT CONTACT OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24913751 ↗
• InjuryJul 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN EYHANCE INTRAOCULAR LENS (IOL) WAS EXPLANTED. IT WAS LEARNED THAT THE DOCTOR INSERTED THE IOL BUT BAG WAS UNSTABLE. THE DOCTOR THEN REMOVED THE IOL. BUT PATIENT LEFT APHAKIC, CONTACT PERSON DOESN'T KNOW WHY, BUT PATIENT WAS REFERRED TO A RETINA SPECIALIST. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 19779708 ↗
• InjuryNov 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THE PATIENT MOVED AND THE PRELOADED INTRAOCULAR LENS (IOL) HAD TO BE REMOVED. THERE WAS PATIENT CONTACT WITH THE PRODUCT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 18127117 ↗
• MalfunctionNov 6, 2023Contamination; Contamination

  IT WAS REPORTED THAT THE LENS SEEMED TO HAVE A PIECE OF LINT OR DUST ON IT UPON IMPLANT INTO THE PATIENT¿S EYE. THE SURGEON INFORMED THAT SHE WAS ABLE TO PHACO THE MATERIAL OFF OF THE LENS, BUT IT SHOULD NOT BE THERE IN THE FIRST PLACE.  THE LENS IS STILL IMPLANTED. THERE WAS NO INJURY, AND SURGICAL AND MEDICAL INTERVENTIONS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18077007 ↗