TECNIS SIMPLICITY DIB00 (REF DIB00U0270)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474731905), received between Dec 1, 2021 and Jul 21, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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.

• MalfunctionJul 21, 2023Break; Break

  IT WAS REPORTED THAT THE PRE-LOADED DIB00 INTRAOCULAR LENS (IOL) HAPTIC WAS BROKEN WHEN ATTEMPTING TO INSERT INTO THE EYE. BOTH THE INSERTER AND LENS TOUCHED EYE. THERE WERE NO PATIENT INJURY AND NO MEDICAL OR SURGICAL INTERVENTIONS REQUIRED. PHYSICIAN USED ANOTHER IOL OF SAME MODEL AND DIOPTER TO COMPLETE THE PROCEDURE. THE PRODUCT IS BEING RETURNED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17374537 ↗
• InjuryApr 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A CAPSULE TEAR THAT REQUIRED A VITRECTOMY DURING A PRELOADED INTRAOCULAR LENS (IOL) IMPLANTATION IN THE PATIENT'S OPERATIVE EYE. AN ALTERNATE LENS WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 14224411 ↗
• MalfunctionDec 6, 2021Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) FROM A PRELOADED PRODUCT WAS IMPLANTED AND EXPLANTED. IT WAS LEARNED THAT THE EVENT OCCURRED DURING THE SAME PROCEDURE. IOL WAS REMOVED DUE TO HAPTIC MAY HAVE BEEN DAMAGED WHEN THE LENS WAS ADVANCED IN THE CARTRIDGE. DID NOT FOLD THE WAY IT USUALLY DOES. THE DOCTOR DID NOT LIKE THE LOOK OF THE FRONT HAPTIC WHEN THE LENS STARTED COMING OUT. THE INCISION WAS ENLARGED SLIGHTLY FOR THE CARTRIDGE SIZE. THE BACK UP IOL OF THE SAME MODEL AND DIOPTER SIZE WAS IMPLANTED INSTEAD. THE SUSPECT PRODUCT IS UNAVAILABLE FOR RETURN. NO VISUAL ISSUES. THERE WAS NO PATIENT POST-OP INJURY. NO OTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12934658 ↗
• MalfunctionDec 1, 2021Difficult to Fold, Unfold or Collapse; Material Fragmentation; Inaccurate Delivery; Difficult to Fold, Unfold or Collapse; Material Fragmentation; Inaccurate Delivery

  IT WAS REPORTED THAT THE HAPTIC OF AN INTRAOCULAR LENS (IOL) GOT STUCK UNDER THE PUSH BAR AND RIPPED THE HAPTIC AS IT WAS BEING PULLED OUT OF THE INJECTOR. THE DOCTOR HAD TO GO INSIDE THE EYE AND AMPUTATE THE DISTAL END OF THE STUCK HAPTIC FROM THE INJECTOR. THE EDGE WAS SMOOTH AND THEREFORE THE DECISION WAS MADE TO CONTINUE IMPLANTING THE IOL IN THE BAG AND THE LENS WAS LEFT IN THE RIGHT EYE OF THE PATIENT WITHOUT A HAPTIC. IT WAS INDICATED THAT AFTER INSERTION, THEY COULD NOT GET THE INJECTOR OUT, BECAUSE THE HAPTIC WAS UNDER THE PUSH BAR. THE SURGERY TECH THINKS THAT AT THE TIME OF MANUFACTURING WHEN THE LENSES ARE LOADED, THE BACK HAPTIC TRAILS BACK. THE LENS WITH ONLY ONE HAPTIC REMAINS IMPLANTED AS OF TO DATE AND NO SECONDARY SURGICAL PROCEDURE HAS BEEN PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12913638 ↗