TECNIS SIMPLICITY DIB00 (REF DIB00U0050)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474731455), received between Mar 25, 2021 and Sep 16, 2024 — classified as 4 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.

• MalfunctionSep 16, 2024Use of Device Problem; Expiration Date Error; Use of Device Problem; Expiration Date Error

  THE PRE-LOADED DIB00 MODEL INTRAOCULAR LENS (IOL) WAS EXPIRED (14-APR-2024) WHEN IT WAS IMPLANTED IN THE PATIENT'S EYE ON (B)(6) 2024. PATIENT OUTCOME WAS REPORTED AS GOOD, PATIENT CAN SEE WELL, AND NO ISSUES. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT REMAINS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20233601 ↗
• MalfunctionJul 14, 2023Break; Crack; Manufacturing, Packaging or Shipping Problem; Break; Crack; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DIB00 INTRAOCULAR LENS INSERTER TIP SPLIT APART AND INTRAOCULAR LENS CAME OUT AS DAMAGED/DEFECTIVE. THERE WAS NO PATIENT CONTACT AND BACKUP LENS USED TO COMPLETE CASE. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE EVENT WAS OBSERVED UPON PACKAGE OPENING AND THE INNER POUCH WAS OPENED. IT WAS CONFIRMED THAT CARTRIDGE TIP WAS DAMAGED AND SPLIT APART. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17328137 ↗
• MalfunctionJul 14, 2022Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS ADVANCED INTO PATIENT'S RIGHT EYE, HOWEVER, WHEN THE LENS WAS OBSERVED THROUGH MICROSCOPE SURGEON OBSERVED IT WAS CRACKED. THE LENS WAS REMOVED IN PIECES AND A NEW JOHNSON & JOHNSON LENS OF SAME SPECIFICATIONS (SAME DIOPTER AND SIZE) WAS IMPLANTED WITHOUT ANY INCIDENCE. AFTER INSERTER PREP, THERE WAS NO DELAY IN THE SURGERY BEFORE AN ATTEMPT WAS MADE TO ADVANCE THE LENS, NO STUCK LENS AND NOTHING UNUSUAL WAS NOTICED. IT WAS INDICATED THAT ROOM TEMPERATURE BALANCED SALT SOLUTION (BSS) WAS USED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15023296 ↗
• MalfunctionMar 25, 2021Material Opacification; Material Opacification

  IT WAS REPORTED THAT THE DOCTOR IMPLANTED AN INTRAOCULAR LENS AND AFTER IMPLANTING THE LENS, HE NOTICED A DIVOT IN THE ANTERIOR SURFACE OF THE LENS. ONCE THE DOCTOR IDENTIFIED THE DIVOT, HE USED BOTH HIS IRRIGATION/ASPIRATION (I/A) TIP AND 2ND INSTRUMENT TO SEE IF HE COULD REMOVE THE MARK. THE DOCTOR WAS UNABLE TO REMOVE IT AS HE FELT IT WAS INSIDE THE ANTERIOR PORTION OF THE OPTIC. THE DOCTOR WAS TO SEE THE PATIENT ON THE NEXT DAY FOR EVALUATION. REPORTEDLY, THE LENS REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11572943 ↗