TECNIS SIMPLICITY DIB00 (REF DIB00U0265)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474731899), received between Mar 10, 2022 and Mar 30, 2026 — classified as 2 injuries, 1 malfunction.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO THE PATIENT EXPERIENCING A MYOPIC SURPRISE POST IMPLANTATION IN THE RIGHT EYE. DURING THE POST-OPERATIVE EXAMINATION, THE REFRACTIVE OUTCOME WAS RECORDED AS OD -1.00 +1.25 X 74. THE LENS WAS SUBSEQUENTLY EXPLANTED DURING A SECONDARY SURGERY ON THE SAME DAY. IT WAS CONFIRMED THAT NO VITRECTOMY WAS PERFORMED. IT IS UNCLEAR WHETHER THE INCISION WAS ENLARGED OR IF SUTURES WERE NECESSARY. THE PATIENT'S STATUS AND THE IMPACT ON THEIR DAILY ACTIVITIES REMAIN UNKNOWN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 24721520 ↗
• MalfunctionMay 8, 2023Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DAMAGED. THE SCRUB NURSE ENGAGED THE LENS AND FORWARDED TO THE SURGEON. THE SURGEON OBSERVED THAT THE IOL IS BROKEN AND DID NOT ATTEMPT TO INSERT THE LENS; HOWEVER, THE CARTRIDGE TIP CONTACTED THE EYE. THE SCRUB NURSE VERIFIED THAT THE LENS IS DEFECTIVE. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16888505 ↗
• InjuryMar 10, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO DISLOCATION OF THE IOL IN THE PATIENT'S LEFT EYE. A VITRECTOMY WAS REQUIRED. ANOTHER JOHNSON & JOHNSON LENS, (DIFFERENT MODEL, ZA9003, AND LOWER DIOPTER, 25.5) WAS IMPLANTED AS THE REPLACEMENT. THERE WAS NO PATIENT INJURY. THE PATIENT IS DOING GOOD POST-OPERATIVELY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13717877 ↗