TECNIS SIMPLICITY DIB00 (REF DIB00U0145)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474731646), received between Dec 1, 2022 and Aug 27, 2026 — 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.

• InjuryAug 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the preloaded monofocal intraocular lens (IOL) was implanted in the patient's right eye. During a postoperative examination, the patient experienced refractive surprise. The lens was explanted during a secondary surgical procedure and replaced with another DIB00 intraocular lens of the same model with a diopter power of +18.5. No incision enlargement, vitrectomy, or sutures were required during the procedure. No additional information was provided.

  Patient problems: Visual Impairment

  MAUDE report 50481141 ↗
• MalfunctionJan 22, 2025Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) HAD A DAMAGED LEADING HAPTIC. DURING THE PROCEDURE, THERE WAS PATIENT CONTACT WITH THE IOL, WHICH WAS SUBSEQUENTLY REPLACED WITH AN IOL OF THE SAME MODEL AND DIOPTER. ADDITIONAL INFORMATION INDICATES THAT THE LEADING HAPTIC WAS DAMAGED UPON INSERTION, BUT THE LENS WAS NOT IMPLANTED. THERE WAS NO INJURY OR FURTHER INTERVENTION REQUIRED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21209638 ↗
• MalfunctionDec 22, 2023Break; Crack; Failure to Advance; Break; Crack; Failure to Advance

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAD A ADVANCEMENT ISSUE. THERE WAS NO PATIENT CONTACT. IT WAS ALSO REPORTED THE CARTRIDGE BURST OPEN WHILE TRYING TO INSERT THE LENS. A BACK UP LENS WAS USED. IT IS UNCLEAR IF THERE WAS PATIENT CONTACT OR NOT. THE LENS WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18386097 ↗
• MalfunctionDec 1, 2022Crack; Material Too Rigid or Stiff; Crack; Material Too Rigid or Stiff

  IT WAS REPORTED THAT THE SURGEON WAS TRYING TO TURN THE PLUNGER OF THE PRELOADED DEVICE, BUT IT WAS GIVING RESISTANCE AND THE END OF THE CARTRIDGE SPLIT OPEN. ADDITIONAL INFORMATION RECEIVED REVEALED THAT THE CARTRIDGE CRACKED WHEN THE LENS WAS BEING ADVANCED. THE LENS WAS NOT INSERTED INTO PATIENT'S LEFT EYE, BUT ONLY THE CARTRIDGE TIP MADE CONTACT WITH THE EYE. THERE WAS NO PATIENT INJURY AND NO OTHER INTERVENTION WAS REQUIRED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15900682 ↗