TECNIS SIMPLICITY DIB00 (REF DIB00U0260)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474731882), received between Jul 10, 2024 and Jan 9, 2026 — classified as 1 injury, 2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL DIB00, WAS IMPLANTED IN THE PATIENT¿S LEFT EYE. POSTOPERATIVELY, THE PATIENT WAS MORE MYOPIC THAN ANTICIPATED. A SECONDARY PROCEDURE WAS PERFORMED TO EXPLANT THE ORIGINAL LENS AND REPLACE IT WITH THE SAME MODEL OF LOWER DIOPTER (+23.5D). THE PROCEDURE DID NOT REQUIRE INCISION ENLARGEMENT, UNPLANNED VITRECTOMY, OR SUTURES. THE PATIENT REQUIRED NO ADDITIONAL MEDICAL ATTENTION OR MEDICATIONS BEYOND STANDARD CARE. THE PATIENT OUT COME WAS NOT PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT HAD BILATERAL LENS IMPLANTATION. THIS REPORT IS FOR THE PATIENT'S LEFT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE RIGHT EYE.

  Patient problems: Visual Impairment

  MAUDE report 24029339 ↗
• MalfunctionAug 22, 2024Break; Break

  IT WAS REPORTED THE PRE-LOADED DIB00 MODEL INTRAOCULAR LENS (IOL) USED DURING 31-JUL-2024 SURGERY WAS DEFECTIVE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20037402 ↗
• MalfunctionJul 10, 2024Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS CURLED AT THE END. THE CARTRIDGE TIP ONLY HAD PATIENT CONTACT. BACK UP LENS WAS USED TO COMPLETE THE PROCEDURE. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT THE LENS CURLED UP AND SPLIT THROUGH THE TIP OF THE CARTRIDGE. THE ISSUE WAS NOTICED DURING THE IMPLANTATION/APPLICATION. THE PROCEDURE WAS COMPLETED WITH SAME MODEL LENS WITH SAME DIOPTER. THERE WAS NO PATIENT INJURY. BALANCED SALT SOLUTION (BSS) WAS USED AS A CARTRIDGE LUBRICANT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19712233 ↗