TECNIS SIMPLICITY DIB00 (REF DIB00U0080)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474731516), received between Oct 19, 2021 and Aug 8, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2022Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) FAILED TO ENGAGE. THE SURGEON NOTICED SOMETHING THAT DIDN'T LOOK RIGHT BEFORE PRIMING LENS. FURTHER INFORMATION RECEIVED CLARIFIED THAT THE HAPTIC LOOKED BENT AND THE LENS WAS STUCK IN THE CARTRIDGE. THERE WAS NO PATIENT CONTACT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15189091 ↗
• MalfunctionOct 19, 2021Crack; Mechanical Jam; Crack; Mechanical Jam

  IT WAS REPORTED THAT WHEN ATTEMPTED TO IMPLANT A TECNIS SIMPLICITY INTRAOCULAR LENS(IOL), MODEL DIB00, THE LENS DID NOT DISPENSE POTENTIALLY DUE TO A FAULTY TIP ON THE INSERTER. ACCOUNT PROVIDED THAT THE TIP WAS SQUEEZED TOGETHER, NOTHING WOULD BE ABLE TO COME THROUGH IT. THE INSERTER MADE CONTACT WITH THE EYE, BUT THE LENS DID NOT SINCE IT DID NOT DISPENSE FROM THE INSERTER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACKUP LENS OF THE SAME MODEL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12662226 ↗