TECNIS SIMPLICITY DCB00 (REF DCB0000105)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474635890), received between Feb 9, 2022 and Mar 18, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Crack” (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.

• MalfunctionMar 18, 2023Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS HAPTIC WAS DANGLED AND CRACKED WHEN THE DOCTOR ATTEMPTED TO FULLY INSERT IT IN THE PATIENTS LEFT EYE. THE ISSUE WAS OBSERVED AFTER INSERTION AND IT WAS REMOVED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16570058 ↗
• MalfunctionAug 1, 2022Crack; Material Split, Cut or Torn; Crack; Material Split, Cut or Torn

  IT WAS REPORTED THAT A PRELOADED INTRAOCULAR LENS (IOL) CARTRIDGE CRACKED AND THE IOL WAS DEFECTIVE AS IT WAS SPLIT. THERE WAS PATIENT CONTACT WITH THE PRODUCT; HOWEVER, NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15143124 ↗
• InjuryJul 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO DECREASED VISUAL ACUITY. THE REPLACEMENT LENS WAS A DIFFERENT MODEL IOL WITH 0.5 DIOPTER POWER DIFFERENCE. NO FURTHER MEDICAL OR SURGICAL INTERVENTION WAS REPORTED. PATIENT WAS NORMAL WHEN DISCHARGED. VISUAL ACUITY READINGS OBSERVED AS 20/70- PRE-INITIAL IMPLANT, 20/30 POST-INITIAL IMPLANT, 20/40-2 POST-REPLACEMENT IOL. THE EXPLANTED IOL IS NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort

  MAUDE report 15047757 ↗
• MalfunctionFeb 9, 2022Crack; Crack

  IT WAS REPORTED THAT TIP OF THE PRELOADED DEVICE CRACKED SIDEWAYS, ALTHOUGH THE SURGEON WAS ABLE TO GET THE LENS INSERTED BEFORE THE CARTRIDGE CRACKED. THE DEVICE IS NOT AVAILABLE FOR RETURN, AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13502264 ↗