TECNIS SIMPLICITY DCB00 (REF DCB0000080)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474635845), received between Apr 24, 2022 and Nov 24, 2025 — classified as 4 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.

• MalfunctionNov 24, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO THE PATIENT¿S EYE. THE IOL WAS REMOVED BECAUSE THE BACK HAPTIC RIPPED OFF AND WAS DAMAGED. THE IOL WAS REMOVED AND REPLACED WITH A BACKUP OF THE SAME MODEL AND DIOPTER. THE INCISION WAS ENLARGED. THERE WAS NO PATIENT INJURY. THE PATIENT WAS REPORTED AS DOING ¿FINE¿. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 23633240 ↗
• MalfunctionSep 16, 2025Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THAT DURING THE PRIMING PHASE OF A PROCEDURE INVOLVING AN PRELOADED INTRAOCULAR LENS, THE PLUNGER OF THE DEVICE MOVED OVER THE TOP OF THE INTRAOCULAR LENS, POTENTIALLY CAUSING DAMAGE TO THE HAPTICS, AS THE LENS DID NOT ADVANCE AS INTENDED DUE TO THE PLUNGER MISSING IT. THE PLUNGER WAS ALSO OBSERVED TO BE SLIGHTLY BENT. THERE WAS NO PATIENT CONTACT ASSOCIATED WITH THIS EVENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23069907 ↗
• MalfunctionJun 2, 2025Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) CAME OUT OF THE INSERTER BEFORE THE LENS WAS ALL THE WAY INTO THE EYE. THE SURGEON ASKED FOR THE BACK UP LENS TO COMPLETE THE PROCEDURE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22127243 ↗
• MalfunctionApr 24, 2022Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THAT DURING THE IMPLANTATION, THE PLUNGER PASSED IN FRONT OF THE OPTICS, NOT ALLOWING THE LENS TO BE ADVANCED OUT. WHEN THE LENS CAME OUT OF THE CARTRIDGE, THE OPTICS APPEARED DAMAGED. THERE WERE NO CLINICAL CONSEQUENCES, ANOTHER LENS WAS USED INSTEAD. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14191168 ↗