TECNIS SIMPLICITY DCB00 (REF DCB0000050)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474635784), received between Jan 26, 2021 and Nov 3, 2025 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2025Device Difficult to Setup or Prepare; Scratched Material; Device Difficult to Setup or Prepare; Scratched Material

  IT WAS REPORTED THAT ISSUES OCCURRED WHILE SLIDING THE PLUNGER TO LOAD THE PRELOADED INTRAOCULAR LENS (IOL). DESPITE APPLYING FORCE, THE LENS WAS SUCCESSFULLY LOADED AND EJECTED; HOWEVER, IT COULD NOT BE INSERTED AS IT BECAME SCRATCHED. THROUGH FOLLOW-UP, WE LEARNED THAT THE SURGEON FORCED THE LENS DURING HANDLING ON THE OVER-THE-COUNTER TABLE, WHICH CAUSED IT TO COME OUT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23459502 ↗
• MalfunctionJun 16, 2025Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), THE LENS APPEARED WRINKLED AND MARKED, LEADING TO ITS DISPOSAL. THROUGH FOLLOW-UP, WE LEARNED, THAT THE EVENT OCCURRED ON MAY 15TH, 2025 AND THE LENS RUPTURED DUE TO AN ERROR IN THE PRELOADING SYSTEM, THE PLUNGER PASSED OVER THE LENS. THE PATIENT WAS IMPLANTED WITH A REPLACEMENT DEVICE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22216417 ↗
• MalfunctionMar 7, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) COULD NOT UNFOLD. THERE WAS PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21554682 ↗
• MalfunctionJun 21, 2024Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS DEFECTIVE. THROUGH FOLLOW-UP, WE LEARNED THAT THE IOL GOT STUCK INSIDE THE INJECTOR AND THE HAPTIC WAS TORN. THE TIP OF THE CARTRIDGE WAS IN CONTACT WITH THE PATIENT'S EYE. NO ADDITIONAL MANEUVERS WERE PERFORMED. A REPLACEMENT IOL WAS IMPLANTED. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19581090 ↗
• MalfunctionSep 14, 2023Crack; Mechanical Jam; Ejection Problem; Crack; Mechanical Jam; Ejection Problem

  IT IS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) TRAILING HAPTIC STUCK IN THE INJECTOR DURING IMPLANTATION OR APPLICATION. SURGEON WAS ABLE TO FULLY INSERT AND USE THE LENS (IMPLANTED). NO PATIENT INJURY OR MEDICAL AND SURGICAL INTERVENTION IS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17746268 ↗
• MalfunctionJan 26, 2021Device Damaged by Another Device; Scratched Material; Device Damaged by Another Device; Scratched Material

  IT WAS REPORTED THAT A DCB00 PRE-LOADED DEVICE INJECTOR MALFUNCTION, SCRATCHED LENS. DURING HANDLING BUT PRIOR TO INSERTION. NO PATIENT CONTACT. NO ADVERSE EFFECT, INJURY OR SURGICAL INTERVENTION REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11231902 ↗