TECNIS SIMPLICITY DCB00 (REF DCB0000340)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474636361), received between Feb 13, 2023 and Mar 28, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 28, 2025Break; Break

  IT WAS REPORTED THAT PRELOADED INTRAOCULAR LENS (IOL) CRACKED UPON INSERTION AND THIS LENS HAS BEEN PROPERLY DISPOSED OF. FURTHERMORE, IT WAS REVEALED THAT THERE WAS NO CONTACT WITH THE PATIENT, AS THE LENS CRACKED UPON OPENING THE PACKAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER J&J LENS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21724626 ↗
• MalfunctionFeb 25, 2025Break; Break

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS FAULTY. THE LENS WAS NOT IN CONTACT WITH THE EYE; ONLY THE CARTRIDGE TIP MADE CONTACT WITH THE EYE. NO ADDITIONAL INTERVENTIONS WERE REQUIRED AND THERE WERE NO REPORTS OF INJURY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21462085 ↗
• MalfunctionAug 25, 2024Use of Device Problem; Expiration Date Error; Use of Device Problem; Expiration Date Error

  IT WAS REPORTED THE PRE-LOADED DCB00 MODEL INTRAOCULAR LENS (IOL) THAT WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE WAS EXPIRED. DATE OF SURGERY WAS (B)(6) 2023 AND PRODUCT EXPIRATION DATE WAS 07-APR-2023. THERE WERE NO VISUAL ISSUES REPORTED BY THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20061037 ↗
• MalfunctionApr 21, 2023Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) ON A PRELOADED PRODUCT WAS DEFECTIVE. UNKNOWN ON WHAT EXACTLY WAS WRONG WITH THE IOL. ALSO, UNKNOWN IF THERE WAS PATIENT CONTACT OR NOT. PER FAXED DOCUMENT THE IOL WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16791771 ↗
• MalfunctionFeb 13, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE HAPTIC OF THE PRELOADED INTRAOCULAR LENS (IOL) CAME OFF AS THE LENS WAS BEING IMPLANTED INTO PATIENT'S OPERATIVE EYE. THE LENS WAS PARTIALLY INSERTED INTO THE EYE, HOWEVER, WAS REMOVED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16368819 ↗