TECNIS SIMPLICITY DCB00 (REF DCB0000145)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474635975), received between Sep 10, 2021 and Jun 19, 2026 — classified as 4 malfunctions.

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

• MalfunctionJun 19, 2026Scratched Material

  IT WAS REPORTED THAT FOLLOWING IMPLANTATION, A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS OBSERVED TO HAVE A SCRATCH. THE IOL WAS SUBSEQUENTLY REMOVED AND DISCARDED, AND A REPLACEMENT LENS OF THE SAME DIOPTER WAS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25563507 ↗
• MalfunctionFeb 6, 2026Material Fragmentation

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS FOUND TO HAVE NO ATTACHMENTS TO HELP ANCHOR IT. THE LENS WAS FULLY INSERTED INTO THE PATIENT¿S LEFT EYE, BUT DUE TO THIS ISSUE, IT WAS REMOVED DURING THE SAME PROCEDURE. THE EVENT RESULTED IN A FIVE-MINUTE DELAY IN THE PROCEDURE. THERE WERE NO ACTIVITIES THAT THE PATIENT COULD NOT PERFORM PRIOR TO THE SURGERY. THE PATIENT¿S STATUS FOLLOWING THE EVENT HAS FULLY RECOVERED, AND NO UNPLANNED INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY OCCURRED. THE DIRECTIONS FOR USE WERE FOLLOWED, AND NO ADDITIONAL MEDICAL ATTENTION OR MEDICATION OUTSIDE OF STANDARD CARE WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24281132 ↗
• MalfunctionNov 27, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAD DAMAGED HAPTICS. THERE WAS NO PATIENT INJURY REPORTED. THE PROCEDURE WAS COMPLETED WITH A BACK UP IOL. THROUGH FOLLOW UP, WE LEARNED THAT ONE HAPTIC WAS BROKEN OFF AND THIS WAS NOTED BY THE SURGEON PRIOR TO ANY PATIENT CONTACT. THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20799852 ↗
• MalfunctionSep 10, 2021Break; Break

  IT WAS REPORTED AN INTRAOCULAR LENS (IOL) WAS IMPLANTED AND REMOVED BY THE DOCTOR DUE TO A CRACK IN THE HAPTIC; IOL WAS REPLACED WITH A BACK-UP LENS WITH THE SAME MODEL AND DIOPTER SIZE. THERE WAS NO HARM TO THE PATIENT. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING NO UNPLANNED INCISION ENLARGEMENT AND NO SUTURE(S) REQUIRED. PATIENT OUTCOME POST-PROCEDURE WAS REPORTED AS SUCCESSFUL, WITH NO COMPLICATIONS, AND IT TOOK A LITTLE BIT LONGER THAN SCHEDULED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12451842 ↗