TECNIS SIMPLICITY DCB00 (REF DCB0000120)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05050474635920), received between Apr 7, 2021 and Jan 2, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2026Break

  IT WAS REPORTED THAT AFTER FULLY INSERTING THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) INTO THE PATIENT¿S RIGHT EYE, A CRACK WAS NOTICED IN THE IOL. THE LENS WAS SUBSEQUENTLY REMOVED AND REPLACED WITH A BACKUP LENS OF THE SAME MODEL AND DIOPTER DURING THE SAME PROCEDURE. THE CAUSE OF THE CRACK WAS UNKNOWN. IT IS UNKNOWN IF FORCE WAS USED TO DELIVER THE LENS. DAILY ACTIVITIES WERE NOT SIGNIFICANTLY AFFECTED, AND NO ADDITIONAL INTERVENTIONS SUCH AS INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY WERE REQUIRED. NO ADDITIONAL MEDICAL ATTENTION WAS REQUIRED. THERE WAS NO DELAY IN THE PROCEDURE AND THE DIRECTIONS FOR USE WERE FOLLOWED. IT WAS NOTED THAT THE HAPTIC OR OPTIC WAS NOT DAMAGED BEFORE INSERTION. THE PATIENT HAS FULLY RECOVERED. IT WAS UNKNOWN WHETHER THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23950929 ↗
• MalfunctionMay 5, 2025Crack; Crack

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) THAT THE TIP OF THE INSERTER SPLIT AS THE SURGEON PUT THE LENS IN THE PATIENT'S OPERATIVE EYE. THE LENS WENT IN FINE AND THERE WERE NO ISSUES. THE PATIENT HAS FULLY RECOVERED. ONLY THE INSERTER IS AVAILABLE FOR EVALUATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21964806 ↗
• MalfunctionOct 26, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT THE HAPTICS OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) OPENED SLOWLY. THROUGH FOLLOW UPS WE LEARNED THE HAPTICS WERE UNFOLDED WITH THE IRRIGATION ASPIRATION (IA) HANDPIECES. THE LENS REMAINS IMPLANTED. THE CUSTOMER SUSPECTED THAT THE TEMPERATURE DURING IMPLANTATION OF THE LENS MIGHT BE RESPONSIBLE FOR THE SLOW UNFOLDING. INFORMATION REGARDING THE RECOMMENDED TEMPERATURES HAS BEEN PROVIDED TO THE CUSTOMER. NO FURTHER DETAILS WERE PROVIDED. TWO SEPARATE REPORTS WILL BE SUBMITTED FOR THE OTHER TWO LENSES CAPTURED IN THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20540208 ↗
• MalfunctionOct 4, 2024Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT DURING HANDLING PRIOR TO INSERTION, A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS DAMAGED AND STUCK IN CARTRIDGE AND WOULD NOT ADVANCE. THERE WAS NO PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20372104 ↗
• MalfunctionJun 9, 2023Break; Break

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON(JNJ) INTRAOCULAR LENS (IOL) HAS A BAD HAPTIC. THE ISSUE WAS NOTICED UPON OPENING THE PACKAGE. THERE WAS NO PATIENT CONTACT. CUSTOMER CLARIFIED THAT THE INNER POUCH WAS NOT OPENED OR UNSEALED WHEN IT WAS RECEIVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17099113 ↗
• MalfunctionApr 11, 2023Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) LOADED IN THE INSERTER AND WAS STUCK IN CARTRIDGE. THE HAPTIC KINKED AND CANNOT BE DEPLOYED/IMPLANTED. THERE WAS NO PATIENT CONTACT WITH THE PRODUCT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16716009 ↗
• MalfunctionJan 6, 2023Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem; Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE INNER BOX RECEIVED DAMAGED, AND THE SEAL OF THE INTRAOCULAR LENS (IOL) BOX WAS BROKEN. THE ISSUE WAS NOTICED UPON OPENING THE PACKAGE AND THERE WAS NO PATIENT CONTACT WITH THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16110717 ↗
• MalfunctionDec 14, 2022Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) CAME OUT BROKEN IN HALF. THROUGH FOLLOW-UP WE LEARNED THAT THE LENS WAS ALREADY DEFECTIVE WHEN IT CAME OUT OF THE BOX. THERE WAS NO PATIENT CONTACT WITH THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15981441 ↗
• MalfunctionApr 7, 2021Crack; Crack

  IT WAS REPORTED THAT THE CARTRIDGE TIP OF THE PRELOADED DEVICE WAS CRACKED DURING THE INSERTION OF THE LENS INTO THE EYE. THE LENS WAS FULLY IMPLANTED AND THE EVENT WAS OBSERVED AFTER THE IMPLANTATION. THE OUTCOME DOES NOT SIGNIFICANTLY INTERFERES WITH ACTIVITIES OF DAILY LIFE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11625855 ↗