TECNIS SIMPLICITY DCB00 (REF DCB0000100)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05050474635883), received between Apr 19, 2021 and Jul 29, 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.

• MalfunctionJul 29, 2026Crack; Mechanical Problem; Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50071502 ↗
• MalfunctionAug 26, 2025Break; Ejection Problem; Break; Ejection Problem

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS DEFECTIVE AND HAD AN UNFOLDING PROBLEM DURING A PROCEDURE. THE LENS WAS PARTIALLY INSERTED INTO THE PATIENT'S RIGHT EYE, THAT NECESSITATED AN INCISION ENLARGEMENT AND SUTURING. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THROUGH FOLLOW UP, IT WAS CONFIRMED THERE WAS LENS DAMAGE AND THE LENS WAS PARTIALLY INSERTED. AN INCISION ENLARGEMENT AND SUTURE WERE REQUIRED. ADDITIONAL INFORMATION WAS PROVIDED CLARIFYING THAT THE SUTURE WAS PROPHYLACTICALLY USED TO PREVENT A LEAK. THE IMPLANTATION OF THE REPLACEMENT LENS WAS DONE SUCCESSFULLY. NO OTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 22898296 ↗
• MalfunctionJun 12, 2025Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT THE HAPTIC OF A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS FOUND TO BE BROKEN DURING HANDLING. UPON FOLLOW-UP, IT WAS CONFIRMED THAT THERE WAS NO USER ERROR. THERE WAS NO PATIENT INVOLVEMENT IN THIS INCIDENT, AND THE DEVICE WAS NOT IN CONTACT WITH THE PATIENT'S EYE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22191759 ↗
• MalfunctionMay 20, 2025Crack; Mechanical Jam; Crack; Mechanical Jam

  IT WAS REPORTED THAT AFTER INTRODUCING THE INSERTER INTO THE PATIENT'S EYE, THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) CARTRIDGE TIP BENT AND THE IOL WAS STUCK INSIDE. CUSTOMER WAS UNABLE TO IMPLANT THE LENS. THE DEVICE WAS WITHDRAWN FROM THE EYE AND A BACK UP DEVICE WAS USED WITHOUT FURTHER ISSUE. THERE WAS NO PATIENT INJURY REPORTED. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22057716 ↗
• MalfunctionMay 12, 2025Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS TORN AFTER INSERTION. THE LENS WAS REMOVED AND REPLACED WITH THE SAME MODEL AND DIOPTER DURING THE SAME PROCEDURE. THERE WERE NO INJURIES, AND NO ADDITIONAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22006585 ↗
• MalfunctionSep 26, 2024Break; Break

  IT WAS REPORTED THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), SERIAL (B)(6), BECAME FAULTY DURING SURGERY. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20314823 ↗
• MalfunctionApr 6, 2023Break; Break

  IT WAS REPORTED, "DEFECTIVE WASTED LENS" ON A PRELOADED SUSPECT PRODUCT. UNKNOWN IF THERE WAS PATIENT CONTACT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16696864 ↗
• MalfunctionAug 12, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT AT THE END OF THE OPERATION, AFTER IMPLANTING A DCB INTRAOCULAR LENS (IOL), THE OPERATOR DETECTED TWO BLACK "THREADS" IN THE PATIENT'S EYE AND USED EXTRA SUCTION TO REMOVE THEM. THE CUSTOMER DOES NOT KNOW IF THE THREADS WERE INTRODUCED INTO THE EYE WITH THE LENS. THE LENS WAS FULLY INSERTED AND REMAINS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12317070 ↗
• MalfunctionApr 19, 2021Scratched Material; Scratched Material

  IT WAS REPORTED THAT A DCB00 INTRAOCULAR LENS (IOL) HAD SCRATCHES OBSERVED AFTER IMPLANTED. THE LENS WAS CUT OUT IN PIECES AND THROWN AWAY. THERE WAS NO INJURY. NO ADVERSE EFFECT, INJURY OR SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT IS DOING FINE. NO DETAILS ON REPLACEMENT LENS. NO FURTHER INFORMATION IS AVAILABLE, NO FOLLOW-UP IS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11685112 ↗