TECNIS SIMPLICITY DIB00 (REF DIB00U0105)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474731561), received between May 8, 2023 and Oct 10, 2024 — classified as 1 injury, 2 malfunctions.

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

• MalfunctionOct 10, 2024Break; Break

  IT WAS REPORTED THAT THE MONOFOCAL LENS WAS DAMAGED DURING HANDLING. THERE WAS NO CONTACT WITH THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20421319 ↗
• InjuryNov 22, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD TO EXPLANTED DUE TO AN IOL DEFECT. ANOTHER JOHNSON & JOHNSON EYHANCE LENS WAS IMPLANTED AS A REPLACEMENT. THE PATIENT IS EXPERIENCING K EDEMA AND IS GOING TO HAVE IT FOR WEEKS. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) /2023 REPORTING THIS WAS NOT A PLANNED EXPLANTATION. ON THE DAY OF THE SURGERY, THE SURGEON IMPLANTED A DEFECTIVE LENS WHICH THE SURGEON THEN HAD TO EXPLANT AND REPLACE WITH A NEW IOL. THE SERIAL NUMBER AND EVENT DATE WAS PROVIDED ON (B)(6) 2023. THE IOL IS NOT AVAILABLE FOR RETURN. ON (B)(6) 2023, IT WAS REPORTED A NON-CENTRAL CRACK WAS ON THE LENS. ALSO REPORTED AS SCRATCHED/DEFECTIVE LENS. THE SURGEON IMPLANTED THE LENS DEFECT IN THE PATIENT'S LEFT EYE AND IT WAS PERIPHERAL. THE PATIENT WAS ASYMPTOMATIC. THEN ON (B)(6) 2023, IT WAS REPORTED CRACK IN THE LENS. THE IOL WAS EXPLANTED AND A NEW LENS WAS INSERTED ON THE SAME DAY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Swelling/ Edema

  MAUDE report 18196951 ↗
• MalfunctionMay 8, 2023Device Difficult to Setup or Prepare; Scratched Material; Device Difficult to Setup or Prepare; Scratched Material

  DOCTOR REPORTED HE HAD PROBLEMS WITH TWO JOHNSON AND JOHNSON(JNJ) PRELOADED DEVICES THAT ARE 10.5 DIOPTER. ALL OTHER POWERS WERE FINE. THE FIRST INTRAOCULAR LENS (IOL) HAD SOME RESISTANCE DURING INJECTION. THE IOL CAME OUT WITH A LARGE CENTRAL DIVOT IN THE OPTIC. IT HAD TO BE CUT OUT AND REMOVED. THE SECOND IOL ALSO HAD RESISTANCE AND WOULD NOT RELEASE FROM THE INJECTOR. THE TIP OF THE CARTRIDGE TOUCHED THE EYE. THE IOL WAS STUCK, DOCTOR PULLED OUT THE INJECTOR AND USED A THIRD LENS TO COMPLETE THE PROCEDURE. THE THIRD IOL WAS FINE. DOCTOR STATED HE DOESN¿T REMEMBER EVER HAVING A PROBLEM LIKE THIS BUT SPOKE NOW TO OTHER DOCTORS WHO HAVE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16892682 ↗