TECNIS SIMPLICITY DIB00 (REF DIB00U0110)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05050474731578), received between Mar 17, 2023 and Mar 31, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Break

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS DEFECTIVE. THE EXTENT OF PATIENT CONTACT IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24743233 ↗
• MalfunctionFeb 19, 2026Break

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS FOUND TO BE CRACKED ACROSS THE OPTIC DURING IMPLANTATION. THE LENS WAS FULLY INSERTED INTO THE RIGHT EYE AND SUBSEQUENTLY REMOVED DURING THE SAME PROCEDURE. A REPLACEMENT LENS FROM JOHNSON & JOHNSON WITH THE SAME MODEL AND DIOPTER (DIB00, 11.0 D) WAS USED. NO VITRECTOMY, SUTURES, OR MEDICATIONS OUTSIDE OF STANDARD CARE WERE REQUIRED. THERE WAS NO DELAY IN THE PROCEDURE, ALTHOUGH IT WAS UNKNOWN WHETHER UNPLANNED INCISION ENLARGEMENT OCCURRED. THERE WERE NO ACTIVITIES THAT THE PATIENT WAS UNABLE TO PERFORM PRIOR TO SURGERY. THE PATIENT HAS FULLY RECOVERED. THE DIRECTIONS FOR USE WERE FOLLOWED. THROUGH FOLLOW-UP, THE SURGEON CONFIRMED THAT THE LENS WAS INSERTED AS IT NORMALLY WOULD BE AND BELIEVED THAT THE CRACK MAY HAVE BEEN PRESENT BEFORE DELIVERY. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24394454 ↗
• MalfunctionJan 16, 2026Break

  IT WAS REPORTED THAT THE SURGEON NOTED A CUT ON THE LEADING HAPTIC OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) DURING THE IMPLANTATION OR APPLICATION PROCESS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24102607 ↗
• MalfunctionJun 20, 2025Crack; Crack

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), THE INSERTER TUBE SPLIT OPEN DUE TO A THIN SPOT IDENTIFIED. THE TIP OF THE CARTRIDGE WAS IN CONTACT WITH THE PATIENT'S EYE. THROUGH FOLLOW UP, IT WAS LEARNED THAT THE PATIENT HAD A STANDARD CATARACT SURGERY. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION OUTSIDE OF THE STANDARD CARE REQUIRED. THE SURGEON REPORTED THE LENS NEVER ENTERED THE PATIENT¿S EYE. THE SURGEON BELIEVES THE NURSES MAY HAVE KEPT THE PRODUCT BUT WAS NOT SURE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22303065 ↗
• MalfunctionOct 6, 2023Break; Break

  IT WAS REPORTED THAT THE MONOFOCAL INTRAOCULAR LENS (IOL) WAS DEFECTIVE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17884143 ↗
• MalfunctionJun 8, 2023Crack; Crack

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) CARTRIDGE TIP WAS PLACED INTO THE RIGHT EYE BUT THE LENS WAS NOT IMPLANTED BECAUSE THE CARTRIDGE TIP WAS BENT. THERE WAS NO DAMAGE TO THE HAPTIC OR OPTIC OF THE IOL. PER THE SURGEON'S DOCUMENTATION, THE MAIN WOUND WAS "SLIGHTLY DAMAGED" BUT SUTURING WAS NOT NEEDED. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. PER THE SURGEON¿S NOTE, THE REPLACEMENT LENS (SAME MODEL AND DIOPTER) WAS PLACED WITHOUT ANY ISSUES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 17087822 ↗
• MalfunctionMar 17, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THE PRE-LOADED DIB00 INTRAOCULAR LENS (IOL) UNROLLED AND WAS REMOVED AND REPLACED FOR BETTER INSERTION. THERE WAS NO INCISION ENLARGEMENT, NO SUTURE(S), AND NO VITRECTOMY. REPLACEMENT LENS INFORMATION AND PATIENT OUTCOME POST-PROCEDURE ARE BOTH UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16566525 ↗