TECNIS SIMPLICITY DIB00 (REF DIB00U0255)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05050474731875), received between Jan 26, 2022 and Oct 15, 2025 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE DUE TO A MYOPIC SURPRISE. THE PATIENT WAS NOT SATISFIED WITH THE DISTANCE VISION. THE SURGEON TARGETED -2.50. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 23297153 ↗
• MalfunctionJun 9, 2025Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WOULD NOT ADVANCE INTO THE PATIENT'S EYE. THERE WAS INCISION ENLARGED BUT NO SUTURES NEEDED. NO OTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 22169583 ↗
• MalfunctionMay 17, 2025Break; Break

  IT WAS REPORTED THAT THE HAPTICS OF THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WERE STUCK TOGETHER INSIDE THE EYE. THE DOCTOR HAD TO MANUALLY SEPARATE THEM. THERE WERE NO FURTHER COMPLICATIONS AND HE WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22040971 ↗
• InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PRE-LOADED DIB00 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). DUE TO COMPLAINTS OF ANISOMETROPIA (UNEXPECTED POSTOP REFRACTION) AND THE PATIENT'S INABILITY TO DRIVE, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A DIU150 22.5 DIOPTER IOL. THERE WAS NO INCISION ENLARGEMENT AND NO VITRECTOMY DURING THE LENS EXCHANGE PROCEDURE. THERE WAS NO MEDICATION PRESCRIBED (OUTSIDE OF STANDARD CARE) AND NO MEDICAL ATTENTION WAS REQUIRED. THE IOL DIRECTIONS FOR USE WERE FOLLOWED. PATIENT PROGNOSIS POST-LENS EXCHANGE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 20178610 ↗
• InjuryMar 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE LEFT EYE. REPORTEDLY, THE PATIENT¿S BLURRY VISION MAY HAVE BEEN A MISCALCULATION BECAUSE THE DOCTOR HAD TO CHANGE BY TWO DIOPTERS. DOCTOR IS NOT CERTAIN, BUT IT SEEMED THE IOL WAS NOT POSITIONED CORRECTLY, NOT SITTING RIGHT IN THE EYE. CUSTOMER SAID IT COULD HAVE BEEN THE PATIENT¿S ANATOMY. THE DOCTOR IS NOT SAYING THE DIOPTER IS WRONG, BUT HE¿D LIKE JNJ TO CONFIRM IT. THE IOL WAS REPLACED WITH ANOTHER JNJ MODEL AR40E 23.0 DIOPTER. THE PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 18843270 ↗
• MalfunctionJan 17, 2024Break; Break

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAD BEEN DAMAGED WHEN IMPLANTED. THE LENS WAS DISCARDED. THERE IS NO INFORMATION ABOUT THE REPLACEMENT IOL. THE PRODUCT IS NOT AVAILABLE FOR RETUNE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18531804 ↗
• MalfunctionJan 26, 2022Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THE TECNIS EYHANCE PRELOADED INTRAOCULAR LENS (IOL) HAD A DEFECT IN THE OPTIC AND THE PLUNGER OVERRODE THE OPTIC DURING SURGERY. THE SURGEON HAD TO CUT AND REMOVE THE LENS. THE LENS WAS DISCARDED. THERE IS NO INJURY TO THE PATIENT. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THE PATIENT'S POST-OPERATIVE OUTCOME WAS NOT AVAILABLE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13362375 ↗