TECNIS SIMPLICITY DIB00 (REF DIB00U0165)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 05050474731684), received between May 24, 2022 and Nov 11, 2025 — classified as 4 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2025Break; Break

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL DIB00, WAS OPENED, NOT USED, AND NOTED TO BE CRACKED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23524470 ↗
• MalfunctionAug 29, 2025Ejection Problem; Ejection Problem

  THE DIB00 MODEL INTRAOCULAR LENS (IOL) WAS COMPLETELY IN THE PATIENT'S EYE HOWEVER, THE DEVICE DID NOT WORK AS INTENDED. THE INJECTOR WAS STUCK TO THE LENS AND WOULD NOT LET GO OF THE IOL. THE SURGEON HAS TO USE A SECOND INSTRUMENT TO DETACH THE INJECTOR FROM THE IOL. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED USING ANOTHER IOL. PATIENT PROGNOSIS POST-PROCEDURE IS ALSO UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22929466 ↗
• MalfunctionMay 19, 2025Break; Break

  IT WAS REPORTED THAT AFTER THE IMPLANTATION OF THE PRELOADED INTRAOCULAR LENS (IOL) INTO THE PATIENT'S RIGHT EYE AS THE SURGEON NOTICED A CRACK IN THE CENTER OF THE OPTIC OF THE LENS UNDER THE MICROSCOPE. THE LENS WAS REMOVED AS THE CRACK COULD CAUSE VISUAL DISTURBANCES. THE LENS WAS REMOVED AND REPLACED WITH SAME MODEL AND DIOPTER LENS IN THE SAME PROCEDURE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22048666 ↗
• MalfunctionMar 10, 2025Device Difficult to Setup or Prepare; Scratched Material; Device Difficult to Setup or Prepare; Scratched Material

  THE PLUNGER WAS DIFFICULT TO TURN WHILE ADVANCING THE DIB00 MODEL INTRAOCULAR LENS (IOL) ON THE MAYO STAND. AFTER THE IOL WAS INSERTED IN THE PATIENT'S EYE, A MARK WAS OBSERVED ON THE IOL. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT REMAINS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21565484 ↗
• InjuryFeb 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS INSERTED AND THEN REMOVED WITHIN THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A NON-JOHNSON AND JOHNSON IOL. THE INCISION WAS ENLARGED BUT NO VITRECTOMY WAS REQUIRED. THE PATIENT WAS NOT HARMED AS A RESULT OF THIS EVENT. THE EVENT IS NOT RELATED TO A MISCALCULATION ISSUE, IMPROPER FIT, OR MANUFACTURER DEFECT. THE CUSTOMER USED OPHTHALMIC VISCOSURGICAL DEVICE (OVD) AND BALANCED SALT SOLUTION (BSS). THEY ALLOWED BOTH THE OVD AND BSS TO ACCLIMATIZE TO THE ROOM TEMPERATURE AND THERE WERE NO DELAYS IN THE SURGERY AFTER THE INSERTER WAS PREPPED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear

  MAUDE report 21465516 ↗
• MalfunctionFeb 7, 2025Break; Break

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) EDGE APPEAR TO BE WAS FRAYED. THE IOL WAS FULLY INSERTED AND REMAINS IMPLANTED. THE PRODUCT IS NOT AVAILABLE FOR RETURN. THROUGH FOLLOW UP IT WAS LEARNED THAT THERE WAS NO PATIENT INJURY AND NO MEDICAL OR SURGICAL INTERVENTION PERFORMED. THE PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21337669 ↗
• InjuryDec 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON HAD TO COMPLETE AN EMERGENCY ANTERIOR VITRECTOMY AFTER THE PRELOADED INTRAOCULAR LENS (IOL) WAS PLACED. THE LENS WAS REMOVED AND REPLACED WITH A NEW LENS IN THE SAME PROCEDURE. FROM ADDITIONAL INFORMATION IT WAS UNKNOWN WHY EMERGENCY VITRECTOMY WAS PERFORMED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20886281 ↗
• MalfunctionAug 28, 2024Break; Ejection Problem; Break; Ejection Problem

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS BECAME STUCK IN THE MAIN WOUND. THE LENS WAS SUBSEQUENTLY REMOVED, REVEALING DAMAGE TO THE TRAILING HAPTIC. A NEW LENS, THE DIBOO +16.5 D LENS, WAS RETRIEVED AND INJECTED INTO THE CAPSULAR BAG. THE INSERTION PROCESS WAS SUCCESSFULLY COMPLETED USING A CONNOR HANDPIECE, AND NO COMPLICATIONS WERE ENCOUNTERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20089591 ↗
• MalfunctionMay 17, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS IMPLANTED AND REMOVED DURING THE SAME PROCEDURE BECAUSE THE LENS HAD A SCRATCH IN IT. THE LENS WAS NOT STUCK IN THE CARTRIDGE. THE ISSUE WAS OBSERVED AFTER INSERTION OF THE LENS INTO THE EYE. THERE WAS NO PATIENT INJURY. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. THERE WERE NO ISSUES WITH THE PATIENT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19347673 ↗
• MalfunctionJan 17, 2024Break; Break

  IT WAS REPORTED THE DIB00 MODEL INTRAOCULAR LENS (IOL) WAS DEFECTIVE AND THE BACK-UP IOL WAS USED TO COMPLETE THE PROCEDURE. EXTENT OF PATIENT CONTACT AND PATIENT STATUS POST-PROCEDURE ARE UNKNOWN. SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18531072 ↗
• InjuryJan 3, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAD A LARGE GOUGE NEAR THE CENTER OF THE OPTIC AND THE DOCTOR HAD TO DO AN IOL EXCHANGE WHICH RESULTED IN A HYPHEMA AND LIKELY ENDOTHELIAL DAMAGE. THE CUSTOMER HAD ALREADY DISPOSED OF BOTH, THE LENS AND THE INJECTOR. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Corneal Endothelial Cell Loss; Hyphema

  MAUDE report 18441446 ↗
• MalfunctionNov 29, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THAT A PRELOADED INTRAOCULAR LENS (IOL) WAS DEFECTIVE. THIS WAS DESCRIBED AS SCRATCHES ON IOL PRIOR TO USE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18234975 ↗
• MalfunctionOct 31, 2023Break; Break

  IT WAS REPORTED THE PRE-LOADED DIB00 MODEL INTRAOCULAR LENS (IOL) WAS DAMAGED; EXTENT OF PATIENT CONTACT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18044671 ↗
• MalfunctionOct 4, 2023Contamination; Contamination

  IT WAS REPORTED THAT A BLACK FIBER WAS ATTACHED ON A PRE-LOADED INTRAOCULAR LENS (IOL) WHEN ADMINISTERING AN IMPLANT IN THE PATIENT'S RIGHT EYE. IT WAS LEARNED THAT THERE WAS PATIENT CONTACT WITH THE IOL. THE BLACK FIBER WAS REMOVED USING A CAPSULE FORCEPS. NO ADDITIONAL PROCEDURES PERFORMED. NO EVIDENCE OF SURGICAL COMPLICATIONS OR UNUSUAL SEQUELAE. THE SUSPECT IOL REMAINS IMPLANTED, THE BLACK FIBER WAS REMOVED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17871566 ↗
• MalfunctionJun 19, 2023Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WASTED. THE LENS WAS DAMAGED/NEVER WAS IMPLANTED. THERE WAS NO PATIENT CONTACT. NO USE ERROR REPORTED. THE LENS IS NOT RETURNING, DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17159981 ↗
• MalfunctionMay 16, 2023Break; Break

  IT WAS REPORTED THE JOHNSON AND JOHNSON(JNJ) PRELOADED INTRAOCULAR LENS (IOL) WAS MARKED WITH MULTIPLE IMPERFECTIONS AFTER INSERTION. THE IOL WAS REMOVED AND REPLACED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16939596 ↗
• InjuryApr 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) WAS PLACED IN, THE CAPSULE TORE WHICH REQUIRED A 3-PIECE LENS. THE LENS WAS FULLY INSERTED, REMOVED, AND REPLACED IN THE SAME PROCEDURE. A NON-JOHNSON AND JOHNSON LENS WAS USED AS THE REPLACEMENT IOL. THERE WERE NO MEDICAL OR SURGICAL INTERVENTIONS REQUIRED. THE PATIENT OUTCOME WAS NOT PROVIDED. THE EXPLANTED LENS WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 16812179 ↗
• MalfunctionFeb 17, 2023Crack; Crack

  IT WAS REPORTED THAT DURING INSERTION OF AN INTRAOCULAR LENS (IOL) THE CARTRIDGE BROKE/CRACKED. THE CARTRIDGE TIP CONTACTED THE PATIENT'S OPERATIVE EYE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16401419 ↗
• MalfunctionAug 18, 2022Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) CRACKED WHEN TRYING TO LOAD IT. REPORTEDLY, THE LOADING ISSUE OCCURRED DURING THE HANDLING OF THE PRODUCT. THERE WAS NO PATIENT CONTACT WITH THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15255732 ↗
• MalfunctionMay 24, 2022Break; Break

  IT WAS REPORTED THAT A PRELOADED INTRAOCULAR LENS (IOL) HAD HAPTIC BENT/BROKE. THE SURGEON STATED THAT THE HAPTICS WERE MESSED UP. NO PATIENT CONTACT. SUSPECT LENS/PRELOADED PRODUCT WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14482680 ↗