TECNIS SIMPLICITY DIB00 (REF DIB00U0200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 05050474731752), received between Nov 19, 2021 and Apr 17, 2026 — classified as 17 injuries, 53 malfunctions.

The most frequently reported specific device problem is “Break” (19 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 70 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026Crack

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) CARTRIDGE TIP CRACKED DURING IOL INSERTION. THE LENS WAS INJECTED INTO THE PATIENT'S EYE WITH NO DEFECTS OR ISSUES. THERE WAS NO PATIENT HARM. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24916060 ↗
• MalfunctionMar 30, 2026Crack

  IT WAS REPORTED THAT DURING IMPLANTATION OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL DIB00, THE TIP OF THE INSERTER CRACKED AS THE LENS WAS BEING DELIVERED. A REPLACEMENT LENS OF THE SAME MODEL AND DIOPTER WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24710318 ↗
• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) DID NOT COME OUT PROPERLY AND WAS WASTED. THE ISSUE OCCURRED DURING THE HANDLING OF THE DEVICE BUT PRIOR TO INSERTION INTO THE EYE. HOWEVER, IT IS UNKNOWN IF THERE WAS ANY PATIENT CONTACT. FOLLOW-UP WAS PERFORMED BUT NO FURTHER INFORMATION HAS BEEN PROVIDED. THEREFORE, THIS EVENT IS CONSERVATIVELY ASSESSED AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24709195 ↗
• MalfunctionMar 12, 2026Crack

  IT WAS REPORTED THAT THE TIP OF THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS CRACKED. THE ISSUE OCCURRED DURING ADVANCEMENT OF THE LENS THROUGH THE TIP OF THE INJECTOR. THE CUSTOMER CONFIRMED THAT THE SIDE AND TIP OF THE CARTRIDGE CRACKED WHEN THE PLUNGER WENT THROUGH. THE CARTRIDGE HAD CONTACT WITH THE LEFT EYE WHICH IS THE OPERATIVE EYE. A BACKUP IOL OF THE SAME MODEL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO MEDICAL INTERVENTION REQUIRED AND NO COMPLICATIONS SUCH AS A CAPSULE TEAR, VITRECTOMY, INCISION ENLARGEMENT OR SUTURES. THE PATIENT IS DOING WELL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24586948 ↗
• MalfunctionDec 10, 2025Ejection Problem; Ejection Problem

  THE DIB00 MODEL INTRAOCULAR LENS (IOL) DID NOT ADVANCE CORRECTLY AND THE IOL WAS EXPLANTED/REMOVED DURING THE SAME PROCEDURE. IT IS UNKNOWN IF A BACK-UP IOL WAS IMPLANTED. PATIENT PROGNOSIS POST-PROCEDURE IS ALSO UNKNOWN. THE 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 23772246 ↗
• InjuryDec 9, 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 IMPLANTED INTO THE PATIENT¿S LEFT EYE. THE PATIENT EXPERIENCED DYSPHOTOPSIA. REPORTEDLY, THE SYMPTOMS PERSISTED APPROXIMATELY 3 AND A HALF MONTHS. THE IOL WAS EXPLANTED DURING A SECONDARY PROCEDURE. AN UNPLANNED INCISION ENLARGEMENT AND SUTURES WERE REQUIRED. THERE WAS NO VITRECTOMY NEEDED. THE PATIENT HAS FULLY RECOVERED. THE CUSTOMER DECLINED TO PROVIDE PATIENT DEMOGRAPHIC DATA DUE TO DATA PRIVACY LEGISLATION. NO FURTHER INFORMATION IS AVAILABLE REGARDING THIS EVENT.

  Patient problems: Visual Disturbances

  MAUDE report 23764710 ↗
• MalfunctionDec 3, 2025Break; Break

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAD A DEFECTIVE HAPTIC THAT WAS OBSERVED DURING THE INSERTION OF THE DEVICE INTO THE OPERATIVE EYE. THERE WAS PATIENT CONTACT, HOWEVER, THE EXTENT OF PATIENT CONTACT IS UNKNOWN. THE PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708074 ↗
• InjuryNov 20, 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 IMPLANTED INTO THE PATIENT¿S RIGHT EYE. THE PATIENT EXPERIENCED INTOLERABLE MYOPIA. THE CUSTOMER IS UNSURE WHEN THEY FIRST COMPLAINED. THERE WERE NO OTHER ADVERSE EVENTS AND NO PATIENT INJURY. PRE-OPERATIVE DISTANCE VISION WAS REPORTED AS 20/30. THEIR POST-OPERATIVE NEAR VISION WAS REPORTED AS 20/25. THERE IS NO FURTHER INFORMATION REGARDING THIS EVENT.

  Patient problems: Visual Disturbances

  MAUDE report 23612996 ↗
• InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER THAT A DIB00 +20.0 INTRAOCULAR LENS (IOL) WAS IMPLANTED. THE PATIENT EXPERIENCED DIFFICULTY ADAPTING TO MONOVISION AND WAS STRUGGLING WITH DAILY ACTIVITIES. THE PRE-OPERATIVE VISION WAS 20/25 WITH -2.25/-2.50*90, AND THE POST-OPERATIVE VISION IS 20/20 WITH -2.25/-2.25*85. THE LENS WAS EXPLANTED DURING A SECONDARY SURGERY AND REPLACED WITH THE SAME MODEL BUT A LOWER DIOPTER J&J LENS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 23097763 ↗
• InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DIB00 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). POST-OPERATIVELY, THE PATIENT HAD PERSISTENT ANTERIOR CHAMBER REACTION (AC RXN) IN BOTH EYES DESPITE AN UNCOMPLICATED CATARACT SURGERY. THE DOCTOR BELIEVES THE ANTERIOR TILT OF THE HAPTICS AND SLIGHTLY LARGER HAPTIC WIDTH ARE CAUSING MORE CILIARY BODY-TO-HAPTIC TOUCH INDUCING THIS CHANGE. IN THIS PATIENT HAPTIC-CILIARY BODY BAND (CBB) TOUCH WAS CONFIRMED WITH ULTRASOUND BIOMICROSCOPY (UBM) AND THE DOCTOR OBSERVED NEW PIGMENT DISPERSION TO THE IOL. PATIENT SYMPTOMS SIGNIFICANTLY INTERFERE WITH THE HER DAILY ACTIVITIES CAUSING DISCOMFORT AND PHOTOPHOBIA. PRE-OP UNCORRECTED AND BEST CORRECTED VISUAL ACUITY WAS 20/40 AND POST-OPERATIVE UNCORRECTED AND BEST-CORRECTED VISUAL ACUITY WAS 20/25 +1. THERE WAS NO PATIENT INJURY DURING THE INITIAL PROCEDURES. AN IOL EXCHANGE IS SCHEDULED FOR (B)(6) 2025. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Eye Pain; Inflammation; Unspecified Eye / Vision Problem; Uveitis; Visual Disturbances

  MAUDE report 23040071 ↗
• MalfunctionAug 29, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE INNER BOX OF THE DIB00 MODEL INTRAOCULAR LENS (IOL) WAS RECEIVED DAMAGED, IT WAS WRINKLED, BENT AND, THE STICKER WAS RIPPED. THE CORRUGATED OUTER BOX HAD NO ISSUES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22929204 ↗
• MalfunctionAug 13, 2025Break; Break

  IT WAS REPORTED THAT A PRELOADED INTRAOCULAR LENS (IOL) SHOWED THAT BEFORE INSERTION, IT WAS NOTICED THAT THE LEADING HAPTIC WAS NOT CORRECT. THERE WAS NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED WITH THE SAME MODEL AND DIOPTER IOL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22798404 ↗
• InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LENS WAS REMOVED DURING THE SAME PROCEDURE DUE TO A POSTERIOR CAPSULAR RENT, MAKING LONG-TERM PLACEMENT UNSAFE. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 22777969 ↗
• InjuryJul 18, 2025Break; Break

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL TECNIS ENHANCE INTRAOCULAR LENS (IOL) WAS DEFECTIVE THAT RESULTED IN THE RESCHEDULING OF A PATIENT PROCEDURE. UPON FOLLOW-UP IT WAS STATED THAT THERE WAS A VITRECTOMY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22549882 ↗
• MalfunctionJul 2, 2025Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS HAD A CRACK IN THE MIDDLE, OCCURRED DURING PREPARATION. THE LENS WAS DIFFICULT TO ADVANCE WHICH OTHERWISE IS USUALLY EASY. IT WAS DECIDED TO INJECT IT INTO THE EYE AS SURGEONS HAD EXPERIENCED IT BEFORE WHERE DIFFICULTY ADVANCING IS CORRELATED WITH A LENS ISSUE. THE LENS WAS REMOVED FROM THE CARTRIDGE AND FOUND IT WAS CRACKED IN THE MIDDLE. LENS WAS HANDED OFF WELL BUT IT FELL ON THE FLOOR OF THE OPERATING ROOM AND WAS THEN UNABLE TO LOCATE IT. LENS IS NOT ABLE FOR RETURN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22387339 ↗
• MalfunctionJun 12, 2025Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT THE PRELOADED LENS WAS WASTED BECAUSE IT DID NOT ADVANCE AND BECAME BENT. ADDITIONAL INFORMATION REVEALED THAT THERE WERE NO PATIENT ISSUES. THE PROCEDURE WAS COMPLETED WITH ANOTHER J&J LENS OF THE SAME DIOPTER AND TYPE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22191758 ↗
• MalfunctionMay 28, 2025Break; Break

  IT WAS REPORTED THAT DURING A PRIOR INSERTION OF A PRE-LOADED INTRAOCULAR LENS, IT WAS NOTED THAT THE IMPLANT APPEARED DEFECTIVE. THERE WAS NO PATIENT CONTACT. DIRECTIONS OF USE WERE FOLLOWED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22102342 ↗
• MalfunctionMay 16, 2025Contamination; Contamination

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL LENS WAS INSERTED AND IT WAS DISCOVERED THAT THE IOL HAD A WHITE OILY SUBSTANCE ON THE FRONT. THE IOL WAS REMOVED DURING THE SAME PROCEDURE AFTER THE EVENT WAS OBSERVED POST-INSERTION. IT WAS REPLACED DURING THE SAME PROCEDURE WITH ANOTHER J&J LENS OF THE UNKNOWN MODEL AND DIOPTER. THERE WAS NO INJURY AND NO FURTHER INTERVENTION WAS REQUIRED. THE PATIENT FULLY RECOVERED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22039949 ↗
• InjuryApr 25, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  THE CUSTOMER REPORTED THAT WHEN ATTEMPTING TO INSERT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) INTO THE PATIENT¿S EYE THEY MET RESISTANCE. A VITRECTOMY WAS REQUIRED. A BACKUP IOL WAS USED TO COMPLETE THE PROCEDURE. REPORTEDLY, THE ISSUE IS NOT USE ERROR. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21914615 ↗
• MalfunctionMar 18, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT DURING IMPLANTATION A CRACK WAS NOTICED IN THE PRELOADED INTRAOCULAR LENS(IOL). THE CRACK IN THE LENS WAS NOT DO TO ERROR. THE LENS WAS PARTIALLY INSERTED. THERE WAS NO PATIENT INJURY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21637964 ↗
• MalfunctionFeb 11, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL LENS HAD A MECHANICAL COMPLICATION. THE LENS WAS REMOVED AND REPLACED DURING THE SAME SURGICAL PROCEDURE WITH ANOTHER LENS OF THE SAME MODEL AND DIOPTER, A J&J IOL. NO INJURY OR ADDITIONAL INTERVENTION WAS REQUIRED. THE PATIENT IS DOING WELL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21358967 ↗
• MalfunctionFeb 7, 2025Break; Break

  THE COMPLAINT INVOLVES A DAMAGED DIB00 LENS IT WAS NOTED THE LENS HAD A CHIP AT THE EDGE OF THE OPTIC AFTER INSERTION DURING A SURGICAL PROCEDURE IN PATIENT'S RIGHT EYE. THE LENS WAS LEFT IN PLACE. ADDITIONAL INFORMATION WAS RECEIVED, THERE WAS NO SECONDARY SURGICAL INTERVENTION, AND PATIENT WAS DOING WELL POST-OP DAY 1. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21339710 ↗
• MalfunctionDec 6, 2024Scratched Material; Scratched Material

  IT WAS REPORTED BY SURGEON THAT THERE WERE IMPERFECTIONS IN THE PRELOADED INTRAOCULAR LENS(IOL) LIKE SCUFFS THAT WERE NOTICED WHILE HYDRATING THE STROMA. THERE WAS NO PATIENT INJURY. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT IT WAS NOT KNOWN HOW THE SCUFFS ON THE LENS WERE FORMED. THERE WERE NO ANY VISUAL ISSUES EXPERIENCED BY THE PATIENT. THE LENS WAS NOT EXPLANTED. THERE WAS NO USE ERROR. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20872748 ↗
• MalfunctionOct 4, 2024Crack; Crack

  IT WAS REPORTED THAT WHEN THE SURGEON WAS ABLE TO IMPLANT THE PRELOADED INTRAOCULAR LENS (IOL) INTO THE PATIENT'S EYE, THE SURGEON NOTICED THAT THE CARTRIDGE WAS CRACKED AND HAD A ROUGH/SHARP EDGE AT THE TIP OF THE CARTRIDGE. THERE WAS NO PATIENT HARM. BSS OR OVD WAS USED TO HYDRATE THE PRELOADED DEVICE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20377607 ↗
• MalfunctionSep 19, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE MONOFOCAL INTRAOCULAR LENS (IOL) TORE IN THE INJECTOR. THERE WAS NO PATIENT CONTACT WITH THE IOL OR CARTRIDGE; THEREFORE, DID NOT AFFECT A PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP/REPLACEMENT IOL. IT WAS NOTED THAT THE DAMAGE WAS NOT DUE TO USE ERROR. IT WAS CONFIRMED THAT CARTRIDGE LUBRICATION/BALANCE SALT SOLUTION (BSS) WITH NO ADDITIVES AND AT ROOM TEMPERATURE WAS USED. IT WAS INDICATED THAT THE INITIAL MOVEMENT OF THE LENS IS PERFORMED BY SCRUB WHICH IS UNINTERRUPTED ONCE THE LENS PASSED THE DWELL POSITION AND WHEN ADVANCING THE LENS THEY ARE MAKING TWIST (SMALL ¼ TWIST). THE LENS OR CARTRIDGE ARE NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20260700 ↗