TECNIS SIMPLICITY DIB00 (REF DIB00U0155)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 05050474731660), received between Dec 10, 2021 and May 28, 2026 — classified as 3 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026Break

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS FOUND TO BE DEFECTIVE, DESCRIBED AS HAVING A LACERATION, DURING LOADING PRIOR TO CONTACT WITH THE PATIENT¿S LEFT EYE. THE LENS WAS NOT USED, AND NO PATIENT INJURY OR MEDICAL OR SURGICAL INTERVENTION OCCURRED. IT WAS INDICATED THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTED TO THE EVENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25325812 ↗
• InjuryJan 22, 2026Adverse 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. DURING A POST-OPERATIVE EXAMINATION, IT WAS NOTICED THAT THE PATIENT WAS EXPERIENCING BLURRY VISION AND NEEDED TO MOVE TO A TORIC LENS. THE PRE-OPERATIVE AND POST-OPERATIVE REFRACTION IS UNKNOWN, THEIR TARGET IS 20/20. THE DIRECTIONS FOR USE WERE FOLLOWED. THERE WAS NO VITRECTOMY OR DELAY IN PROCEDURE. REPORTEDLY, THE END USER DID NOT SEEK MEDICAL ATTENTION AND NO MEDICATION WAS PRESCRIBED. THE IOL WAS SUBSEQUENTLY EXPLANTED AND THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 24157540 ↗
• MalfunctionJan 22, 2026Scratched Material

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS SCRATCHED FROM THE PLUNGER/INJECTOR. THE ISSUE WAS NOTICED AFTER THE LENS WAS IMPLANTED. THE DOCTOR CUT OUT THE IOL AND REPLACED IT WITH MODEL DIB00 15.5 DIOPTER. IT IS UNKNOWN IF THE PATIENT OR USER WAS HARMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24142014 ↗
• 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 SINISTER (LEFT 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 ON (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 23040184 ↗
• MalfunctionJul 1, 2025Break; Break

  IT WAS REPORTED THAT A PRELOADED LENS HAD A CHIP. THE OPENED LENS MADE CONTACT WITH THE PATIENT. THE PATIENT IS GOOD AND STABLE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22379162 ↗
• MalfunctionMay 19, 2025Break; Break

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL LENS WAS DAMAGED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22049039 ↗
• MalfunctionFeb 7, 2025Break; Break

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) EDGE APPEAR TO BE WAS FRAYED. THE IOL REMAINS IMPLANTED. 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 21334621 ↗
• MalfunctionDec 6, 2024Material Opacification; Material Opacification

  IT WAS REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) WAS INSERTED, THE PHYSICIAN NOTICED A BLACK SPOT ON THE LENS. THE IOL HAD TO BE CUT OUT AND REMOVED. IT WAS REPLACED WITH ANOTHER JOHNSON & JOHNSON LENS. ADDITIONAL INFORMATION SUGGESTS THAT THE UNKNOWN BLACK SPOT COVERED PART OF THE LENS AND COULD POTENTIALLY IMPACT THE PATIENT'S VISION, BUT THE SPOT COULD NOT BE REMOVED. THERE WERE NO COMPLICATIONS FOR THE PATIENT. THE PATIENT IS DOING FINE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20872882 ↗
• MalfunctionNov 27, 2024Break; Break

  IT WAS REPORTED THAT THE SURGEON IMPLANTED A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) AND ONCE UNFOLDED, IT HAD A GIANT GOUGE OR FLAP ON THE POSTERIOR SIDE OF THE LENS. NO ISSUES WERE REPORTED WITH THE PRELOADED INJECTOR. LENS WAS REMOVED AND A NEW LENS WAS IMPLANTED IN THE SAME PROCEDURE. NO OTHER COMPLICATIONS. ADDITIONAL INFORMATION STATED THAT THE LENS WAS CUT UP AND DISPOSED OFF. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20801348 ↗
• MalfunctionSep 16, 2024Break; Break

  THERE WAS NO CAPSULE TEAR, UNPLANNED VITRECTOMY, OR SUTURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20233175 ↗
• MalfunctionSep 4, 2024Break; Material Discolored; Break; Material Discolored

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS DAMAGED. THE DAMAGE WAS NOTICED AFTER THE IMPLANTATION OF THE LENS IN THE PATIENT'S LEFT EYE. THE EDGE OF THE OPTIC APPEARED ROUGH AND WHITISH. BOTH THE IOL AND THE INSERTER WERE INCLUDED. THERE WAS PATIENT CONTACT, BUT THE PATIENT WAS NOT HARMED. THE LENS WAS OPENED BUT NOT USED. THERE WAS INCISION ENLARGEMENT AS THE RESULT OF IMPLANTATION. THE WAS NO VITRECTOMY PERFORMED. BSS AND OVD WERE USED AS A CARTRIDGE LUBRICANT WERE FULLY ACCLIMATIZED. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT THE LENS DAMAGE APPEARED TO BE A MANUFACTURING DEFECT. AT FIRST IT WAS THOUGHT THAT THE WHITISH DEFECT WAS ON THE CORTEX AND WHEN TRIED TO REMOVE IT, IT WAS REALIZED THAT THE WHITISH MATTER WAS INTEGRAL TO THE OPTIC EDGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACKUP LENS WITH THE SAME MODEL AND DIOPTER. THERE WAS NO PATIENT INJURY. NO OTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 20139143 ↗
• MalfunctionJan 22, 2024Break; Break

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAD DEFECTIVE. THERE IS NO INFORMATION ABOUT THE REPLACEMENT IOL. PATIENT WAS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18554702 ↗
• MalfunctionDec 4, 2023Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAD THE TRAILING HAPTIC STUCK IN THE INSERTER AND WOULD NOT RELEASE FULLY INTO THE EYE. THE SURGEON HAD TO USE ANOTHER INSTRUMENT TO GET THE TRAILING HAPTIC OUT TO FINISH THE PROCEDURE. DURING CATARACT SURGERY THE SURGEON INDICATED HE MAKES A 2.2MM INCISION SIZE. IT WAS ALSO REPORTED THAT THE SURGEON USED EITHER VISCOELASTIC OR BSS (BALANCED SALT SOLUTION) TO LUBRICATE THE LENS. SURGEON ALSO INDICATED HE ADVANCED THE LENS COMPLETELY AS THE DIAL WAS FLUSH TO THE BODY OF THE INSERTER. THE LENS REMAINS IMPLANTED. THE PATIENT IS FINE AND THE OUTCOME IS AMAZING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18263196 ↗
• MalfunctionJul 20, 2023Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS CRACKED/DAMAGED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17362832 ↗
• MalfunctionJun 29, 2023Mechanical Problem; Material Split, Cut or Torn; Mechanical Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) HAD A "FULL THICKNESS HORSE SHOE SHAPED TEAR IN IT." THE SURGEON CUT IT OUT AND REPLACED IT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17225620 ↗
• MalfunctionFeb 23, 2023Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT THE TRAILING HAPTIC OF THE DIB00 INTRAOCULAR LENS (IOL) WAS BROKEN UPON INSERTION INTO PATIENTS RIGHT EYE. LEADING HAPTIC WAS DISCOVERED TO BE BROKEN AS WELL DURING EXPLANTATION. ADDITIONAL INFORMATION RECEIVED STATED THAT THE TRAILING HAPTIC OF THE IOL WAS BROKEN OFF, IN ADDITION TO THE LEADING HAPTIC BEING SEVERED AT THE HAPTIC/OPTIC JUNCTION WHICH WAS NOTICED WHEN THE SURGEON WAS ROTATING THE IOL IN THE CAPSULAR BAG. THE IOL HAD TO BE CUT OUT AND REMOVED DURING THE CASE, AND THE SURGEON IMPLANTED ANOTHER DIB00 WITH NO ISSUE. THERE WAS NO USE ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16433027 ↗
• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH BILATERAL INTRAOCULAR LENSES (IOLS) VISITED HIS DOCTOR¿S OFFICE ON (B)(6) 2022, AND THE PATIENT WAS TOLD THAT BOTH LENSES WERE CLOUDY AND WOULD HAVE TO BE REMOVED. PATIENT CANNOT SEE CLEARLY. PATIENT IS OCCASIONALLY TAKING DROPS FOR DRY EYE. THROUGH FOLLOW-UP, THE PATIENT EXPLAINED THAT HE WAS NOT ABLE TO SEE CLEAR AND THE DOCTOR TOLD HIM IT WAS DUE TO HIS POUCH BEING CLOUDY LIKE A CATARACT. THE PATIENT STARTED NOTICING THE BLURRY VISION RIGHT AFTER THE RIGHT EYE WAS DONE, MAY TIME FRAME. THEREFORE, A YTTRIUM ALUMINUM GARNET (YAG) WAS PERFORMED ON BOTH EYES ON (B)(6) 2022. THE PATIENT CONFIRMED THAT THE INITIAL REPORT "OF OCCASIONALLY TAKING DROPS FOR DRY EYE" WERE STANDARD OF CARE DROPS POST SURGERY. THE PATIENT STATED THAT HE HAS HAD A HISTORY OF DRY EYE AND THINKS IT WAS DUE TO HIS LASIK PROCEDURE PERFORMED SOMETIME IN 1998 PRIOR TO IOL IMPLANT. HE HAS OCCASIONALLY BEEN TAKING OVER-THE-COUNTER (OTC) EYE DROPS FOR DRY EYE. THE PATIENT ALSO HAS HAD TEAR DUCT PLUGS TO HELP WITH THE DRY EYES WHICH WERE PERFORMED SOMETIME IN (B)(6) 2022. NO OTHER TREATMENTS HAVE BEEN PROVIDED AND THE LENSES REMAIN IMPLANTED. NO OTHER INFORMATION WAS PROVIDED. PATIE

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

  MAUDE report 15578224 ↗
• MalfunctionMay 17, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DEFECTIVE. IT IS UNKNOWN WHAT THE DEFECT WAS OR IF THERE WAS PATIENT CONTACT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14418228 ↗
• MalfunctionDec 10, 2021Failure to Fold; Inaccurate Delivery; Failure to Fold; Inaccurate Delivery

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) HAD FOLDING ISSUE. ADDITIONAL INFORMATION RECEIVED REVEALED THAT THE LENS POPPED OUT BEFORE GETTING IN THE EYE. ONLY THE CARTRIDGE TIP CONTACTED THE PATIENT'S LEFT EYE. ANOTHER LENS OF SAME MODEL AND DIOPTER (SERIAL (B)(4)) WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY AND NO OTHER INTERVENTION WAS REQUIRED. THE PATIENT WAS DOING GOOD POST-OPERATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12977630 ↗