TECNIS SIMPLICITY DIB00 (REF DIB00U0180)Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 05050474731714), received between Oct 18, 2021 and Sep 1, 2026 — classified as 8 injuries, 22 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a preloaded monofocal intraocular lens (IOL) was fully implanted and subsequently removed during the same surgical procedure due to a posterior capsule rupture. A vitrectomy and sutures were required. The procedure was completed successfully using a replacement non-Johnson & Johnson lens (Model: MA60AC, Serial Number: (b)(6)). The lens and cartridge came into contact with the patient's left eye. The physician indicated that the device did not cause or contribute to the event. The patient's outcome was reported as fine. Additional information received confirmed that the posterior capsule rupture occurred after implantation of the intraocular lens (IOL). The lens was successfully injected into the capsular bag, and the trailing haptic was positioned using a Sinskey hook. During removal of the residual viscoelastic with an irrigation/aspiration device, a posterior capsule rupture occurred. The physician did not identify any issues with the lens, cartridge, or implantation process that may have contributed to the event. Furthermore, no preexisting patient conditions were identified as contributing factors.As a result of the posterior capsule rupture, an unplanned a

  Patient problems: Capsular Bag Tear

  MAUDE report 50554029 ↗
• InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A REFRACTIVE ERROR WITH A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) IN THE RIGHT EYE. THE ISSUE WAS FIRST IDENTIFIED DURING A POST-OPERATIVE (OP) EXAMINATION. BEST CORRECTED VISUAL ACUITY (BSCVA) PRE-OP WAS 20/50 AND BSCVA POST-OP WAS 20/80. AN IOL EXCHANGE WAS PERFORMED AND REPLACED WITH ANOTHER JOHNSON & JOHNSON LENS, MODEL DIB00 19.5 DIOPTER. THERE WAS NO UNPLANNED VITRECTOMY OR UNPLANNED INCISION ENLARGEMENT REQUIRED. THERE WAS NO DELAY IN PROCEDURE. THE PATIENT OUTCOME IS UNKNOWN AT THIS TIME. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 23599043 ↗
• InjuryAug 26, 2025Use of Device Problem; Mechanical Jam; Use of Device Problem; Mechanical Jam

  VIA E-MAIL IT WAS REPORTED THE DIB00 MODEL INTRAOCULAR LENS (IOL) WAS WASTED DUE TO LOADING ISSUES. HOWEVER, THE ATTACHED COMPLAINT INTAKE FORM INDICATED THE IOL WAS EXPLANTED IN SECONDARY SURGICAL PROCEDURE FROM THE PATIENT'S OCULAR SINISTER (LEFT EYE), SUTURES WERE REQUIRED, AND THE IOL DIRECTIONS WERE NOT FOLLOWED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 22900997 ↗
• InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL LENS WAS EXPLANTED DUE TO UNKNOWN PATIENT COMPLAINTS. THE LENS WAS REMOVED AND REPLACED WITH AN IOL OF THE SAME MODEL BUT DIFFERENT DIOPTER DURING A SECONDARY SURGICAL PROCEDURE. THE PATIENT POST-OP STATUS IS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 22128417 ↗
• MalfunctionApr 1, 2025Ejection Problem; Ejection Problem

  DURING IMPLANTATION, DUE TO THE WOUND NOT BEING LARGE ENOUGH, THE PRE-LOADED DIB00 MODEL INTRAOCULAR LENS (IOL) POPPED OUT OF THE EYE WHILE TRYING TO MAKE IT FIT AND DAMAGING THE LENS. THE SAME PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACK-UP DIB00 18.0 DIOPTER IOL THAT WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). THERE WAS NO SERIOUS PATIENT INJURY, NO SUTURES, AND NO VITRECTOMY HOWEVER, THE INCISION WAS ENLARGED DURING THE PROCEDURE. PATIENT PROGNOSIS POST-PROCEDURE WAS REPORTED AS GOOD. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 21749256 ↗
• MalfunctionMar 21, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED AS A WRONG LENS WAS IMPLANTED INTO THE PATIENT'S EYE. PATIENT HAD NO ADVERSE EFFECTS. FROM ADDITIONAL IT WAS LEARNT THAT THE LENS WAS REMOVED IN A SECONDARY PROCEDURE AND REPLACED WITH A CORRECT LENS. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21664916 ↗
• MalfunctionFeb 24, 2025Break; Break

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS DAMAGED. THE IOL HAD A HOLE WHICH WAS VISIBLE UNDER A MICROSCOPE. THE IOL WAS CUT OUT OF THE EYE, REMOVED AND REPLACED DURING THE SAME PROCEDURE. THE SURGERY WAS COMPLETED WITH A BACKUP LENS OF THE SAME MODEL AND DIOPTER. THERE WERE NO COMPLICATIONS SUCH AS A CAPSULE TEAR, VITRECTOMY, INCISION ENLARGEMENT OR SUTURES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21454510 ↗
• MalfunctionFeb 11, 2025Break; Break

  IT WAS REPORTED THAT AFTER IMPLANTING A MONOFOCAL INTRAOCULAR LENS (IOL) INTO A PATIENT'S LEFT EYE, THE DOCTOR OBSERVED A CRACK AT THE HAPTIC OPTIC JUNCTION. THE LENS WAS SUBSEQUENTLY EXPLANTED AND REPLACED WITH ANOTHER LENS OF THE SAME MODEL AND DIOPTER. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED. THE DOCTOR INDICATED THAT THIS WAS NOT THE FIRST TIME THAT THIS ISSUE HAS OCCURRED TO HIM. THIS REPORT PERTAINS TO THE ISSUE REPORTED WITH THE DIB00 LENS, SN (B)(6). A SEPARATE REPORT IS BEING SUBMITTED FOR THE EARLIER INCIDENT WHICH THE DOCTOR EXPERIENCED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21352205 ↗
• MalfunctionDec 11, 2024Mechanical Jam; Scratched Material; Mechanical Jam; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS DEFECTIVE; UPON EJECTION, THE LENS CAME OUT SCRATCHED AND WAS UNABLE TO BE USED FOR THE PATIENT. THROUGH FOLLOW UP, IT WAS LEARNED THAT THE INCIDENT OCCURRED IN (B)(6) 2024 (NO SPECIFIC DATE WAS PROVIDED). ANOTHER JOHNSON & JOHNSON LENS WITH THE SAME MODEL AND DIOPTER WAS IMPLANTED. THE PROBLEM WAS NOT CAUSED BY USER ERROR, AND THERE WAS NO PATIENT CONTACT. NO MEDICAL OR SURGICAL INTERVENTIONS WERE NECESSARY. DURING THE PROCEDURE, THE CUSTOMER USED OPHTHALMIC VISCOSURGICAL DEVICE (OVD), WHICH WAS ALLOWED TO ACCLIMATIZE FULLY TO OPERATING ROOM (OR) TEMPERATURE. THERE WAS A DELAY IN THE SURGERY BEFORE ATTEMPTING TO ADVANCE THE LENS (TIME UNKNOWN), AND THE LENS WAS ALREADY STUCK WHEN TRYING TO ADVANCE IT. THE LENS WAS POSITIONED CLOSER TO THE TIP OF THE CARTRIDGE THAN USUAL. THE CUSTOMER BELIEVES THAT A MANUFACTURING ERROR CAUSED THE ISSUE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20904077 ↗
• InjuryNov 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGERY CENTER REPORTED OF SOMETHING IN THE EYE CAUSING INFLAMMATION IN THREE PATIENTS WHICH WERE IMPLANTED WITH THE MONOFOCAL INTRAOCULAR LENSES (IOLS). THAT DURING THE POST-OP EXAMINATION, THE DOCTOR NOTICED SOMETHING GOING ON WITHIN EYE. IT IS UNKNOWN IF THE ISSUE SIGNIFICANTLY AFFECTED PATIENTS' DAILY ACTIVITIES. TREATED WITH STEROIDS AND CONTINUED EVALUATION OF EYE. ON (B)(6) 2024, THE DOCTOR CONFIRMED THAT ALL PATIENTS ARE DOING WELL AND RECOVERING FROM POST-OP IRITIS RECURRENCE. NO PRODUCT IS BEING RETURNED. NO FURTHER INFORMATION WAS PROVIDED. THIS EMDR REPORT PERTAINS TO PATIENT #3. SEPARATE REPORTS ARE BEING SUBMITTED FOR THE OTHER TWO PATIENTS.

  Patient problems: Uveitis

  MAUDE report 20805997 ↗
• MalfunctionMay 3, 2024Break; Break

  IT WAS REPORTED THAT AN EYHANCE INTRAOCULAR LENS (IOL) LEAD HAPTIC WAS BROKEN DURING HANDLING PRIOR TO INSERTION, WHEN PACKAGE WAS OPENED. THERE WAS NO PATIENT CONTACT. SURGERY COMPLETED SUCCESSFULLY USING THE BACK-UP IOL. THE DIRECTIONS FOR USE (DFU) WAS FOLLOWED, NO UNPLANNED VITRECTOMY, UNKNOWN IF WITH INCISION ENLARGEMENT AND SUTURES. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19240729 ↗
• MalfunctionJan 17, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE DOCTOR OBSERVED A ¿PARACENTRAL INDENTATION¿ IN THE PRELOADED INTRAOCULAR LENS (IOL) WHEN IMPLANTED. THE LENS WAS LEFT IN THE PATIENT'S EYE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18527389 ↗
• InjuryDec 8, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED AN UNKNOWN MODEL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE DUE TO DOCTOR COMPLAINTS OF WRONG DIOPTER SIZE. THE FOLLOWING ARE ALL UNKNOWNS: REPLACEMENT LENS INFORMATION, MEDICAL OR SURGICAL INTERVENTION, AND PATIENT STATUS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Eye Injury

  MAUDE report 18289061 ↗
• MalfunctionNov 29, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON(JNJ) INTRAOCULAR LENS (IOL) HAD A SCRATCH. THE DOCTOR NOTICED THE SCRATCH IN THE MIDDLE OF THE LENS AFTER IT WAS IMPLANTED IN THE PATIENT'S RIGHT EYE. DOCTOR EXPLANTED THE LENS BY CUTTING IT IN HALF. A NEW LENS OF THE SAME MODEL AND DIOPTER WAS THEN INSERTED. THERE WERE NO COMPLICATIONS SUCH AS CAPSULE TEAR, UNPLANNED VITRECTOMY OR SUTURES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18225389 ↗
• MalfunctionNov 22, 2023Crack; Mechanical Jam; Crack; Mechanical Jam

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS STUCK IN THE CARTRIDGE. THERE WAS PATIENT CONTACT. IT WAS NOTED BY THE SALES REPRESENTATIVE THAT THE TIP OF THE CARTRIDGE WAS BENT OUT OF THE BOX. THE ISSUE WAS OBSERVED WHEN INSERTING INTO THE EYE. THE LENS WAS NOT FULLY IMPLANTED. NO VITRECTOMY WAS PERFORMED AND THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18191148 ↗
• MalfunctionOct 26, 2023Crack; Crack

  IT WAS REPORTED WHILE TRYING TO ADVANCE THE DIB00 MODEL INTRAOCULAR LENS (IOL) THE CARTRIDGE SPLIT OPEN, END OF THE INJECTOR CRACKED APART, AND THERE WAS PATIENT CONTACT. THE REPORTED ISSUE WAS NOT RELATED TO USE ERROR AND THERE WAS NO MEDICAL/SURGICAL INTERVENTIONS. IT WAS CONFIRMED OPHTHALMIC VISCOSURGICAL DEVICE (OVD-VISCOELASTIC) WAS USED AND ALLOWED TO FULLY ACCLIMATE TO OPERATING ROOM TEMPERATURE. THERE WAS NO DELAYS IN THE SURGERY PRIOR TO ATTEMPTING TO ADVANCE THE IOL. THE IOL DID NOT GET STUCK WHILE ADVANCING NOR WAS THE IOL POSITIONED CLOSER TO THE CARTRIDGE TIP THAN NORMAL. ANOTHER IOL WITH THE SAME MODEL AND DIOPTER WAS IMPLANTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18017271 ↗
• MalfunctionSep 11, 2023Break; Break

  IT IS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS CHIPPED. THE PRODUCT IS BEING RETURNED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17726528 ↗
• MalfunctionJun 6, 2023Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT A PRELOADED INTRAOCULAR LENS (IOL) MISFIRED. THERE WAS PATIENT CONTACT WITH CARTRIDGE TIP. IT WAS STATED THAT THERE WAS IOL STUCK IN CARTRIDGE. NO INCISION ENLARGEMENT, NO VITRECTOMY, NO PRESCRIBED MEDS GIVEN. NO PATIENT INJURY, PATIENT WELL POST-OP. BACK-UP IOL USED TO COMPLETE THE SURGERY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17068472 ↗
• MalfunctionMay 24, 2023Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR (IOL) WAS FULLY INSERTED AND REMOVED DURING THE SAME PROCEDURE DUE TO SHUTTER (SHOOTER), INSERTION DEVICE DEFECT AND LENS DEFECT. THE ISSUE WAS NOTICED AFTER THE INSERTION OF THE LENS INTO THE EYE. THERE WAS AN INCISION ENLARGEMENT. ANOTHER JOHNSON & JOHNSON LENS OF THE SAME MODEL AND DIOPTER WAS IMPLANTED IN THE PATIENT¿S LEFT EYE AS A REPLACEMENT. THE PATIENT OUTCOME WAS NOT PROVIDED. THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 16997186 ↗
• MalfunctionApr 12, 2023Crack; Crack

  IT WAS REPORTED THAT A CUSTOMER WITH PATIENT CONTACT HAD CARTRIDGE TIP CRACKED/DEFORMED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16725796 ↗
• MalfunctionFeb 15, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THE PRE-LOADED DIB00 INTRAOCULAR LENS (IOL) WAS SCRATCHED AND THERE WAS CONTACT WITH PATIENT'S OCULAR DEXTER (RIGHT EYE) DURING THE SURGERY. THERE WAS NO PATIENT HARM. THROUGH FOLLOW-UP ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO SUTURE(S), AND NO VITRECTOMY. THE SAME PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER DIB00 18.0 DIOPTER LENS. PATIENT OUTCOME POST-PROCEDURE WAS REPORTED AS GOOD. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16383572 ↗
• MalfunctionOct 24, 2022Crack; Crack

  IT WAS REPORTED THAT THE SURGEON NOTICED A CRACK IN THE PRELOADED CARTRIDGE WHEN STARTING TO INSERT THE INTRAOCULAR LENS (IOL) INTO PATIENT'S LEFT EYE. ONLY THE CARTRIDGE TIP HAD PATIENT CONTACT WITH THE EYE. THE PROCEDURE WAS COMPLETED USING ANOTHER JOHNSON & JOHNSON LENS, MODEL ZCB00 18.0 DIOPTER. NO OTHER INTERVENTION WAS REQUIRED. THE PATIENT OUTCOME WAS NOT PROVIDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15659070 ↗
• MalfunctionOct 20, 2022Crack; Crack

  IT WAS REPORTED THAT THE SURGEON NOTICED A CRACK IN THE PRELOADED CARTRIDGE WHEN STARTING TO INSERT THE INTRAOCULAR LENS (IOL) INTO PATIENT'S LEFT EYE. THE SECOND PRELOADED DEVICE USED TOO HAD SIMILAR ISSUE THAT THE CARTRIDGE CRACKED. ONLY THE CARTRIDGES HAD PATIENT CONTACT WITH THE EYE IN BOTH THE CASES. THE PROCEDURE WAS COMPLETED USING ANOTHER LENS OF DIFFERENT MODEL, BUT OF SAME DIOPTER AND NO OTHER INTERVENTION WAS REQUIRED. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT CAPTURES THE SECOND LENS MENTIONED ABOVE AND A SEPARATE REPORT IS BEING SUBMITTED TO CAPTURE THE FIRST LENS MENTIONED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15643493 ↗
• MalfunctionJun 24, 2022Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS OVERRODE BY THE PUSHER. THE SURGEON PULLED BACK THE PUSHER AND WAS ABLE TO REENGAGE THE LENS. ALTHOUGH THE LENS WAS SCUFFED, IT WAS DEPLOYED INTO THE PATIENT'S OPERATIVE EYE. THE LENS REMAINS IMPLANTED INSIDE THE EYE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14810672 ↗
• MalfunctionMar 10, 2022Break; Material Fragmentation; Misassembled; Device Difficult to Setup or Prepare; Break; Material Fragmentation; Misassembled; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE FIRST INTRAOCULAR LENS (IOL) WAS PRELOADED INCORRECTLY. THAT RESISTANCE WAS NOTICED WHILE INSERTING THE LENS WITH PRE-LOADED INJECTOR INTO THE PATIENT¿S RIGHT EYE, THE HAPTIC WAS COMPLETELY BROKEN OFF AND THE OPTIC WAS DAMAGED. THE LENS WAS EXPLANTED, CAME OUT BROKEN IN 3 PIECES AND A SECOND IOL WITH THE SAME MODEL AND DIOPTER WAS INSERTED DURING THE SAME PROCEDURE WITHOUT USING THE PRELOADED INJECTOR. NO ADDITIONAL SURGICAL INTERVENTIONS WERE REQUIRED. THE PATIENT IS DOING WELL POST-OP AND NO INJURY WAS REPORTED. IT WAS NOTED THAT THE LENS WAS DISCARDED AFTER IT WAS EXPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13727462 ↗