TECNIS SIMPLICITY DCB00 (REF DCB0000180)Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 05050474636040), received between Jan 6, 2021 and Sep 17, 2026 — classified as 6 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Break

  It was reported that the preloaded, monofocal, Intraocular Lens (IOL) was faulty. No further information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50797178 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a posterior capsule tear occurred during implantation of a preloaded monofocal intraocular lens (IOL). The complaint device is not available for return, as it was disposed of. No additional information was provided.

  Patient problems: Capsular Bag Tear

  MAUDE report 50000294 ↗
• MalfunctionMay 22, 2026Contamination

  IT WAS REPORTED THAT, DURING A CATARACT EXTRACTION WITH A SINGLE PIECE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) IMPLANTATION INTO THE PATIENT'S RIGHT EYE. A SMALL BLACK THREAD WAS OBSERVED HANGING FROM THE INCISION SITE AFTER IMPLANTATION. UPON FURTHER INSPECTION UNDER THE MICROSCOPE, THE THREAD WAS IDENTIFIED AS BEING ATTACHED TO THE HAPTIC OF THE IMPLANTED IOL. THE THREAD WAS REMOVED BY CUTTING IT FREE FROM THE HAPTIC, AND THE PHYSICIAN CONTINUED TO EVALUATE THE LENS, DETERMINING THAT THERE WERE NO CONCERNS WITH THE IOL FOLLOWING REMOVAL OF THE THREAD. THE PRODUCT WAS DISCARDED, AND NO PATIENT OR USER HARM WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25257853 ↗
• MalfunctionApr 21, 2026Break

  IT WAS REPORTED THAT A SINGLE PIECE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS OPENED BUT NOT USED DURING A CASE. THE IOL WAS CRACKED UPON OPENING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24934665 ↗
• MalfunctionMar 3, 2026Break

  IT WAS REPORTED THAT A CRACK WAS OBSERVED AT THE EDGE OF THE INTRAOCULAR LENS (IOL) HAPTIC AFTER THE LENS HAD BEEN IMPLANTED INTO THE PATIENT¿S EYE. THE IOL WAS NOT REPLACED. THE PROCEDURE WAS COMPLETED AFTER THE SURGEON ADJUSTED THE LENS POSITION. THERE WAS NO TREATMENT DELAY AND NO ADDITIONAL INTERVENTIONS WERE REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24500624 ↗
• MalfunctionJan 2, 2026Break; Failure to Advance

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAD A CRACK IN IT AND WOULD NOT ADVANCE. THE CRACK WAS NOT DUE TO A HANDLING ERROR. THERE WAS NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED USING A BACKUP IOL (DIB00 WITH THE SAME DIOPTER). THERE WERE NO UNPLANNED INTERVENTIONS AND SUTURES WERE NOT REQUIRED. THERE WAS NO PATIENT INJURY. THE PATIENT IS DOING WELL POST-OPERATIVELY WITH NO COMPLICATIONS. IT WAS REPORTED THAT THE DEVICE CONTRIBUTED TO THE EVENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23950356 ↗
• MalfunctionNov 21, 2025Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT DURING IMPLANTATION, A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) UNEXPECTEDLY SHOT OUT THROUGH THE INJECTOR TIP PRIOR TO INSERTION. THE LENS TOUCHED SURFACE OF THE EYE BUT WAS NOT INSERTED. THERE WAS A 2 MINUTE DELAY IN PROCEDURE. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. THE PATIENT'S CURRENT STATUS IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23618860 ↗
• MalfunctionNov 20, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS FOUND TO BE STIFF, AND THE HAPTICS WERE TAKING LONGER THAN USUAL TO UNFOLD IN THE EYE. THROUGH FOLLOW UP, WE LEARNED THAT ADDITIONAL SURGICAL MANEUVERS WERE REQUIRED TO POSITION THE IOL IN THE PATIENT'S EYE. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23610132 ↗
• MalfunctionSep 16, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT AFTER INTRAOCULAR LENS IMPLANTATION, THE OPTICAL SURFACE OF THE LENS WAS FOUND TO BE SCRATCHED. THEN THE LENS WAS IMMEDIATELY REMOVED AND REPLACED WITH THE SAME MODEL OF INTRAOCULAR LENS. THE SURGERY WAS SUCCESSFULLY COMPLETED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23069771 ↗
• MalfunctionJul 7, 2025Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE WITH A MONOFOCAL INTRAOCULAR LENS, THE LENS EXITED THE CARTRIDGE PREMATURELY AND WAS PARTIALLY INSERTED INTO THE PATIENT'S EYE. THE ISSUE HAPPENED DURING THE IMPLANTATION PROCESS. THIS RESULTED IN A DELAY OF APPROXIMATELY TWO MINUTES IN THE PROCEDURE. THE CUSTOMER VERIFIED THAT THE DIRECTIONS FOR USE HAD BEEN FOLLOWED CORRECTLY, AND NO UNPLANNED SURGICAL INTERVENTIONS SUCH AS VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22414713 ↗
• MalfunctionJun 16, 2025Scratched Material; Scratched Material

  AFTER THE DCB00 MODEL INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED, A MARK WAS DETECTED IN THE CENTRAL PART OF IOL, WHICH RESULTED IN PERFORMING AN INCISION ENLARGEMENT TO WITHDRAWAL THE LENS DURING THE SAME PROCEDURE. THE DOCTOR DID NOT USE A BACKUP LENS TO COMPLETE THE PROCEDURE AND THE PATIENT LEFT APHAKIC. ALTHOUGH PATIENT STATUS POST PROCEDURE IS UNKNOWN THERE IS NO INDICATION THAT MEDICAL INTERVENTION OR SURGICAL INTERVENTION WAS NECESSARY TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PREVENT PERMANENT DAMAGE TO A BODY STRUCTURE. PATIENT INFORMATION CANNOT BE PROVIDED DUE TO PERSONAL DATA PROTECTION POLICY/LEGISLATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22215424 ↗
• InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHEN THE SURGEON WAS INSERTING THE PRELOADED INTRAOCULAR LENS (IOL) INTO THE PATIENT'S EYE THE CAPSULE WAS TORN, SUBSEQUENTLY THE LENS WAS REMOVED. THE DOCTOR HAD ENLARGED THE INCISION TO REMOVE THE LENS AND SUTURED THE INCISION. THE PATIENT WAS SCHEDULED TO SEE RETINA SPECIALIST FOR VITRECTOMY. NO OTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 22070604 ↗
• MalfunctionMay 16, 2025Break; Ejection Problem; Break; Ejection Problem

  DURING INSERTION WHILE ADVANCING THE DCB00 MODEL INTRAOCULAR LENS (IOL), THE TIP OF THE DELIVERY SYSTEM SLIPPED OUT OF THE PATIENT'S EYE. IT WAS ALSO REPORTED THE LENS WAS DAMAGED AND IT WAS CONFIRMED THE LENS WAS NOT STUCK IN THE CARTRIDGE. THE PROCEDURE WAS COMPLETED USING ANOTHER J&J LENS WITH THE SAME MODEL AND DIOPTER THAT WAS IMPLANTED. THERE WAS NO MEDICAL INTERVENTION, NO PATIENT INJURY, AND NO SURGICAL INTERVENTION. PATIENT PROGNOSIS POST-PROCEDURE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22040871 ↗
• MalfunctionMay 9, 2025Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS DEFECTIVE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21998942 ↗
• InjuryMar 24, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS INSERTED AND A SCRATCH WAS NOTED AFTER INSERTION INTO THE PATIENT'S EYE. THE IOL WAS REMOVED AND A NEW LENS WAS PLACED. THE IOL CAME OUT IN SMALL PIECES; THEREFORE, THE LENS IS NOT AVAILABLE FOR DEVICE EVALUATION. THROUGH FOLLOW UP, IT WAS LEARNED THAT UNPLANNED SUTURES WERE USED, THE WOUND WAS EXTENDED; HOWEVER, A VITRECTOMY WAS NOT REQUIRED. THERE WAS A SLIGHT DELAY DURING THE PROCEDURE AS THE LENS HAD TO BE REMOVED AND REPLACED WITH ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) AS A REPLACEMENT. THE DELAY DID NOT AFFECT THE OVERALL FLOW OF THE DAY. THE REPLACEMENT LENS WAS SUCCESSFULLY IMPLANTED. THERE WAS NO PATIENT INJURY REPORTED. THE PATIENT WAS DISCHARGED THE SAME DAY, 30 MINUTES FOLLOWING THE SURGERY. NO OTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 21684662 ↗
• MalfunctionMar 12, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT THE HAPTICS OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WOULD NOT OPEN, THEY APPEARED STUCK. THE IOL WAS INTRODUCED INTO THE PATIENT'S EYE, BUT THE SURGEON WAS ABLE TO REMOVE IT AND REPLACE IT WITH ANOTHER 18.0D LENS. THE CUSTOMER INFORMED US THAT THERE HAS BEEN ISSUES WITH LENS OPENING IN THE PAST, BUT THIS LENS WOULD NOT OPEN AT ALL. THROUGH FOLLOW UPS, WE LEARNED THAT THE PATIENT HAD A HIGHER INTRAOCULAR PRESSURE POST OPERATIVELY WHICH REQUIRED TREATMENT AND FOLLOW UP. THE PATIENT WAS PRESCRIBED SOME EYE DROPS FOR THE PRESSURE. ALTHOUGH THE CORNEA WAS HAZY DURING THE PATIENT'S FOLLOW UP APPOINTMENT, THE PRESSURE WAS NORMAL. THE PATIENT HAS A FOLLOW UP APPOINTMENT IN 6 WEEKS. THE PATIENT IS REPORTED AS FINE NOW. THE CUSTOMER INDICATED THAT THERE WERE NO FURTHER INCIDENTS AT THE MOMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Corneal Clouding/Hazing; Intraocular Pressure Increased

  MAUDE report 21587481 ↗
• MalfunctionMar 10, 2025Break; Operating System Becomes Nonfunctional; Break; Operating System Becomes Nonfunctional

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) HAD A BROKEN LOOP AND THAT THERE WAS A PISTON SLIDING DEFECT. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21568215 ↗
• MalfunctionJan 7, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT A SCRATCH WAS OBSERVED ON THE MONOFOCAL INTRAOCULAR LENS (IOL) DURING THE SURGERY, ALTHOUGH THERE WAS NO PATIENT CONTACT WITH THE LENS. THE ORIGINALLY SCHEDULED PROCEDURE WAS COMPLETED ON THE SAME DAY. ACCORDING TO THE SURGEON'S ASSESSMENT, THE PRODUCT CONTRIBUTED TO THE EVENT. THE LENS HAS BEEN DISPOSED OF AND IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21088732 ↗
• InjuryDec 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S LEFT EYE DUE TO DYSPHOTOPSIA /GASH POST OPERATIVEY AND THE PATIENT WAS UNABLE TO TOLERATE THE LENS. . THE ISSUE WAS FIRST IDENTIFIED DURING THE POST-OPERATIVE EXAMINATION, WITH AFTER IMPLANTATION/APPLICATION OF LENS. THE VISUAL PROBLEMS WERE OBSERVED SHORTLY AFTER THE PROCEDURE. THE PATIENT WAS REPORTED TO HAVE EXPERIENCED TEMPORARY IMPAIRMENT AND WAS UNABLE TO PERFORM CERTAIN DAILY ACTIVITIES THAT WERE MANAGEABLE PRIOR TO SURGERY. THE LENS WAS EXPLANTED AND REPLACED WITH A NON JNJ LENS IN A SECONDARY PROCEDURE. THE BEST CORRECTED VISUAL ACUITY BSCVA) PRE-OPERATIVE WAS 20/40 AND THE BEST CORRECTED VISUAL ACUITY BSCVA) POST-OPERATIVE WAS 15/20. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. THE PATIENT HAD FULLY RECOVERED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 21049124 ↗
• MalfunctionDec 31, 2024Crack; Crack

  IT WAS REPORTED THAT PRELOADED MONOFOCAL INTRAOCULAR LENS WAS FAILED TO BE RELEASED DUE TO THE DEFECT OF THE CARTRIDGE TIP. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21049113 ↗
• MalfunctionNov 26, 2024Crack; Crack

  IT WAS REPORTED BY A SURGEON THAT THERE A PRELOADED MONOFOCAL INTRAOCULAR LENSES (IOL) HAD A BENT TIP. THE LENS WAS PARTIALLY INSERTED. THE ISSUE WAS FIRST IDENTIFIED DURING IMPLANTATION. THE PATIENT STATUS WAS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20776735 ↗
• MalfunctionNov 14, 2024Contamination; Contamination

  SEVERAL LINEAR FIBERS WERE NOTED WITHIN THE PRE-LOADED DCB00 MODEL CARTRIDGE AND WERE INJECTED INTO THE ANTERIOR CHAMBER ALONG WITH THE INTRAOCULAR LENS (IOL). THE DOCTOR WAS ABLE TO RETRIEVE THE FIBERS USING A 27 GAUGE CANNULA. THE FOLLOWING ARE ALL UNKNOWNS: DAILY ACTIVITIES SIGNIFICANTLY AFFECTED, INCISION ENLARGEMENT, SUTURE(S), VITRECTOMY, MEDICATION PRESCRIBED (OUTSIDE OF STANDARD CARE), IF MEDICAL ATTENTION WAS REQUIRED, AND PATIENT STATUS POST PROCEDURE. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT REMAINS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20688631 ↗
• MalfunctionOct 13, 2024Break; Ejection Problem; Break; Ejection Problem

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS DEFECTIVE. THERE WAS PATIENT CONTACT. THE LENS WAS REMOVED AND REPLACED FROM THE PATIENT'S RIGHT EYE DURING THE SAME PROCEDURE. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) WAS SUCCESSFULLY IMPLANTED AS A REPLACEMENT. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. THERE WAS NO OTHER MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PATIENT OUTCOME WAS REPORTED AS PATIENT IS DOING FINE WITHOUT ANY ISSUES. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20436568 ↗
• MalfunctionOct 3, 2024Crack; Ejection Problem; Crack; Ejection Problem

  IT WAS REPORTED THAT THE INJECTOR ON THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS DEFECTIVE. THE IOL WAS DEPLOYED IN A MORE VIOLENT MANNER THAN USUAL AND THAT IN THE PERIPHERAL PART IT LOOKED LIKE ¿SPLINTERS.¿ THE DOCTOR STATES THAT THE INJECTOR WAS NOT PERFECTLY SMOOTH AND THAT WHEN INSERTING THE LENS, HE OBSERVED A KIND OF SPLINTER IN ITS PERIPHERAL AREA. HE ALSO REPORTS THAT THE LENS DEPLOYED VIOLENTLY. THE CUSTOMER EXAMINED THE INJECTOR AND NOTED SOME IRREGULARITY AT THE TIP. THE LENS WAS PLACED IN THE PATIENT AND REMAINS IMPLANTED. WHEN THE DOCTOR SEES THE PATIENT, HE HOPES NOT TO HAVE ANY PROBLEMS SINCE THE DEFECT IS NOT IN THE OPTICS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20364212 ↗
• MalfunctionSep 19, 2024Material Opacification; Material Opacification

  IT WAS REPORTED THAT A DEFECT WAS DETECTED IN THE INTRAOCULAR LENS (IOL) AFTER IMPLANTATION. THE IOL WAS REMOVED AND REPLACED WITH A NEW LENS DURING THE SAME PROCEDURE WITHOUT FURTHER COMPLICATIONS. THROUGH FOLLOW-UP WE LEARNED THAT THE DEFECT WAS A SPOT IN THE CENTER OF THE LENS, WHICH RESULTED IN THE DECISION TO REPLACE IT WITH ANOTHER LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20261850 ↗