TECNIS IOL ZCB00 (REF ZCB0000245)Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 05050474531802), received between Sep 8, 2016 and Sep 28, 2026 — classified as 32 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Visual Impairment

  MAUDE report 50926537 ↗
• MalfunctionOct 28, 2025Material Opacification; Material Opacification

  IT WAS REPORTED THAT DURING A FOLLOW-UP EXAMINATION, AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, THE SURGEON INITIALLY SUSPECTED POSTERIOR CAPSULE OPACITY. HOWEVER, THE ISSUE WAS LATER IDENTIFIED AS OPACIFICATION OF THE IOL ITSELF. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23410340 ↗
• InjuryAug 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A POSTERIOR CAPSULE RUPTURE WITH VITREOUS PROLAPSE WHEN PATIENT COUGHED. NO FURTHER INFORMATION IS PROVIDED.

  Patient problems: Capsular Bag Tear; Vitreous Loss

  MAUDE report 19996170 ↗
• InjuryJul 25, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT AFTER IMPLANTATION OF THE LENS, THE SURGEON WAS UNABLE TO MANIPULATE THE LENS TO CENTER DESPITE MULTIPLE ATTEMPT. TRIAMCINOLONE WAS INJECTED INTO THE ANTERIOR CHAMBER AND NOTED VITREOUS TRACKING TOWARDS THE SIDE PORT. CORNEAL WOUND EXTENDED AND THE POSTERIOR CAPSULE INTRAOCULAR LENS WAS EXTRACTED. THERE WAS POSTERIOR CAPSULE RUPTURE SUPERIORLY. ANTERIOR VITRECTOMY WAS DONE, AND THE ANTERIOR CAPSULE STILL INTACT. DOCTOR DECIDED TO IMPLANT THE SULCUS INTRAOCULAR LENS. THE LENS WAS STABLE. INCISION WAS ENLARGED AND SUTURES WAS PERFORMED. MEDICATION WAS PRESCRIBED. VISON PRE-OP WAS 6/38 AND POST-OP WAS 6/48. NO FURTHER INFORMATION AVAILABLE.

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

  MAUDE report 19830548 ↗
• MalfunctionMay 22, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE MONOFOCAL INTRAOCULAR LENS (IOL) HAD A SCRATCH WHICH WAS NOTICED AFTER INSERTION INTO THE PATIENT'S RIGHT EYE. THE IOL WAS REMOVED AND REPLACED IN THE SAME PROCEDURE WITH A DIFFERENT JOHNSON & JOHNSON MODEL LENS OF THE SAME DIOPTER. THERE WAS NO INJURY REPORTED. NO SURGICAL OR MEDICAL INTERVENTIONS WERE REQUIRED. THE PATIENT IS DOING WELL. THE PRODUCT IS AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19375608 ↗
• MalfunctionMay 9, 2024Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) HAD A SCRATCH AT THE 2-3 O¿CLOCK AREA. THE ISSUE WAS NOTICED AFTER THE IOL WAS IMPLANTED. THE DOCTOR REMOVED THE LENS AND REPLACED IT WITH A BACKUP OF THE SAME MODEL AND DIOPTER. THERE WERE NO ADDITIONAL COMPLICATIONS SUCH AS SUCH AS A CAPSULE TEAR, VITRECTOMY, OR INCISION ENLARGEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19282748 ↗
• InjuryFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE, THE SURGEON NOTICED THE ZONULAR FIBERS LOOSE AND NOT STABLE. THERE WAS A CAPSULE TEAR. IT WAS DECIDED THAT IT WAS BETTER TO PUT A 3 PIECE LENS IN INSTEAD. THE SURGEON CUT AND REMOVED LENS. ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (DIFFERENT MODEL, ZA9003, DIFFERENT DIOPTER OF +24.0). TRIAMCINOLONE SUSPENSION WAS USED TO VISUALIZE THE VITREOUS AND MIOSTAT WAS INJECTED IN THE ANTERIOR CHAMBER TO CONSTRICT THE PUPIL. AN ANTERIOR VITRECTOMY WAS PERFORMED AND A SUTURE WAS ADDED TO CLOSE THE WOUND. THE SUTURE AND VITRECTOMY WERE UNPLANNED. PATIENT IS DOING OK POST-OPERATIVELY AND WANTS TO HAVE THE OTHER EYE DONE. VISUAL ACUITY IS 20/40 WITH NO IMPROVEMENT (NI). INTRAOCULAR PRESSURE (IOP) OF 25. THE PATIENT WAS SCHEDULED TO HAVE A GONIOTOMY DONE AFTER THE CATARACT CASE BUT THE SURGEON CANCELLED IT. THERE WAS NO MALFUNCTION OR ISSUE WITH THE IOL. THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 16418733 ↗
• InjuryAug 2, 2022Inaccurate Delivery; Scratched Material; Inaccurate Delivery; Scratched Material

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) DID NOT DEPLOY FROM THE INSERTER CORRECTLY AND THE LENS WAS SCRATCHED. THE HAPTIC WAS IN WHEN THE DOCTOR REALIZED THE LENS WAS SCRATCHED. INCISION ENLARGEMENT AND SUTURE(S) WERE REQUIRED. PATIENT HAS FULLY RECOVERED. THROUGH FOLLOW-UP ADDITIONAL INFORMATION WAS RECEIVED STATING THE SAME PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACK-UP LENS WITH THE SAME MODEL AND DIOPTER SIZE, WHICH WAS IMPLANTED IN THE PATIENT¿S LEFT EYE. PATIENT REPORTED AS STABLE POST-PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 15153996 ↗
• MalfunctionApr 19, 2022Break; Break

  IT WAS REPORTED THAT IOL HAD BROKEN PIECE AFTER IT WAS INSERTED INTO THE PATIENT'S EYE. THE BROKEN PIECE WAS REMOVED INTRAOPERATIVELY BUT THE IOL REMAINED IN THE PATIENT'S EYE AS IT HAD ENTERED THE MIDDLE OF THE VITREOUS CAVITY. THERE WAS NO DELAY IN TREATMENT OR FURTHER INTERVENTIONS REPORTED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14152403 ↗
• InjuryApr 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CAPSULE OF THE PATIENT'S LEFT EYE (OS) WAS TORN, AND THE PRODUCT HAD PATIENT CONTACT. THE LENS WAS REMOVED AND A REPLACEMENT LENS OF MODEL AR40E, 23.0 DIOPTER WAS USED. THERE WAS NO ADDITIONAL SURGICAL/MEDICAL INTERVENTION REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 14054739 ↗
• MalfunctionJun 17, 2021Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT IOL WAS UNABLE TO DELIVER PROPERLY. THE PATIENT UNDERWENT CATARACT SURGERY IN THE RIGHT EYE AND PHYSICIAN FOUND THAT THE POSTERIOR LOOP (HAPTIC) OF THE INTRAOCULAR LENS WAS CLAMPED WHEN INJECTING THE INTRAOCULAR LENS INTO THE EYE. HENCE, THE INJECTION COULD NOT BE PERFORMED NORMALLY. THE INTRAOCULAR LENS WAS PUSHED WITH A MICRO-TEMPORAL IMPLANT TO ASSIST THE LENS TO BE IMPLANTED INTO THE CAPSULAR BAG. THE INTRAOCULAR LENS WAS IN POSITIVE POSITION. THE PATIENT'S EYE CONDITION WAS NORMAL. NO INDICATION THAT THE IOL WAS REMOVED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12020574 ↗
• InjuryApr 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TECNIS MONOFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S EYE, THE SURGEON NOTICED A TEAR IN THE CAPSULE BAG. THE LENS WAS REMOVED AND REPLACED WITH A MODEL ZA9003 IOL DURING THE SAME PROCEDURE. NO ADDITIONAL SURGICAL INTERVENTION REQUIRED. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE. REPORTEDLY, THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 11714690 ↗
• InjuryApr 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECEIVED REPORT INDICATING THAT AFTER THE INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT¿S OPERATIVE EYE IT DROPPED TO THE BACK OF THE CAPSULAR BAG. THE IOL HAD TO BE CUT OUT AND NO IOL WAS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 11661153 ↗
• InjuryJan 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT DEVELOPED POST-OP INFECTION AFTER INTRAOCULAR LENS (IOL) IMPLANTATION. FURTHER FOLLOW-UP STATED THAT THE CUSTOMER ¿S FACILITY HAS A TOXIC ANTERIOR SEGMENT SYNDROME (TASS) OUTBREAK AND A THOROUGH INVESTIGATION IS BEING DONE BUT A KNOWN CAUSE HAS NOT YET BEEN CONFIRMED. HOWEVER, IT WAS STATED THAT STEROID DROPS WERE GIVEN TO THE PATIENT AS MEDICAL INTERVENTION. THE PATIENT FULLY RECOVERED WITH THE IOL REMAINING IMPLANTED. NO PRODUCT WILL BE RETURNED FOR EVALUATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 11206423 ↗
• InjuryNov 20, 2020Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT THE PATIENT HAD A BROKEN SAC (CAPSULAR BAG) WITH AN INTRAOCULAR LENS (IOL) AS IT WAS PARTIALLY INSERTED. ANOTHER JOHNSON & JOHNSON LENS (DIFFERENT MODEL, ZA9003 AND LOWER DIOPTER 24.0) WAS IMPLANTED AS A REPLACEMENT. THE OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH DAILY ACTIVITIES. THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 10873196 ↗
• InjurySep 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED INTRAOCULAR LENS (IOL) WAS IN THE INJECTOR AND IN EYE BUT IT WAS DECIDED AT LAST MINUTE TO USE ANTERIOR CHAMBER (AC) LENS AS THE BAG WAS BROKEN AND VITRECTOMY WAS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; Vitrectomy

  MAUDE report 10551558 ↗
• InjuryJan 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LENS WAS EXPLANTED FROM PATIENT¿S LEFT EYE IN SECONDARY SURGICAL PROCEDURE. THERE WAS NO INCISION ENLARGEMENT, NO SUTURES AND NO VITRECTOMY PERFORMED. ANOTHER LENS WITH DIFFERENT MODEL ZCU300 24.0 DIOPTER WAS USED AS REPLACEMENT LENS FOR THE PATIENT. PATIENT HAD NO COMPLICATIONS AT DISCHARGE. IT WAS INDICATED THAT LENS WAS NOT BEING RETURNED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9624326 ↗
• InjuryDec 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT'S LEFT EYE AND REMOVED DURING THE SAME-DAY PROCEDURE AS THE CAPSULE BAG TORE DURING INSERTION OF THE LENS. A VITRECTOMY WAS REQUIRED, HOWEVER, THERE WAS NO OTHER COMPLICATIONS. THE SURGERY WAS COMPLETED SUCCESSFULLY USING A NON-JOHNSON & JOHNSON REPLACEMENT LENS. THE PATIENT IS DOING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Capsular Bag Tear; Vitrectomy

  MAUDE report 9522275 ↗
• InjuryAug 30, 2019Failure to Eject; Failure to Eject

  THE CUSTOMER REPORTED THAT INTRAOCULAR LENS (IOL), MODEL ZCB00 24.5 DIOPTER GOT STUCK IN THE CARTRIDGE. IT WAS NOT POSSIBLE TO POSITION/PLACE THE LENS INTO THE EYE DURING THE SURGERY, RESULTING IN ABOUT ONE (1) HOUR DELAY IN THE PROCEDURE IN WHICH THE PATIENT HAD TO WAIT FOR THE NEW LENS TO BE RECEIVED BY THE SURGERY CENTER. AT THE TIME OF THIS EVENT THE PATIENT WAS ON THE TABLE UNDER SEDATION AND BEING MONITORED BY THE ANESTHETIST. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 8952654 ↗
• InjuryAug 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCB00 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT RIGHT EYE DUE TO ANISOMETROPIA (UNEQUAL REFRACTION POWER). IT WAS STATED THAT THERE WAS ALSO INCISION ENLARGEMENT. THE EXPLANTED IOL WAS REPLACED WITH A NON-JOHNSON AND JOHNSON IOL. FOLLOW-UP CONFIRMED THAT THERE WAS NO PATIENT POST-OP INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8909003 ↗
• InjuryJul 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ZCB00 INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED INTO THE PATIENTS OPERATIVE EYE. THE LENS WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. A VITRECTOMY WAS PERFORMED AND AN ANTERIOR CHAMBER LENS WAS PLACED. THE OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE AND THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vitrectomy

  MAUDE report 8840067 ↗
• MalfunctionApr 4, 2019Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT THE HAPTIC OF AN INTRAOCULAR LENS DID NOT UNFOLD WHEN INSERTING INTO THE EYE. THEREFORE, THE LENS WAS REMOVED AND REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8481459 ↗
• InjuryDec 26, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT TECNIS MONOFOCAL INTRAOCULAR LENS (MODEL ZCB00 24.5 DIOPTER) WAS EXPLANTED FROM PATIENT¿S OPERATIVE EYE BECAUSE OF PATIENT EXPERIENCING UNEXPECTED POSTOP REFRACTION. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. LENS WITH SAME MODEL AND SMALLER DIOPTER WAS USED AS REPLACEMENT FOR THE PATIENT. PATIENT WAS DOING WELL. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8196822 ↗
• MalfunctionDec 4, 2018Break; Break

  IT WAS INITIALLY REPORTED THAT A ZCB00, 24.5 DIOPTER INTRAOCULAR LENS (IOL) HAPTIC WAS BROKEN. THROUGH FOLLOW ADDITIONAL INFORMATION WAS PROVIDED, IT LEARNT THAT ONE OF THE HAPTICS WAS FOUND TO BE TORN AT THE DISTAL POINT OF THE ARM UPON OPENING THE PACKAGE. THE LENS WAS NEVER LOADED INTO THE CARTRIDGE AND THERE WAS NO PATIENT CONTACT. THE LENS WAS DISCARDED BY THE SURGERY CENTER. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8131595 ↗
• InjuryAug 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (MODEL ZCB00 +24.5 DIOPTER) WAS IMPLANTED INTO THE PATIENT'S OPERATIVE EYE. REPORTEDLY, THE SURGEON IS PLANNING TO EXPLANT THE LENS AS THE PATIENT POST-OP REFRACTION IS -3.0 DIOPTER. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE SURGEON HAS DONE ALL THE TESTS WHICH MAKE HIM BELIEVE THAT THE IOL POWER IS DIFFERENT FROM THE LABELING BY 3 DIOPTERS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7783474 ↗