TECNIS IOL ZCB00 (REF ZCB0000220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 103 adverse event reports that list this exact device (DI 05050474531758), received between Nov 2, 2016 and Aug 25, 2026 — classified as 58 injuries, 45 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 103 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50440077 ↗
• InjuryFeb 19, 2026Break

  IT WAS REPORTED THAT DURING IMPLANTATION OF A TECNIS INTRAOCULAR LENS, A HAPTIC FRACTURED DURING INSERTION. THE LENS BECAME UNSTABLE AND WAS EXPLANTED DURING THE SAME PROCEDURE. POSTOPERATIVELY, THE PATIENT EXPERIENCED TEMPORARY VISUAL IMPAIRMENT WITH VISUAL ACUITY REDUCED TO HAND MOVEMENTS, SIGNIFICANTLY AFFECTING DAILY ACTIVITIES. THE INCISION WAS ENLARGED, ADDITIONAL SUTURES WERE PLACED, AND A VITRECTOMY WAS REQUIRED. A SECONDARY ANTERIOR-CHAMBER INTRAOCULAR LENS IMPLANTATION IS PLANNED FOR A LATER DATE. ADDITIONAL INFORMATION REVEALED THAT NO MEDICATIONS BEYOND THE STANDARD PRESCRIBED REGIMEN WERE ADMINISTERED. THE PATIENT REMAINS APHAKIC AND THE CURRENT STATUS IS UNKNOWN. 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 24393760 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S LEFT EYE IN A SECONDARY SURGICAL PROCEDURE DUE TO THE PATIENT EXPERIENCING POOR VISION. A DIFFERENT, NON¿JOHNSON & JOHNSON IOL WAS IMPLANTED AS THE REPLACEMENT. THE PATIENT¿S POSTOPERATIVE OUTCOME WAS REPORTED AS GOOD; NO INJURY OCCURRED AND NO FURTHER SURGICAL OR MEDICAL INTERVENTIONS WERE REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 23751542 ↗
• MalfunctionAug 25, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS WAS IMPLANTED INTO THE LEFT EYE OF A FEMALE PATIENT. DURING THE PROCEDURE, THE SURGEON WAS UNABLE TO CENTER THE LENS, WHICH LED TO ITS EXPLANTATION AND REPLACEMENT WITH ANOTHER LENS OF THE SAME MODEL AND DIOPTER. THE SURGERY WAS COMPLETED ON THE SAME DAY WITHOUT CAUSING HARM TO THE PATIENT, AND THE WOUND DID NOT REQUIRE ENLARGEMENT OR SUTURES. THE PLATINUM HANDPIECE AND CARTRIDGE WERE USED, AND THE LENS WAS LOADED WITH ROOM TEMPERATURE AMVISC, REMAINING IN THE VISCOELASTIC FOR LESS THAN THREE MINUTES. NO PHOTOS OR VIDEOS OF THE EVENT WERE AVAILABLE. THE DEFECTIVE LENS AND CARTRIDGE WERE AVAILABLE FOR RETURN, AND NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22891813 ↗
• MalfunctionJun 16, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO THE PATIENT'S RIGHT EYE AND REMOVED AS THE HAPTIC POPPED OFF/DETACHED WHILE IN THE EYE. IT WAS NOTED THAT THE HAPTIC DID NOT SEPARATE IN TWO PIECES. THE PROCEDURE WAS COMPLETED USING A DIFFERENT LENS. IT WAS STATED THAT THE ISSUE WAS NOT DUE TO USE ERROR AND THAT THE CARTRIDGE TIP WAS NOT DAMAGED. THE PATIENT DID NOT SUSTAIN ANY INJURY, AND NO SURGICAL OR MEDICAL INTERVENTIONS, SUCH AS INCISION ENLARGEMENT OR THE ADMINISTRATION OF MEDICATIONS, WERE NECESSARY. THE PATIENT IS DOING FINE. THE PRODUCT WILL NOT BE RETURNED AS IT WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22214230 ↗
• InjuryMay 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE DUE TO THEM EXPERIENCING DYSPHOTOPSIA. THE ISSUE WAS NOTICED DURING A POSTERATIVE-OP EXAM AND THE SYMPTOMS LAST 3 MONTHS. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, SUTURES OR DELAYS. NO MEDICATION OUTSIDE THE STANDARD OF CARE. THE REPLACEMENT IOL IS A NON-JOHNSON AND JOHNSON LENS SOFTEC HDO +20.75. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 22092849 ↗
• MalfunctionMay 15, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) RIPPED WHEN BEING INSERTED INTO THE EYE. FOLLOW-UP WAS PERFORMED BUT THE CUSTOMER WAS UNABLE TO PROVIDE ANY FURTHER DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22032280 ↗
• MalfunctionMay 12, 2025Break; Break

  IT WAS REPORTED THAT AFTER IOL LENS WAS IMPLANTED, IT WAS FOUND CRACKED. LENS WAS REMOVED AND A NEW IOL WAS REPLACED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22006777 ↗
• MalfunctionApr 11, 2025Contamination; Contamination

  IT WAS REPORTED THAT THE SURGEON FOUND SOME FOREIGN MATERIALS INSIDE THE EYE AFTER THE IMPLANTATION OF NON-PRELOADED INTRAOCULAR LENS (IOL), WHICH WAS NOT REMOVED EVEN BY IRRIGATION AND ASPIRATION (I/A) PROCESS. DESPITE THE UNEXPECTED RESULT, THE SURGEON DECIDED NOT TO EXTRACT THE IOL AS THE PATIENT WAS TOO ELDERLY TO GO THROUGH THIS COMPLICATED PROCEDURES. BUT THE SURGEON WANTS TO BE AWARE OF THE POSSIBLE IMPACT THIS MATERIAL INVOLVED COULD HAVE ON THE PATIENT¿S EYE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21830719 ↗
• MalfunctionOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE NON-PRE-LOADED ZCB00 MODEL INTRAOCULAR LENS (IOL) WAS REPORTED TO HAVE BEEN DEFECTIVE AND COULD NOT BE USED. EXTENT OF PATIENT CONTACT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20512124 ↗
• InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BLURRY VISION WAS REPORTED BY THE PATIENT FOLLOWING THE IMPLANTATION OF THE NON-PRE-LOADED ZCB00 MODEL INTRAOCULAR LENS (IOL). THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH ANOTHER J&J IOL, MODEL AND SERIAL NUMBER INFORMATION WAS NOT PROVIDED. DURING THE LENS EXCHANGE PROCEDURE, THERE WAS NO PATIENT INJURY AND NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. PATIENT PROGNOSIS POST-LENS EXCHANGE WAS REPORTED AS DONG FINE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 20512058 ↗
• MalfunctionMay 15, 2024Material Opacification; Material Opacification

  THE CUSTOMER REPORTED THAT THE MONOFOCAL INTRAOCULAR LENS (IOL) HAD A STAIN ON THE OPTICS SO IT COULD NOT BE USED. THERE WAS NO PATIENT CONTACT WITH THE LENS OR CARTRIDGE AS THE ISSUE WAS DURING HANDLING, BUT BEFORE THE INSERTION OF THE LENS INTO THE EYE. THAT A CARTRIDGE WAS NOT USED BECAUSE THE NURSE SAW THE DAMAGE ON THE LENS PRIOR TO LOADING INTO THE CARTRIDGE. IT WAS CONFIRMED THAT A REPLACEMENT LENS OF THE SAME MODEL AND DIOPTER WAS USED. NO MEDICAL INTERVENTION REQUIRED AND THERE WILL BE NO SURGICAL INTERVENTION IN THE FUTURE. AS EXPECTED, THE PATIENT WAS NOT AFFECTED BY THIS ISSUE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19323333 ↗
• InjuryApr 8, 2024Break; Ejection Problem; Break; Ejection Problem

  IT WAS REPORTED THAT THE TRAILING HAPTICS GOT STUCK WITH THE INJECTOR AND SUBSEQUENTLY DAMAGED. LENS WAS PARTIALLY INSERTED INTO THE EYE WHEN THE ISSUE OCCURRED. IOL WAS REMOVED. VISION PRE-OPERATIVE:6/36 AND VISION POST-OPERATIVE:6/36. INCISION WAS ENLARGED AND SUTURED WAS REQUIRED. VITRECTOMY WAS PERFORMED AND MEDICATION WAS PRESCRIBED. THERE WAS DELAY TO THE TREATMENT. NO FURTHER INFORMATION AVAILABLE.

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

  MAUDE report 19060377 ↗
• MalfunctionMar 25, 2024Break; Break

  A REPORT WAS RECEIVED THAT A NON PRELOADED INTRAOCULAR LENS (IOL) WAS DAMAGED. UNKNOWN IF THERE WAS PATIENT CONTACT OR NOT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18975682 ↗
• InjuryOct 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS WAS RECEIVED IN JOHNSON & JOHNSON LAB WITH AN INTAKE FORM INDICATING THAT THE IOL WAS EXPLANTED DUE TO ANISOMETROPIA/DIPLOPIA. IT WAS NOTED THAT EVENT WAS FIRST OBSERVED DURING POST-OP EXAMINATION. THE INCISION WAS SLIGHTLY ENLARGED, BUT NO SUTURES USED, AND NO VITRECTOMY REQUIRED. THERE WAS NO DELAY IN PROCEDURE REPORTED. THE PATIENT OUTCOME WAS NOT PROVIDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 17916180 ↗
• InjuryAug 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD ROUTINE CATARACT SURGERY ON (B)(6) 2023, PHACOEMULSIFICATION WITH INTRAOCULAR LENS (IOL) IMPLANTATION INTO THE PATIENT'S OPERATIVE EYE. POST-OPERATIVE VISUAL ACUITY PROVIDED AS 6/7.5 AND ON THE SUBSEQUENT TWO (2) VISITS READINGS WERE 6/6. ON (B)(6) 2023 PATIENT PRESENTED WITH PAINFUL EYE AND BLURRED VISION. ACCOUNT INDICATED THAT THE PATIENT HAD VISION PERCEPTION TO LIGHT ONLY AND THEY HAD HYPOPYON. AQUEOUS AND VITREOUS TAP WAS DONE. RESULTS WERE AS FOLLOWS: NO GRAM STAIN, ORGANISMS IDENTIFIED, THREE (3) POLYMORPH SEEN. AFTER FIVE (5) DAYS, ALL FOUR (4) CULTURE PLATES HAD NO GROWTH. PATIENT HAD STERILE ENDOPHTHALMITIS POST-OPERATIVELY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Endophthalmitis; Eye Pain; Hypopyon; Loss of Vision

  MAUDE report 17627483 ↗
• InjuryAug 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ZONULYSIS OCCURRED AFTER INTRAOCULAR LENS (IOL) IMPLANTATION INTO THE PATIENT'S OPERATIVE EYE. LENS WAS FULLY INSERTED. ADDITIONAL INFORMATION RECEIVED STATED THAT THE LENS WAS REMOVED DURING SAME PROCEDURE AND REPLACED WITH ANOTHER IOL. THERE WAS NO REPORTED INJURY TO PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Zonular Dehiscence

  MAUDE report 17608475 ↗
• InjuryAug 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CAPSULAR BAG WAS NOT STABLE TO HOLD THE TECNIS SINGLE PIECE MONOFOCAL INTRAOCULAR LENS (IOL) AFTER IMPLANTATION/APPLICATION. LENS WAS FULLY INSERTED. SURGEON REQUESTED TO CHANGE IOL. THERE WERE NO COMPLICATIONS. UPON FURTHER FOLLOW UP IT WAS CONFIRMED THAT THERE WAS NO PRODUCT QUALITY ISSUE. NO INJURY AND PATIENT WAS DOING WELL. THE TECNIS IOL WAS EXPLANTED ON THE SAME DAY AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER IOL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 17576715 ↗
• MalfunctionJul 18, 2023Contamination; Device Difficult to Setup or Prepare; Contamination; Device Difficult to Setup or Prepare

  IT WAS REPORTED WHEN THE DOCTOR WENT TO INJECT THE NON-PRELOADED ZCB00 MODEL INTRAOCULAR LENS (IOL) AND WHEN THE IOL WAS HALFWAY IT "GOT CAUGHT ON SOMETHING" WHICH ALSO PUSHED THE INJECTOR OUT OF THE EYE AS WELL. THE DOCTOR STATED HE MAY HAVE SEEN A SLIVER OF PLASTIC OR SOMETHING IN THE EYE SO HE TOOK OUT THE IOL. BACK-UP ZCB00 22.0 DIOPTER IOL WAS IMPLANTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). IT WAS CONFIRMED THE SUSPECT ZCB00 IOL WAS FULLY INSERTED AND THEN REMOVED. THERE WAS NO PATIENT HARM AND NO MEDICAL INTERVENTIONS WAS REQUIRED. THE FOREIGN MATERIAL IS NOT AVAILABLE FOR ANALYSIS AND PHOTOS ARE NOT AVAILABLE. PATIENT OUTCOME POST-PROCEDURE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17347771 ↗
• InjuryJul 3, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THERE WAS INSTABILITY OF THE INTRAOCULAR LENS (IOL) AFTER IMPLANTATION AND THE LENS WAS REMOVED FROM THE PATIENT'S EYE. A REPLACEMENT IOL WAS INSERTED. THE BEST CORRECTED VISUAL ACUITY PRE-OP WAS (B)(6) AND POST-OP WAS (B)(6) AND COUNTING FINGERS. THE PATIENT WAS TEMPORARILY IMPAIRED. THERE WAS UNPLANNED INCISION ENLARGEMENT, UNPLANNED VITRECTOMY AND UNPLANNED SUTURES. THE PATIENT ALSO RECEIVED MEDICAL INTERVENTION. THERE WAS NO DELAY IN TREATMENT. NO OTHER INTERVENTIONS WERE PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 17253090 ↗
• InjuryJun 20, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS INSERTED AND REMOVED DURING IMPLANTATION INTO THE PATIENT'S EYE. THE CAUSE IS UNKNOWN AND IT IS UNKNOWN IF THERE WAS ANY PATIENT INJURY. SURGERY TIME WAS DELAYED. INCISION WAS ENLARGED AND SUTURES WERE REQUIRED. VITRECTOMY WAS PERFORMED AND MEDICATION WAS PRESCRIBED. SURGERY COMPLETED SUCCESSFULLY WITH PATIENT REPORTED AS FULLY RECOVERED WITH NO IMPACT TO VISION. VISION PRE-OPERATIVE: 3/60 AND VISION POST-OPERATIVE: 6/12. NO FURTHER INFORMATION AVAILABLE.

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

  MAUDE report 17165944 ↗
• MalfunctionJun 6, 2023Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) GOT CRACKED WHEN A TORIC INJECTOR RELEASED THE IOL INTO A PATIENT'S LEFT EYE. IT WAS LEARNED THAT IOL WAS INSERTED IN INSTRUMENT CARTRIDGE AND INJECTED INTO PATIENT'S EYE. THE DOCTOR FOUND THAT IOL WAS CRACKED. ANOTHER INSTRUMENT WAS USED TO CUT THE IOL INTO 2 PIECES AND REMOVE IT FROM PATIENT'S EYE. A NEW IOL WAS OPENED AND LOADED AND PLACED IN PATIENT'S EYE. PATIENT TOLERATED WELL WITHOUT ANY ISSUES. NO TREATMENT INDICATED, NO APPARENT INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17076000 ↗
• InjuryMar 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING INJECTION OF THE IOL (INTRAOCULAR LENS), A TEAR WAS NOTED IN THE POSTERIOR CAPSULE. THEREFORE, THE INCISION WAS ENLARGED TO REMOVE THE IOL. THE REPLACEMENT LENS IS A DIFFERENT MODEL, ZA9003 21.5 DIOPTER. IT'S A 3-PIECE LENS WHICH WAS IMPLANTED IN THE SULCUS. REPORTEDLY, NO SUTURES WERE REQUIRED. NO ADDITIONAL INJURIES WERE REPORTED. THE SUSPECT IOL WILL NOT BE RETURNED AS IT WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 16542462 ↗
• InjuryMar 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS FULLY IMPLANTED AND REMOVED FROM THE PATIENT¿S LEFT EYE AS THE BAG BROKE. THE ISSUE WAS OBSERVED AFTER THE INSERTION OF THE LENS INTO EYE. A VITRECTOMY WAS PERFORMED, AND ANOTHER JOHNSON AND JOHNSON LENS OF DIFFERENT MODEL AND DIOPTER (ZA9003, 21.5) WAS USED AS THE REPLACEMENT LENS. IT WAS INDICATED THAT THERE WAS NO PATIENT INJURY. THE PATIENT OUTCOME WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 16483324 ↗
• MalfunctionSep 6, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED AND REMOVED AND REPLACED IN THE SAME PROCEDURE FROM THE LEFT EYE DUE TO THE LENS HAVING A NICK OR AN IMPERFECTION. AN INCISION ENLARGEMENT WAS REQUIRED. ANOTHER JOHNSON & JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (SAME MODEL AND DIOPTER). THE PATIENT IS FINE. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 15366767 ↗