TECNIS IOL ZCB00 (REF ZCB0000235)Recalls & reported problems

Summary

The FDA's MAUDE database contains 91 adverse event reports that list this exact device (DI 05050474531789), received between Aug 22, 2016 and Aug 11, 2026 — classified as 42 injuries, 49 malfunctions.

The most frequently reported specific device problem is “Break” (19 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 91 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50203081 ↗
• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S OPERATIVE EYE. NO ADDITIONAL INFORMATION REGARDING THE REASON FOR THE EXPLANTATION OR THE PATIENT OUTCOME WAS PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 24913275 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  A SINGLE-PIECE, NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS REPORTED TO HAVE BEEN EXPLANTED FROM THE PATIENT'S LEFT EYE. THE ISSUE WAS IDENTIFIED FOLLOWING IMPLANTATION. NO ADDITIONAL DETAILS REGARDING THE CIRCUMSTANCES OF THE EXPLANT OR THE PATIENT¿S POST-OPERATIVE CONDITION WERE PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 24531726 ↗
• InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem

  THE ZCB00 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). IN A SECONDARY SURGICAL PROCEDURE, THE IOL WAS EXPLANTED DUE TO COMPLAINTS OF REFRACTIVE ERROR AND REPLACED WITH A ZCB00 22.0 IOL. PATIENT PROGNOSIS POST LENS EXCHANGE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 24285126 ↗
• InjuryJan 5, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT WHEN THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED, THE HAPTICS DID NOT UNFOLD, AND WHEN MORE BALANCED SALT SOLUTION (BSS) WAS ADDED, THE LENS ROTATED ABRUPTLY AND RUPTURED THE POSTERIOR CAPSULE. THEREFORE, THE LENS WAS EXPLANTED AND REPLACED WITH THREE-PIECE JOHNSON AND JOHNSON IOL. THERE WAS A 15 MINUTE DELAY IN THE PROCEDURE. NO SECONDARY SURGERY OR MEDICAL INTERVENTION WAS REQUIRED, SUCH AS INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES. THE PATIENT STATUS IS UNKNOWN. THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 23970559 ↗
• InjuryDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ZCB00 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). POST-OPERATIVELY, THE PATIENT WAS HAVING DIFFICULTY WITH DEPTH PERCEPTION AND OVERALL VISION, SPECIFICALLY WHILE DRIVING. THUS THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE. REPLACEMENT LENS INFORMATION WAS NOT PROVIDED. PATIENT PROGNOSIS POST LENS EXCHANGE IS ALSO UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 23888862 ↗
• MalfunctionDec 15, 2025Material Opacification; Material Opacification

  IT WAS REPORTED THAT A FOREIGN BODY OR DEPOSIT WAS DISCOVERED ON THE LENS OPTIC AFTER IMPLANTATION OF THE INTRAOCULAR LENS (IOL). THE PATIENT IS WITHOUT IMPAIRMENT. MEDICATIONS DISPADEX COMP AND GLAUPAX WERE PRESCRIBED. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23812465 ↗
• InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS BOOKED FOR A COMBINED CATARACT EXTRACTION AND IOL IMPLANT AND POSTERIOR VITRECTOMY. THE CASE STARTED BY PERFORMING THE CAT EXTRACTION AND IOL IMPLANT WHERE DOCTOR PUT IN THE J&J LENS SUCCESSFULLY. ON PROCEEDING INTO THE RETINA HOWEVER, IT WAS DETERMINED THAT THE PATIENT HAD A RETINAL COLLAPSE AND THE DOCTOR COULD PROCEED NO FURTHER. DOCTOR DECIDED THAT IT WAS BETTER TO REMOVE THE IMPLANTED LENS AS THERE WAS NO NEED FOR IT DUE TO THE COLLAPSED RETINA.

  Patient problems: Retinal Detachment

  MAUDE report 22926022 ↗
• MalfunctionNov 7, 2024Break; Break

  IT WAS REPORTED THAT THE MONOFOCAL INTRAOCULAR LENS (IOL) WAS DEFECTIVE. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20626326 ↗
• InjuryOct 18, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT HAD COMPLAINED OF POOR VISION SINCE THE IMPLANTATION OF AN INTRAOCULAR LENS (IOL). IT WAS REPORTED THAT THE PATIENT'S VISION WAS INCREASINGLY GETTING WORSE AND THAT THE ISSUES WITH SIGHT WERE VERY CHANGEABLE, SOMETIMES MORE, SOMETIMES LESS. FURTHER EVALUATION DETECTED AN ABNORMALITY OF THE IOL (A CENTRALLY EMPHASIZED VEIL ON THE IOL). IT WAS REPORTED THAT THE CHANGE IN THE IOL IS NOT VERY PRONOUNCED. ANALYSIS OF THE EYE REVEALED THAT THE PATIENT HAS DRY MACULAR DEGENERATION AND THE VISION GETTING WORSE COULD BE LINKED TO THE MACULA DEGENERATION INCREASING. THEREFORE, THE SURGEON EXPLANTED THE IOL. THE LENS WAS CUT INTO MANY PIECES AND IS NOT AVAILABLE FOR EVALUATION. THE PATIENT WAS SUCCESSFULLY IMPLANTED WITH A DIFFERENT LENS OF THE SAME DIOPTER AND IS VERY SATISFIED. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20487472 ↗
• InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE PATIENT IMPLANTED WITH A NON-PRELOADED INTRAOCULAR LENS (IOL) COMPLAINED OF NOT SEEING PROPERLY AND WAS NOT HAPPY WITH THE RESULT. UPON FOLLOW-UP, IT WAS NOTED THAT THE PATIENT IS EXPERIENCING DEBILITATING CONDITIONS AND CANNOT PERFORM MORE THAN ONE ACTIVITY. THERE WAS NO REQUIREMENT OF MEDICAL OR SURGICAL INTERVENTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 20092395 ↗
• MalfunctionAug 22, 2024Break; Break

  IT WAS REPORTED, THAT SEVERAL MONOFOCAL INTRAOCULAR LENSES (IOLS) WERE DEFECTIVE. IT WAS UNKNOWN, IF THERE WAS PATIENT CONTACT OR NOT. NO OTHER INFORMATION WAS PROVIDED. THIS MDR REPORT PERTAINS TO THE SUSPECT IOL MODEL: ZCB00, SERIAL NUMBER#: (B)(6). A SEPARATE REPORT WILL BE SUBMITTED FOR THE OTHER 5 SUSPECT IOLS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20032751 ↗
• MalfunctionMay 1, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT WHEN THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE LEFT EYE, IT DID NOT SEAT CORRECTLY. THE LENS WAS CUT OUT AND ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED (ZA9003, 23.0 DIOPTER). SUTURES WERE PLACED. THE PATIENT HAD NO AVERSE EFFECTS AND THERE WAS NO PATIENT INJURY. THE PATIENT IS DOING WELL POST-OPERATIVE. THE LENS WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19226853 ↗
• MalfunctionApr 25, 2024Material Discolored; Material Opacification; Material Discolored; Material Opacification

  IT WAS REPORTED THAT DURING THE POST OPERATIVE FOLLOW-UP THE PHYSICIAN FOUND THAT THE INTRAOCULAR LENS (IOL) WAS OPACIFIED AND ITS COLOR HAS CHANGED FROM THE CENTER. END USER HAS NOT USED THE PRODUCT BEFORE. NO MEDICAL INTERVENTIONS WERE MENTIONED. THROUGH FOLLOW-UP WE LEARNED THAT THE ISSUE WAS NOTICED IN A FOLLOW-UP VISIT IN THE YEAR 2023. PATIENT WAS FACING IMPAIRMENT; HOWEVER, AFTER EXPLANT THE PATIENT WAS FINE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19188375 ↗
• MalfunctionApr 11, 2024Break; Break

  IT WAS REPORTED THAT THE ONE OF THE HAPTICS OF THE NON-PRELOADED INTRAOCULAR LENS (IOL) WAS DAMAGED. IT IS NOTED THAT THERE WAS NO PATIENT INVOLVEMENT, BUT IT IS UNKNOWN IF THE PRODUCT WAS IN CONTACT WITH THE PATIENT. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19092779 ↗
• MalfunctionJan 23, 2024Break; Ejection Problem; Break; Ejection Problem

  IT WAS REPORTED THAT THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS A "BAD LOAD". THROUGH FOLLOW-UP, IT WAS LEARNED THAT "BAD LOAD" MEANT "POOR FLEXIBILITY OF THE LOAD" OR "POOR FLEXIBILITY OF THE LENS". THE ISSUE WAS NOT DUE TO USE ERROR. THE LENS WAS PARTIALLY INSERTED IN THE LEFT EYE. THERE WAS NO PATIENT INJURY. NO MEDICAL OR SURGICAL INTERVENTION OR ADDITIONAL SURGICAL MANEUVERS WERE REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACK-UP LENS (SAME MODEL AND DIOPTER). BALANCE SALT SOLUTION (BSS) WAS USED AT ROOM TEMPERATURE. AFTER THE INSERTER WAS PREPPED, THERE WAS NO DELAY IN SURGERY BEFORE ADVANCING THE LENS. IT WAS NOTED THAT THE LENS "MOVED A LITTLE" WHEN TRYING TO ADVANCE. THE PRODUCT IS NOT AVAILABLE TO BE RETURNED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18566723 ↗
• MalfunctionJan 19, 2024Break; Break

  IT WAS REPORTED THAT THE NON PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT LEFT EYE DURING SAME PROCEDURE DUE TO HAPTIC BROKEN. DIRECTIONS FOR USE WERE FOLLOWED. THERE WAS NO INCISION ENLARGEMENT, NO SUTURES AND VITRECTOMY WAS NOT REQUIRED. THE LENS WAS REPLACED WITH SAME J&J MODEL AND DIOPTER LENS. PRODUCT IS BEING RETUNED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18544792 ↗
• InjuryOct 13, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THE ZCB00 MODEL INTRAOCULAR LENS (IOL) EXPLANTED FROM THE PATIENT'S EYE THE DAY OF SURGERY AND REPLACED WITH AN ALCON MA60AC DUE TO COMPLICATIONS DURING SURGERY; WHAT COMPLICATIONS OCCURRED IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 17928343 ↗
• InjuryJun 23, 2023Adverse 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 INSERTED INTO THE PATIENT'S LEFT EYE. THE PATIENT EXPERIENCED A CAPSULE TEAR WHICH REQUIRED THE IOL TO BE REMOVED AND REPLACED WITH A JNJ 3-PIECE LENS IN THE SAME PROCEDURE. THE PATIENT OUTCOME WAS REPORTED AS ¿GOOD¿. NO FURTHER SURGICAL OR MEDICAL INTERVENTIONS WERE REPORTED. THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 17195431 ↗
• MalfunctionFeb 2, 2023Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD A BENT/BROKEN HAPTIC. THE LENS WAS FULLY INSERTED IN THE PATIENT'S LEFT EYE AND REMOVED DURING THE SAME PROCEDURE. ANOTHER JOHNSON & JOHNSON LENS, MODEL ZA9003 23.5 DIOPTER WAS IMPLANTED AS A REPLACEMENT. THE OUTCOME DID NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16286953 ↗
• MalfunctionSep 13, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DAMAGED AND IT WAS NOT IMPLANTED INTO PATIENT'S OPERATIVE EYE. IT WAS ALSO REPORTED IT WAS UNKNOWN IF THERE WAS PATIENT CONTACT AND THERE WAS NO PATIENT INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15415326 ↗
• MalfunctionJul 14, 2022Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem; Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) ARRIVED WITH BROKEN SEAL. THERE WAS NO PATIENT CONTACT. FOLLOW-UP WAS PERFORMED AND THERE WAS NO INFORMATION ABOUT THE CARTON STICKER SEAL OR THE INNER POUCH THAT WAS BROKEN. NO FURTHER INFORMATION IS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15010033 ↗
• InjuryMay 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S LEFT EYE DUE TO NEGATIVE DYSPHOTOPSIA FROM IOL, LENS EDGE AFFECTING PERIPHERAL VISION. A NON-JOHNSON & JOHNSON LENS WAS USED AS THE REPLACEMENT. THERE WAS NO PATIENT INJURY REPORTED. THERE HAS BEEN NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION REQUIRED AT THIS TIME, AND THERE ARE NO REPORTED PRE-EXISTING MEDICAL CONDITIONS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 14350572 ↗
• MalfunctionApr 11, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING THE POST-OPERATIVE EXAMINATION, FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION, IT WAS DISCOVERED THAT BIOMETRICS WERE INCORRECT BY 4 DIOPTERS. THE SURGEON CHECKED ALL PRE-OPERATIVE VALUES AND ALL CALCULATIONS WERE CORRECT. THE IOL WAS EXPLANTED AND REPLACED WITH THE SAME LENS TYPE WITH THE SAME DIOPTER POWER. THE IOL WAS DISCARDED UPON REMOVAL. NO ADDITIONAL ISSUES WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 14079504 ↗
• MalfunctionOct 26, 2021Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT A ZCB00 MODEL INTRAOCULAR LENS(IOL) WAS IMPLANTED AND HAD A CRACKED HAPTIC AND OPTIC. THE LENS WAS CUT OUT AND WAS REPLACED BY ANOTHER ZCB00 LENS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12699389 ↗