TECNIS IOL ZCB00 (REF ZCB0000205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 92 adverse event reports that list this exact device (DI 05050474531727), received between Jan 19, 2017 and May 26, 2026 — classified as 44 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Break” (18 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 92 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A STANDALONE INTRAOCULAR LENS (IOL) EXPERIENCED SUBLUXATION OF THE POSTERIOR CHAMBER LENS, RESULTING IN TEMPORARY LOSS OF VISION. THE PATIENT IS BEING MONITORED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 25294471 ↗
• MalfunctionApr 29, 2026Material Opacification

  IT WAS REPORTED THAT THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL ZCB00, APPEARED TO HAVE A WHITE SPOT ON THE OPTIC. THE LENS WAS NOT IMPLANTED; A BACKUP LENS WAS USED TO COMPLETE THE PROCEDURE. THE COMPLAINT DEVICE WAS DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25024835 ↗
• MalfunctionJan 22, 2026Contamination

  IT WAS REPORTED THERE WAS A SUBSTANCE SUSPECTED OF HAIR FOUND INSIDE THE PACKAGE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24146076 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SUDDEN SURGE OF THE INTRAOCULAR LENS (IOL) OCCURRED DURING IMPLANTATION, CAUSING A POSTERIOR CAPSULAR TEAR. THE IOL WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. AN UNPLANNED VITRECTOMY AND INCISION ENLARGEMENT WERE REPORTED. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT BELONGS TO INTRAOCULAR LENS. ANOTHER REPORT IS SUBMITTED FOR CARTRIDGE.

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

  MAUDE report 23751014 ↗
• MalfunctionNov 11, 2025Break; Break

  IT WAS REPORTED THAT THERE IS A BROKEN LINE NOTICED ON THE INTRAOCULAR LENS (IOL) AFTER IMPLANTATION. IOL WAS REMOVED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23528306 ↗
• InjuryJul 1, 2025Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  THE ZCB00 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). DURING POST-EXAMINATION, A DEFECTIVE LENS WAS OBSERVED FOLLOWING AN ANTERIOR VITRECTOMY FOR POSTERIOR SUBLUXATION. THE IOL WAS EXPLANTED AND REPLACED WITH A NON-JOHNSON & JOHNSON IOL, ALCON MA60AC. THERE WAS NO INCISION ENLARGEMENT, NO PATIENT INJURY, AND NO SUTURES. PATIENT PROGNOSIS POST-PROCEDURE 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 22376729 ↗
• MalfunctionMay 23, 2025Break; Break

  IT WAS REPORTED BY THE SURGEON THAT THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) MOVED FORWARD MORE TIGHTLY THAN USUAL WHILE BEING LOADED. DURING THE IMPLANTATION PROCESS, A SUDDEN JERK OCCURRED, LEADING TO A MINOR CRACK IN THE LENS AND CAUSING PAIN AT THE IMPLANTATION SITE. DESPITE THIS, THE LENS WAS SUCCESSFULLY IMPLANTED IN THE PATIENT'S EYE, AND THE PATIENT IS CURRENTLY STABLE. THE ISSUE WAS NOTED DURING THE INSERTION OF THE LENS INTO THE EYE WHEN THE CARTRIDGE TIP CAME INTO CONTACT WITH THE EYE. UPON FOLLOW-UP, IT WAS STATED THAT THERE WAS NO USER ERROR AND THE PATIENT IS BETTER NOW. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Discomfort

  MAUDE report 22079123 ↗
• InjuryMar 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 IMPLANTED IN THE PATIENT¿S RIGHT EYE. THE IOL WAS EXPLANTED DUE TO THE PATIENT EXPERIENCING VISUAL DISTURBANCES BLURRED VISION. FOLLOW-UP WAS PERFORMED BUT NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 21712432 ↗
• InjuryJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE NON-PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO REFRACTIVE SURPRISE. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH A NON JNJ LENS. THERE WAS NO PATIENT INJURY. THERE WAS MEDICAL/SURGICAL INTERVENTION REQUIRED.

  Patient problems: Visual Impairment

  MAUDE report 21085976 ↗
• MalfunctionNov 12, 2024Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DEFECTIVE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20668104 ↗
• InjuryJul 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE NON PRELOADED INTRAOCULAR LENS (IOL) WAS DESTROYED DURING THE CASE AS THE CAPSULAR BAG HAD BEEN COMPRISED DURING INSERTION. THE LENS WAS CHANGED TO SEW IN LENS FROM ANOTHER MANUFACTURER. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT THE LENS WAS FULLY INSERTED. IT WAS NOT A LENS ISSUE. NO OTHER INFORMATION WAS AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 19801097 ↗
• InjuryMay 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE NON PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S LEFT EYE IN A SECONDARY PROCEDURE AS THE PATIENT HAD CHANGED MIND. THE EXPLANTED LENS WAS REPLACED WITH THE SAME MODEL LENS WITH 2.25 DIOPTER. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. THE PATIENT HAD FULLY RECOVERED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 19388833 ↗
• InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AFTER THE ZCB00 MODEL INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT'S OPERATIVE EYE, A CAPSULE TEAR WAS OBSERVED. THE IOL WAS REMOVED AND EXCHANGED FOR AN AR40 IOL. THE WOUND WAS CLEARED OF VITREOUS AND MIOSTAT WAS INSTILLED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 19327214 ↗
• MalfunctionApr 10, 2024Break; Break

  IT WAS REPORTED THAT HAPTIC BROKE AFTER IMPLANTATION INTO THE EYE. IOL WAS REMOVED AND INCISION WAS ENLARGED. THERE WAS A DELAY TO THE PROCEDURE. REPORTEDLY VISION PRE-OPERATIVE WAS (B)(6). NO FURTHER INFORMATION AVAILABLE.

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

  MAUDE report 19085638 ↗
• MalfunctionJun 6, 2023Contamination; Contamination

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) IMPLANTED AND REMOVED DURING THE SAME PROCEDURE. THAT WHEN THE LENS INSERTED INTO PATIENT¿S RIGHT EYE A DOT/PROTEIN WAS NOTICED ON THE LENS WHICH THE DOCTOR TRIED TO IRRIGATE WITH SALINE AND COULD NOT BE REMOVED. THE CUSTOMER STATED THAT THE LENS INSPECTED PRIOR TO LOADING INTO THE CARTRIDGE AND THE SPOT WAS NOTICED AS IT WAS BEING INSERTED, SO THE PHYSICIAN DECIDED TO REMOVE THE LENS. ANOTHER JOHNSON & JOHNSON LENS WITH THE SAME MODEL AND DIOPTER WAS USED AS A REPLACEMENT. THE ISSUE DID NOT INTERFERE WITH DAILY ACTIVITIES OF THE PATIENT AND NO VISUAL IMPACT ISSUES REPORTED. THERE WERE NO MEDICAL OR SURGICAL INTERVENTIONS REQUIRED OR PLANNED. THE PATIENT IS FINE, AND NO INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17074698 ↗
• InjuryMay 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR HAD TO CHOOSE A DIFFERENT INTRAOCULAR LENS (IOL) AS VITRECTOMY WAS REQUIRED FOR THE PATIENT'S RIGHT EYE. IT WAS STATED THAT EVENT OCCURRED AFTER INSERTION. IT WAS LEARNED THAT THE CAPSULAR BAG BROKE BECAUSE OF A DENSE LENS. THE ACCOUNT INDICATED THAT THERE WAS NO PRODUCT QUALITY ISSUE AND PATIENT IS DOING WELL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A ZA9003, 19.0 DIOPTER AS A REPLACEMENT LENS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 17008334 ↗
• MalfunctionMay 9, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THAT A FULLY INSERTED INTRAOCULAR LENS (IOL) IN A PATIENT¿S LEFT EYE WAS REMOVED AND REPLACED IN THE SAME PROCEDURE DUE TO LENS BEING SCRATCHED. THE ISSUE WAS NOTICED AFTER THE IOL WAS INSERTED. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. A REPLACEMENT LENS OF THE SAME MODEL AND DIOPTER WAS USED. THERE WAS NO INJURY AND THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16899912 ↗
• InjuryJan 11, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) OPTIC HAD A CARVING DESCRIBED AS A SICKLE IN THE CENTER. THE SURGERY WAS COMPLETED BUT THE PATIENT WAS NOT SATISFIED WITH THEIR VISION. THE SURGEON EXPLANTED THE IOL AND REPLACED WITH ANOTHER LENS. THE IOL EXCHANGE SURGERY WENT WELL WITH VISUAL IMPROVEMENT RESULTS AS EXPECTED. THE PATIENT HAS FULLY RECOVERED. THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS REPORTED. THE IOL IS NOT RETURNING FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort

  MAUDE report 16142009 ↗
• MalfunctionSep 15, 2022Material Opacification; Material Opacification

  THE ACCOUNT INITIALLY REPORTED THAT THERE WAS AN IMPERFECTION, DEBRIS MARKING ON THE INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION RECEIVED FROM THE ACCOUNT INDICATED THAT DEPOSITS WERE NOTED ON THE LENS WHILE INSERTING IT INTO THE RIGHT EYE (OD) OF A PATIENT. THE IOL WAS REMOVED AND REPLACED IN THE SAME PROCEDURE. THE REPLACEMENT LENS WAS OF THE SAME MODEL AND DIOPTER. THERE WAS NO CARTRIDGE TIP DAMAGE AND REPORTEDLY THE ISSUE WAS NOT DUE TO USE ERROR. THERE WAS NO REPORTED PATIENT INJURY REPORTED. NO INCISION ENLARGEMENT, VITRECTOMY, AND/OR SUTURES WERE REQUIRED. THE PATIENT IS DOING WELL POST-OPERATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15424984 ↗
• InjurySep 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DYSPHOTOPISA IN THEIR LEFT EYE (OS) RESULTING IN THE NEED FOR AN EXPLANT OF THE INTRA-OCULAR LENS (IOL). THE IOL WAS EXCHANGED FOR A NON-JOHNSON AND JOHNSON MODEL. THERE WAS NO REPORTED PATIENT INJURY. THE IOL WILL NOT BE RETURNED FOR INVESTIGATION AS IT WAS DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 15375412 ↗
• MalfunctionJul 13, 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 A BROKEN SEAL. THERE WAS NO PATIENT CONTACT WITH THE PRODUCT. FOLLOW-UP WAS PERFORMED AND THERE WAS NO ADDITIONAL INFORMATION RECEIVED ABOUT WHERE THE SEAL WAS BROKEN (IF IT WAS THE UNIT CARTON STICKER SEAL OR IF IT WAS THE INNER POUCH SEAL). NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15008531 ↗
• MalfunctionJul 6, 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 A BROKEN SEAL. THERE WAS NO PATIENT CONTACT WITH THE PRODUCT. NO FURTHER DETAILS COULD BE OBTAINED UPON FOLLOW-UPS WITH THE ACCOUNT AS CUSTOMER COULD NOT PROVIDE WHERE THE SEAL WAS BROKEN (IF IT WAS THE UNIT CARTON STICKER SEAL OR IF IT WAS THE INNER POUCH). NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14939913 ↗
• MalfunctionJun 3, 2022Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO PATIENT'S RIGHT EYE, HOWEVER, WAS REMOVED DURING THE SAME PROCEDURE AS THE LENS WAS SCRATCHED. ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT. THE PATIENT HAS RECOVERED. NO OTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14599068 ↗
• MalfunctionFeb 17, 2022Break; Break

  IT WAS REPORTED THAT THE BACK HAPTIC TORE WITH AN INTRAOCULAR LENS (IOL) WHILE BEING IMPLANTED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13553305 ↗
• MalfunctionFeb 17, 2022Break; Scratched Material; Material Split, Cut or Torn; Break; Scratched Material; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO PATIENT'S RIGHT EYE, HOWEVER, THE LENS WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE AS THE LENS WAS SCRATCHED, WAS CRACKED, AND HAD A TORN IOL. THE ORIGINAL LENS WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13553177 ↗