TECNIS IOL ZCB00 (REF ZCB0000155)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 05050474531628), received between Jun 22, 2017 and Dec 4, 2025 — classified as 9 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryDec 4, 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 SINISTER (LEFT EYE). ON (B)(6) 2024 POSTERIOR CAPSULE OPACIFICATION (PCO) WAS NOTED DURING A YTTRIUM ALUMINUM GARNET (YAG) EVALUATION. THE PATIENT CAN PERFORM HER DAILY ACTIVITIES AS SHE DID PRIOR TO THE SURGICAL PROCEDURE. A YAG LASER CAPSULOTOMY PROCEDURE WAS PERFORMED ON (B)(6) 2024. BEST CORRECTED VISUAL ACUITY (BCVA) PRE-OPERATIVE WAS 30 AND POST-OPERATIVE WAS 20. PATIENT PROGNOSIS WAS REPORTED AS FULLY RECOVERED. THE IOL DIRECTIONS FOR USE WERE FOLLOWED. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT REMAINS IMPLANTED IN THE PATIENT'S EYE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Posterior Capsule Opacification

  MAUDE report 23713199 ↗
• InjuryFeb 24, 2023Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED BUT THERE WAS A CAPSULE TEAR NOTICED AND THE LENS WAS REMOVED AND REPLACED IN THE SAME PROCEDURE. THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 16440596 ↗
• MalfunctionFeb 21, 2023Break; Break

  IT WAS REPORTED TO REPLACE THE INTRAOCULAR LENS (IOL) AND NOT TO BILL. IT IS INDICATED THAT THERE IS A DEFECT/ISSUE. IT IS UNKNOWN IF THERE IS PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16414900 ↗
• InjuryApr 26, 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 WASTED DURING SURGERY. THE BAG TORE AND VITRECTOMY WAS NEEDED. NO FURTHER PATIENT INJURY OCCURRED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 14214967 ↗
• InjuryJul 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCB00 MODEL INTRAOCULAR LENS(IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE DUE TO PATIENT COMPLAINING THAT ORIGINAL TARGET DISTANCE WAS NOT MET. THERE WAS NO PATIENT INJURY. THE REPLACEMENT LENS USED IS A SAME MODEL BUT DIFFERENT DIOPTER LENS. PATIENT WAS DOING GOOD AT THE TIME OF DISCHARGE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 12178539 ↗
• InjuryJul 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT''S RIGHT (OD) EYE DUE TO HYPEROPIA AND BLURRY VISION AT 1-DAY POST-OPERATION. THE PATIENT OUTCOME WAS REPORTED AS 20/25 -.075 SPHERE. THERE WAS NO ADDITIONAL SURGICAL INTERVENTION PERFORMED DURING THE SECONDARY PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 10248922 ↗
• MalfunctionAug 26, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT AFTER THE SURGEON IMPLANTED AN INTRAOCULAR LENS (IOL) MODEL ZCB00 INTO THE PATIENT¿S EYE, A WHITE SPOT WAS FOUND ON THE CENTER OF LENS. THE SURGEON TRIED TO REMOVE THE SPOT BUT WAS UNABLE TO DO SO. THE SURGEON STILL COMPLETED THE SURGERY AND THE PATIENT DOES NOT FEEL ANY DISCOMFORT AS A RESULT OF THE WHITE SPOT. POST-OP VISUAL ACUITY IS NOT AFFECTED BY THE SPOT. THE SURGEON FEELS THAT THE SPOT IS IN THE BODY OF THE LENS, AND MAY TRY TO VERIFY THIS BY SLIT-LAMP EXAM ON THE PATIENT'S NEXT VISIT. THE ACCOUNT STATED THAT THIS IS THE SECOND TIME THIS EVENT HAS OCCURRED; HOWEVER, THEY DID NOT REPORT THE FIRST INCIDENT UNTIL NOW. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS EMDR REPORT PERTAINS TO THE SECOND EVENT. A SEPARATE REPORT WILL BE SUBMITTED FOR THE FIRST EVENT THAT THE ACCOUNT ENCOUNTERED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8932788 ↗
• MalfunctionJan 16, 2019Break; Break

  IT WAS INITIALLY REPORTED THAT A ZCB00 15.5 DIOPTER INTRAOCULAR LENS (IOL) HAPTIC WAS BROKEN. THROUGH FOLLOW UP IT WAS LEARNT THAT WHEN THE TECHNICIAN INSPECTED THE LENS UPON OPENING THE PACKAGE, THE HAPTIC DID NOT LOOK RIGHT. THE LENS WAS NEVER LOADED INTO THE INSERTER. THERE WAS NO PATIENT CONTACT WITH THE LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8255603 ↗
• InjuryOct 19, 2018Scratched Material; Scratched Material

  IT WAS REPORTED WHEN INSERTING ZCB00 15.5 DIOPTER INTRAOCULAR LENS (IOL) INTO THE EYE THE LENS WAS SCRATCHED BY THE INJECTOR UPON INSERTION. THERE WAS INCISION ENLARGEMENT, NO VITRECTOMY, AND A SIMILAR LENS WAS USED TO COMPLETE THE PROCEDURE. ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER ACCOUNT REQUESTING ADDITIONAL INFORMATION HOWEVER, NO RESPONSE WAS RECEIVED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 7987628 ↗
• MalfunctionOct 8, 2018Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF THE INTRAOCULAR LENS (MODEL ZCB00 +15.5 DIOPTER) WAS FOUND BROKEN UPON OPENING THE LENS CASE. NO PATIENT CONTACT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7942401 ↗
• InjuryAug 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCB00 15.5 DIOPTER LENS WAS INSERTED AND REMOVED FROM THE PATIENT'S OPERATIVE EYE BECAUSE THE PATIENT'S CAPSULAR BAG TORE. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. THE REPLACEMENT LENS WAS A SULCUS LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 7795705 ↗
• InjuryJul 17, 2018Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A ZCB00 15.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE. IT WAS LATER EXPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7697216 ↗
• MalfunctionMar 6, 2018Torn Material; Torn Material

  IT WAS REPORTED THAT A ZCB00 15.5 DIOPTER INTRAOCULAR LENS (IOL) WAS NOTICED TORN AFTER BEING IMPLANTED IN THE PATIENT'S RIGHT EYE (OD). THE LENS WAS THEREFORE REMOVED AND AN INCISION ENLARGEMENT WAS MADE WITH ONE SUTURE BEING USED. THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING GREAT POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7319373 ↗
• MalfunctionFeb 8, 2018Torn Material; Torn Material

  IT WAS REPORTED THAT CHUNK OF THE INTRAOCULAR LENS WAS MISSING. REPORTEDLY, THE LENS MAY HAVE POSSIBLY BEEN DAMAGED WHEN INSERTING INTO THE CARTRIDGE, HOWEVER IT WAS OBSERVED WHEN INSERTING INTO THE EYE. NO DAMAGE TO THE EYE OCCURRED AND THE PATIENT IS FINE. NO FURTHER INFORMATION WAS PROVIDED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7250559 ↗
• InjuryJun 22, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A DECREASE IN VISUAL ACUITY DUE TO HYPEROPIC SURPRISE. THE IOL WAS EXPLANTED FROM THE LEFT EYE. THE INCISION WAS NOT ENLARGED. A VITRECTOMY WAS NOT PERFORMED. NO OTHER MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE LENS WAS REPLACED WITH THE SAME MODEL, WITH A LARGER, 20.5 DIOPTER SIZE. THE PATIENT WAS DOING WELL WHEN DISCHARGED. VISUAL ACUITY PRE-OP (PRE-INITIAL IMPLANT): LP (LIGHT PERCEPTION), VISUAL ACUITY POST-OP (POST-INITIAL IMPLANT): 20/70-2, VISUAL ACUITY POST-OP (POST-REPLACEMENT): 20/30. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 6662317 ↗