TECNIS IOL ZCB00 (REF ZCB0000125)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 05050474531567), received between Apr 20, 2017 and Jul 13, 2021 — classified as 8 injuries, 7 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 16, 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.

• MalfunctionJul 13, 2021Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) LENS SURFACE WAS DEFECTIVE. LENS WAS IMPLANTED AND REMOVED FROM THE PATIENT'S RIGHT EYE DURING THE SAME PROCEDURE USING A SAME MODEL AND DIOPTER LENS. ADDITIONAL INFORMATION WAS PROVIDED THAT THE LENS WAS DEFECTIVE. THERE WAS A GOUGE IN THE CENTER OF THE LENS SURFACE, THEREFORE, IT WAS REMOVED FROM THE PATIENT'S EYE. THE PATIENT IS REPORTED TO BE DOING FINE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12164153 ↗
• InjuryDec 30, 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 IMPLANTED AND THEN REMOVED FROM THE PATIENT¿S RIGHT EYE DUE TO WRONG POWER PER OCULAR RESPONSE ANALYZER (ORA). THERE WAS INCISION ENLARGEMENT AND SUTURES REQUIRED. LENS WAS REPLACED USING THE BACK-UP IOL. THE PATIENT WAS FINE POST-OP. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9532556 ↗
• InjurySep 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING IMPLANTATION OF A ZCB00 INTRAOCULAR LENS (IOL), THE PATIENT HAD FIBROSIS OF ANTERIOR CAPSULE FOLLOWING IMPLANTATION AND EXPERIENCED POOR VISION. FIBROSIS APPEARED IN THE FOLLOWING WEEKS POST-OP. A SECONDARY SURGERY/MEDICAL INTERVENTION WAS DONE WHERE A NEW INCISION WAS MADE, AND THE FIBROSIS WAS REMOVED. NO EXPLANT IS PLANNED. ADDITIONAL INFORMATION STATES AFTER RESEARCH AND INVESTIGATION NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Fibrosis; Visual Impairment

  MAUDE report 9009993 ↗
• InjuryAug 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCB00 12.5 DIOPTER INTRAOCULAR LENS (IOL) IMPLANTED IN THE PATIENT'S RIGHT (OD) EYE ON (B)(6) 2019. IT WAS LATER EXPLANTED ON (B)(6) 2019 DUE TO UNSPECIFIED INJURY. A REPLACEMENT LENS IS A SAME MODEL ZCB00 WITH A HIGHER DIOPTER. REPORTEDLY, NO INCISION ENLARGEMENT OR SUTURE WAS USED. THE CUSTOMER ALSO INDICATED THAT THE IOL HAS BEEN DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8892131 ↗
• InjuryMay 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (MODEL ZCB00 +12.5 DIOPTER) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE (OD) DUE TO A REFRACTIVE MISS AND THE PATIENT BEING UNHAPPY. AT EXPLANT THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES WERE USED. A ZCB00 +16.0 WAS IMPLANTED AS THE REPLACEMENT LENS. THE PATIENT WAS REPORTED BEING WELL POST LENS EXCHANGE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8584981 ↗
• MalfunctionMar 12, 2019Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT DURING THE POST-OPERATIVE EXAMINATION, THE PHYSICIAN NOTICED MARKS ON THE IMPLANTED ZCB00 MONOFOCAL IOL (INTRAOCULAR LENS) THAT SEEM LIKE RINGS OF THE MULTIFOCAL LENSES. REPORTEDLY, THE SURGEON BELIEVES TO BE A FLAW IN THE LENS POLISHING PROCESS. THIS ISSUE, HOWEVER, DID NOT AFFECT THE PATIENT'S VISION. THEREFORE, THE LENS REMAINS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8411333 ↗
• MalfunctionFeb 6, 2019Break; Break

  IT WAS REPORTED THAT A ZCB00 12.5 DIOPTER INTRAOCULAR LENS (IOL) WAS DAMAGED. IT WAS REPORTED THAT THERE WAS NO PATIENT CONTACT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8309197 ↗
• InjuryAug 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCB00 12.5 DIOPTER INTRAOCULAR LENS WAS INSERTED AND THEN REMOVED DUE TO ISSUES WITH THE PATIENT'S EYE REQUIRING A VITRECTOMY TO BE PERFORMED. THE ACCOUNT COMMENTED THAT THERE WERE NO ISSUES WITH THE LENS. REPORTEDLY, THE LENS WAS DISCARDED BY THE ACCOUNT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vitrectomy

  MAUDE report 7741843 ↗
• MalfunctionJun 27, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DEBRIS WAS FOUND ON THE ZCB00 INTRAOCULAR LENS. NO PATIENT CONTACT WAS REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7640757 ↗
• InjurySep 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT THE PATIENT HAD A VITRECTOMY PERFORMED ASSOCIATED WITH A ZCB00 12.5 DIOPTER INTRAOCULAR LENS (IOL) IN THE LEFT EYE. FURTHER INFORMATION WAS PROVIDED AND REPORTED THAT THERE WAS ALSO AN INCISION ENLARGEMENT AS THE LENS WAS REMOVED AND REPLACED FROM THE PATIENTS OPERATIVE EYE DUE TO PATIENT ANATOMY ISSUES. REPORTEDLY, THERE WAS NO PATIENT INJURY. A TEAR WAS REPORTED IN FOLLOW UP, BUT IT'S UNKNOWN WHEN THE TEAR OCCURRED. ALSO, IT'S UNKNOWN WHETHER OR NOT THE LENS WAS IMPLANTED AT THAT TIME OR DURING PHACOEMULSIFICATION. THE LENS WAS REPLACED WITH A SULCUS LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; No Code Available; Vitrectomy

  MAUDE report 6867494 ↗
• MalfunctionAug 25, 2017Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD A BROKEN HAPTIC. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 6822736 ↗
• MalfunctionAug 20, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS DEBRIS ON A TECNIS 1-PIECE MONOFOCAL INTRAOCULAR LENS (IOL), MODEL ZCB00 12.5 DIOPTERS. THE IOL WAS NOT IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6806611 ↗
• InjuryMay 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAPSULE TEAR OCCURRED AND A ZCB00 12.5 DIOPTER INTRAOCULAR LENS (IOL) WAS REMOVED FROM THE EYE. THE CUSTOMER THINKS THE PRODUCT WAS DISCARDED AND THEREFORE NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 6558902 ↗
• MalfunctionMay 9, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A WHITE SPECK WAS NOTICED ON THE POSTERIOR SURFACE OF THE OPTIC OF AN INTRAOCULAR LENS (IOL). REPORTEDLY, THE SPECK WAS NOTICED WHEN THE LENS WAS REMOVED FROM THE LENS CASE. NO PATIENT CONTACT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6553362 ↗
• InjuryApr 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT''S EYE DEVELOPED AN INFECTION AFTER IMPLANTATION OF A ZCB00 12.5 DIOPTER INTRAOCULAR LENS (IOL). THE PHYSICIAN INSPECTED THE LENS AND OBSERVED THAT THERE WAS NO ISSUE WITH THE IOL, NO ISSUE WITH THE SURGERY AND NO ISSUE WITH THE HOSPITAL. THE LENS REMAINS IMPLANTED AND THERE IS NO PLAN FOR EXPLANT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Inflammation

  MAUDE report 6509230 ↗