TECNIS IOL ZCB00 (REF ZCB0000115)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05050474531543), received between Jun 2, 2017 and Oct 22, 2021 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryOct 22, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO THE LENS DISLOCATING. A VITRECTOMY, AN IRIDOTOMY, AND NYLON SUTURE WERE REQUIRED. THERE WAS NO PATIENT INJURY. THE SURGERY WAS COMPLETED USING A NON-JOHNSON & JOHNSON REPLACEMENT LENS. THE PATIENT IS DOING FINE POST-OPERATIVELY. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 12686556 ↗
• InjuryJan 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXCHANGED DUE TO A REFRACTIVE MISS. THERE IS NOT A SUSPICION OF A PROBLEM WITH THE SUSPECT IOL. THIS IOL WAS DISCARDED. THE PATIENT IS PRESUMED TO BE DOING FINE. NO COMPLICATION DURING EXCHANGE AND NOT SUTURE USED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 11137556 ↗
• InjuryNov 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING BLURRED VISION AND SEE''S RAYS LIKE A SWORD OF LIGHT WHEN HE DRIVES AT NIGHT WITH AN INTRAOCULAR LENS (IOL) IN THE RIGHT EYE. ABOUT TWO WEEKS AFTER SURGERY IN THE RIGHT EYE, THE PATIENT STARTED DRIVING AT NIGHT AND NOTICED THE HEADLIGHTS ON ON-COMING TRAFFIC LOOKED LIKE RAYS OF LIGHT COMING OFF OF IT. THE VISUAL ISSUE SIGNIFICANTLY INTERFERES WITH NIGHT DRIVING. THE PATIENT IS SCHEDULED TO HAVE A LASER TREATMENT ON (B)(6) 2020. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION. PATIENT HAD BILATERAL LENS IMPLANTS. THIS REPORT CAPTURES THE LENS IMPLANTED IN PATIENTS RIGHT EYE. A SEPARATE REPORT WILL BE FILED FOR THE LEFT EYE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 10783049 ↗
• InjuryJul 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF OBSCURATION IN HER VISION ALONG WITH IT BEING BLURRY SINCE DAY ONE POST-IMPLANT IN THE LEFT EYE. THE LENS WAS EXPLANTED LENS WAS REPLACED WITH A DIFFERENT MODEL BUT SAME DIOPTER. A VITRECTOMY WAS REQUIRED. THERE WAS NO PATIENT INJURY REPORTED. THE EXPLANTED LENS WAS DISCARDED. TWO WEEKS POST-EXCHANGE THE PATIENT¿S VISION HAS IMPROVED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 8769737 ↗
• MalfunctionFeb 8, 2019Scratched Material; Scratched Material

  IT WAS REPORTED THAT A ZCB00 11.5 DIOPTER INTRAOCULAR LENS (IOL) WAS SCRATCHED WHEN REMOVING FROM THE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8324311 ↗
• InjuryJun 15, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A ZCB00 11.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2017. IT WAS LATER EXPLANTED ON 05/16/2018 BECAUSE THE PATIENT DEVELOPED ANISOMETROPIA AND BECAUSE OF A MECHANICAL COMPLICATION. THERE WAS NO INCISION ENLARGEMENT. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 8.5. REPORTEDLY, THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7604517 ↗
• InjuryMay 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCB00 11.5 DIOPTER LENS WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7545502 ↗
• InjuryMay 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCB00 11.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE AT ONE POINT IN TIME AND WAS LATER EXPLANTED ON A DIFFERENT SURGICAL DATE. REPORTEDLY, THE EVENT ''WOULD HAVE BEEN AROUND THE BEGINNING OF (B)(6) 2017, HOWEVER, THIS DOESN'T EXPLAIN IF THIS DATE PERTAINS TO THE IMPLANT OR EXPLANT DATE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7545326 ↗
• InjuryJun 2, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (MODEL ZCB00 +11.5 DIOPTERS) WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE FROM THE EYE OF A (B)(6) MALE PATIENT. REPORTEDLY, THE PATIENT EXPERIENCED BLURRED VISION AND THE LENS HAD A DEFECT IN THE CENTER OF THE OPTIC. ANOTHER LENS, SAME MODEL SMALLER DIOPTER (+9.0), WAS IMPLANTED. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNED THAT THERE WAS NO PATIENT POST-OPERATION INJURY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 6608005 ↗