TECNIS IOL ZCB00 (REF ZCB0000310)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474531932), received between Aug 20, 2019 and Dec 13, 2019 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS MYOPIC POST-OPERATIVE IN THE LEFT EYE. THE INTRAOCULAR LENS (IOL) WAS THEREFORE EXPLANTED. THE REPLACEMENT LENS WAS A SAME MODEL, BUT A LOWER DIOPTER. THE PATIENT IS DOING AS EXPECTED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Blurred Vision; No Code Available; Visual Disturbances

  MAUDE report 9466509 ↗
• InjuryAug 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST IMPLANT OF A MODEL ZCB00 31.0 DIOPTER INTRAOCULAR LENS, THE PATIENT EXPERIENCED MYOPIC OUTCOME RESULTING IN DECREASED VISUAL ACUITY. THERE WAS NO VITRECTOMY, OR INCISION ENLARGEMENT REQUIRED, HOWEVER A SUTURE WAS PLACED. THE REPLACEMENT LENS WAS ANOTHER ZCB00 OF A LOWER DIOPTER (28.0). PATIENT WAS REPORTED AS DOING FINE WHEN DISCHARGED. VISUAL ACUITY PRE-OP (PRE-INITIAL IMPLANT): CF (COUNTING FINGERS). VISUAL ACUITY POST-OP (POST-INITIAL IMPLANT):20/80-2. VISUAL ACUITY POST-OP (POST-REPLACEMENT):20/30+2. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 8913613 ↗