TECNIS IOL ZCB00 (REF ZCB0000100)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474531512), received between Oct 8, 2017 and Nov 23, 2025 — classified as 4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ZCB00 MODEL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S EYE DURING A SECONDARY SURGICAL PROCEDURE FOR UNKNOWN REASONS. THE FOLLOWING ARE ALSO ALL UNKNOWNS: REPLACEMENT IOL INFORMATION AND PATIENT PROGNOSIS POST LENS EXPLANT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 23627998 ↗
• InjuryNov 23, 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 OPERATIVE EYE. FOR UNKNOWN REASONS, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE. INFORMATION ABOUT THE REPLACEMENT IOL IS UNKNOWN. PATIENT PROGNOSIS IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 23627886 ↗
• InjuryMay 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS PLANNED WITH THE TARGET REFRACTION -1.5D. POST IMPLANTATION, THE PATIENT HAD A SUB-REFRACTION OF -2.25D AND IS UNHAPPY. AN EXPLANT/EXCHANGE WAS PERFORMED IN THE LEFT EYE. THERE WAS NO INCISION ENLARGEMENT, SUTURES OR VITRECTOMY REQUIRED. THE REPLACEMENT LENS WAS ANOTHER LENS OF THE SAME MODEL BUT A LOWER DIOPTER (9.0). THE PATIENT IS REPORTED TO BE HAPPY WITH THE VISUAL OUTCOME AFTER THE EXPLANT/EXCHANGE PROCEDURE. A FOLLOW UP IS PLANNED FOR THE (B)(6) 2018.NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON AND JOHNSON SURGICAL VISION, INC.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 7517370 ↗
• InjuryOct 8, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCB00 10.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED ON (B)(6) 2017. REPORTEDLY, A VITRECTOMY WAS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 6927817 ↗