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TECNIS IOL ZMB00 (REF ZMB00U0110)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TECNIS MF 1- PIECE 6.0MM 11.0 US · Class 3 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474535442), received between May 2, 2019 and May 2, 2019 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • No Code Available1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO THE PATIENT NOT BEING HAPPY WITH THEIR INTERMEDIATE VISION IN THE LEFT EYE WITH THEIR MULTIFOCAL LENS. THE LENS WAS REPLACED WITH A SYMFONY LENS, AND THE PATIENT WAS REPORTED AS DOING WELL.

    Patient problems: No Code Available

    MAUDE report 8576048 ↗

Other LENS, MULTIFOCAL INTRAOCULAR devices

All LENS, MULTIFOCAL INTRAOCULAR devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.