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TECNIS IOL ZMB00 (REF ZMB00U0290)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TECNIS MF 1- PIECE 6.0MM 29.0 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 05050474535800), received between Aug 25, 2016 and Aug 25, 2016 — 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
  • Visual Disturbances1

Recent adverse event reports

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

  • InjuryAug 25, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE SURGEON PERFORMED AN INTRAOCULAR LENS EXCHANGE/EXPLANT AFTER DIAGNOSIS OF DYSPHOTOPSIA. THERE WAS NO INCISION ENLARGEMENT AND NO INJURY. NO SUTURES WERE USED. ANOTHER LENS OF A DIFFERENT MODEL WAS USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Code Available; Visual Disturbances

    MAUDE report 5904843 ↗

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.