BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS EYHANCE

    MDR report key: 6049427 · Received October 21, 2016

    Report

    Report Number
    2648035-2016-01646
    Event Type
    Malfunction
    Date Received
    October 21, 2016
    Date of Event
    August 18, 2016
    Report Date
    October 24, 2018
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO/CORRECTED DATA: ADDITIONAL INFORMATION WAS RECEIVED AND THE LENS MODEL ICB00 AND SERIAL NUMBER ((B)(4)) WAS REVEALED. ICB00 LENSES ARE NOT MARKETED IN THE US (UNITED STATES) AND THEY ARE NOT SIMILAR TO A PRODUCT MARKETED IN THE US. THIS EVENT HAS NOW BEEN DETERMINED NOT TO BE A REPORTABLE EVENT. NO FURTHER REPORTS WILL BE SUBMITTED UNDER THIS MANUFACTURER REPORT NUMBER. THE FOLLOWING FIELDS WERE UPDATED: BRAND NAME: TECNIS EYHANCE. MODEL #: ICB00, CATALOG #: ICB0000225, SERIAL NUMBER: (B)(4), EXPIRATION DATE: 03/23/2021. UNIQUE IDENTIFIER (UDI#): (B)(4). SITE ADDRESS WAS UPDATED (B)(4). PMA/510(K) #: UPDATED FROM P980040 TO NULL. ICB00 LENSES ARE NOT MARKETED IN THE US (UNITED STATES) AND THEY ARE NOT SAME OR SIMILAR TO A PRODUCT MARKETED IN THE US. DEVICE MANUFACTURE DATE(S): 03/23/2016. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION THAT THE LENS WAS EXPLANTED.(B)(6). DEVICE MANUFACTURE DATE(S): UNKNOWN, BECAUSE THE SERIAL NUMBER WAS NOT PROVIDED.ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANTATION OF AN INTRAOCULAR LENS (IOL) IN THE LEFT EYE OF A FEMALE PATIENT, THE HAPTIC WAS ATTACHED TO THE OPTIC FOR A LONG TIME. REPORTEDLY IT IS UNKNOWN FOR HOW LONG BUT PERCEIVED LONGER THAN USUAL. THERE WERE NO COMPLICATIONS OR INJURIES AND THE PATIENT WAS REPORTED BEING RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700021 TECNIS EYHANCE MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ICB00

    Patients

    Seq Age Sex Outcome Treatment
    1