BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS ITEC PRELOADED 1-PIECE IOL

    MDR report key: 7281532 · Received February 19, 2018

    Report

    Report Number
    2648035-2018-00261
    Event Type
    Malfunction
    Date Received
    February 19, 2018
    Date of Event
    December 5, 2017
    Report Date
    March 29, 2018
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF IMPLANTED, GIVE DATE: UNKNOWN, IF THE LENS WAS IMPLANTED. IF EXPLANTED, GIVE DATE: UNKNOWN, IF THE LENS WAS IMPLANTED AND THEREFORE UNKNOWN IF EXPLANTED. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO / CORRECTED DATA: ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE EVENT OCCURRED ON (B)(6) 2017. THE HAPTIC OF THE INTRAOCULAR LENS (IOL) BROKE DURING IMPLANTATION INTO THE EYE. THE LENS WAS CUT, REMOVED AND ANOTHER LENS WAS IMPLANTED DURING THE SAME SURGICAL PROCEDURE. NO INCISION ENLARGEMENT AND NO VITRECTOMY WAS PERFORMED. THE PATIENT OUTCOME WAS REPORTED AS EXCELLENT. WITH THIS ADDITIONAL INFORMATION THIS COMPLAINT HAS NOW BEEN DETERMINED NOT TO BE A REPORTABLE EVENT. NO FURTHER REPORTS WILL BE SUBMITTED UNDER THIS MANUFACTURER REPORT NUMBER 2648035-2018-00261. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HAPTIC OF AN INTRAOCULAR LENS (IOL) BROKE DURING IMPLANTATION INTO THE EYE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124080 TECNIS ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS PCB00

    Patients

    Seq Age Sex Outcome Treatment
    1