BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 7360340 · Received March 21, 2018

    Report

    Report Number
    2648035-2018-00404
    Event Type
    Injury
    Date Received
    March 21, 2018
    Date of Event
    September 25, 2017
    Report Date
    April 18, 2018
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SERIAL NUMBER WAS NOT PROVIDED. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF ADDITIONAL INFORMATION IT WAS LEARNED THIS IS AN INVESTIGATIONAL DEVICE AND IS NOT SAME OR SIMILAR TO PRODUCT DISTRIBUTED/SOLD IN THE UNITED STATES, THEREFORE A SUPPLEMENTAL REPORT IS NOT REQUIRED AND NO FURTHER INFORMATION WILL BE PROVIDED UNDER THIS MANUFACTURER REPORT NUMBER. IN THE INITIAL MDR PMA # P980040 (IF THIS WAS INITIALLY POPULATED) WAS PROVIDED HOWEVER THIS IS NO LONGER APPLICABLE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED HALOS, STARBURSTS, SENSITIVITY TO LIGHT AND POOR VISION IN BOTH EYES (OU) AFTER IMPLANTATION OF A MONFOCAL INTRAOCULAR LENS (IOL) IN EACH EYE. INITIALLY, IT WAS REPORTED THAT AT THE ONE-MONTH POST OP EXAM, THE PATIENT WAS VERY BOTHERED BY THE HALOS AND COULD NOT SEE WITH THE LEFT EYE. THE PATIENT ¿S COMMENTS WERE OF VERY BOTHERED BY THE STARBURSTS, SENSITIVITY TO LIGHT, STREAKS OF LIGHT AND POOR LOW LIGHT VISION WHEN DRIVING, WORKING AND READING. THE PATIENT NOTED EXPERIENCING VISUAL SYMPTOMS AS BOTHERSOME ENOUGH TO WANT TO HAVE LENSES REMOVED. THE SURGERY CENTER CLARIFIED THAT THE PATIENT DID NOT HAVE ANY SPONTANEOUS REPORT OF PHOTOPHOBIA AND THE PATIENT DID NOT EXPERIENCE SENSITIVITY DURING DAY OR NIGHT BUT TO THE LIGHT AT DAWN OR DUSK. AT ONE MONTH, THE BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) WAS 20/25-2 FOR LEFT EYE (OS) AND 20/20 FOR RIGHT EYE (OD). THE PATIENT WAS SEEN AT A 6-MONTH POST OP EXAM. THE PATIENT CONTINUED TO EXPERIENCE THE HALOS, GLARES, AND STARBURSTS. THE PATIENT¿S COMMENTS WERE OF SENSITIVITY TO LIGHT WHILE DRIVING OR WEARING ANY TYPE OF SUNGLASSES. THE PATIENT INDICATED BEING OFTEN VERY BOTHERED BY OCCLUSIONS AND POOR LOW LIGHT VISION ALL THE TIME WHILE READING OR DRIVING. BCDVA AT 6-MONTHS WAS 20/25+1 OD AND 20/25-2 2 (OS). AT THIS TIME, THERE IS NO PLAN FOR SECONDARY SURGICAL INTERVENTION. THE SURGERY CENTER STATED THE SYMPTOMS DID NOT CAUSE SIGNIFICANT IMPAIRMENT, HOWEVER THE OUTCOME IS NOTED TO SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. THIS REPORT IS FOR THE RIGHT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202894 UNKNOWN MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other