BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISYMM ASPHERIC INTRAOCULAR LENS

    MDR report key: 4777236 · Received May 15, 2015

    Report

    Report Number
    3006723646-2015-00412
    Event Type
    Injury
    Date Received
    May 15, 2015
    Date of Event
    April 20, 2015
    Report Date
    May 14, 2015
    Manufacturer
    HOYA SURGICAL OPTICS INC.
    Product Code
    HQL
    PMA / PMN Number
    P080004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENT IS ALSO UPDATING THE AGENCY ON NEW INFORMATION REGARDING THE PRODUCT INVESTIGATION CONDUCTED AS A RESULT OF THIS ADVERSE EVENT. THE PRODUCT INVESTIGATION COMPLETED BY (B)(6), HOYA QUALITY ASSURANCE DEPARTMENT, ON JUNE 16, 2015, FOUND THAT: THE WRONG DIOPTER POWER LENS WAS IMPLANTED BY THE DOCTOR. THE LENS HAD TO BE CUT AND EXPLANTED. ONE HAPTIC OF THE EXPLANTED LENS WAS DETACHED AT HAPTIC/OPTIC JUNCTION, AND A TRACE OF LUBRICANT WAS FOUND ON THE LENS. A REVIEW OF THE PRODUCTION RECORDS SHOWED NO IRREGULARITIES OR ABNORMALITIES DURING ITS MANUFACTURING AND/OR INSPECTION PROCESSES. THE ISSUE WAS DUE TO HUMAN ERROR.

    Description of Event or Problem · 1

    IT SEEMED TO BE A USER ERROR BASED ON THE COMPLAINT DESCRIPTION. THE DOCTOR DID NOT COMPLAINT ABOUT THE HSO LENS DIOPTER POWER THAT THEY PURCHASED. THE COMPLAINT DESCRIPTION STATED THAT THE DOCTOR INITIALLY PUT IN THE WRONG DIOPTER POWER INTO THE PT'S EYE. THE PT HAS BLURRED VISION AND CAME BACK TO THE DOCTOR. LENS HAD TO BE EXPLANTED AND THE CORRECT DIOPTER POWER WAS IMPLANTED.

    Description of Event or Problem · 1

    IT SEEMED TO BE A USER ERROR BASED ON THE COMPLAINT DESCRIPTION. THE DOCTOR DID NOT COMPLAIN ABOUT THE HSO LENS DIOPTER POWER THAT THEY PURCHASED. THE COMPLAINT DESCRIPTION STATED THAT THE DOCTOR INITIALLY PUT IN THE WRONG DIOPTER POWER INTO THE PATIENT'S EYE. THE PATIENT HAS BLURRED VISION AND CAME BACK TO THE DOCTOR. LENS HAD TO HE EXPLANTED AND THE CORRECT DIOPTER POWER WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317709 ISYMM ASPHERIC INTRAOCULAR LENS INTRAOCULAR LENS HQL HOYA SURGICAL OPTICS INC. FY-60AD

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention