BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPHTEC

    MDR report key: 6888191 · Received September 22, 2017

    Report

    Report Number
    8040449-2017-10001
    Event Type
    Injury
    Date Received
    September 22, 2017
    Date of Event
    February 9, 2017
    Report Date
    September 22, 2017
    Manufacturer
    OPHTEC
    Product Code
    HQL
    PMA / PMN Number
    P030028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED IOL WAS RECENTLY RETURNED TO OPHTEC FOR INVESTIGATION. INVESTIGATION CONFIRMS THAT THE EXPLANTED IOL IS A LENS MODEL 204001W. THE OPTIC OF THE RETURNED PRODUCT IS DAMAGED. THIS DAMAGE IS LIKELY CAUSED BY THE SURGEON DURING EXPLANTATION WHILE HE TRIED TO CUT THE PIOL IN TWO. IT IS DEFINITELY NOT MANUFACTURING RELATED. ONE OF THE SO CALLED CLAWS (HAPTIC) IS BENT/OVERSTRETCHED. THE TYPE OF DAMAGE TO THE CLAW IS TYPICALLY CAUSED BY HANDLING OF THE SURGEON DURING EXPLANTATION. A PIOL WITH THIS TYPE OF CLAW DAMAGE WOULD NOT HAVE BEEN PROPERLY FIXATED IN THE EYE FOR 19 YEARS. IT CAN THEREFORE BE CONCLUDED THAT THE BENT CLAW IS CAUSED DURING THE EXPLANTATION. APART FROM DAMAGE OBSERVED, PRODUCT MEETS SPECIFICATIONS. BASED ON INFORMATION AVAILABLE IT CANNOT BE DETERMINED WHAT HAS CAUSED THE SUBLUXATION. TYPICALLY THESE EVENTS OCCUR AFTER A BLUNT TRAUMA TO THE HEAD OR IN THE EARLY POST-OP PHASE DUE TO AN INSUFFICIENT AMOUNT OF IRIS BEING HOLD BY THE CLAW (SURGERY RELATED). SUBLUXATIONS ARE USUALLY TREATED BY RE-ENCLAVATING THE CLAW TO THE IRIS. IT IS NOT KNOWN WHY THE SURGEON DECIDED TO EXPLANT THE PIOL INSTEAD OF REFIXATING IT.

    Additional Manufacturer Narrative · 1

    (B)(6) WAS REPORTED TO OPHTEC (B)(4) (MANUFACTURER) ON APRIL 19, 2017. THE EVENT OCCURRED ON (B)(6) 2017, HOWEVER, THE LOCAL HOSPITAL INITIALLY REPORTED THIS EVENT TO (B)(6) AUTHORITIES. ONCE THE EVENT WAS RECEIVED AND PROCESSED BY (B)(6), THEY CONTACTED THE MANUFACTURER. THEREFORE, THERE WAS A 2 MONTH DELAY IN REPORTING THIS EVENT TO THE MANUFACTURER. ONCE THE INVESTIGATION OF THE COMPLAINT WAS COMPLETED BY THE MANUFACTURER (OPHTEC (B)(4)), THE EVENT WAS CLASSIFIED AS A REPORTABLE EVENT.

    Description of Event or Problem · 1

    THE PHAKIC INTRAOCULAR LENS WAS EXPLANTED FOLLOWING A SUBLUXATION AFTER APPROXIMATELY 19 YEARS PORT IMPLANTATION.

    Description of Event or Problem · 1

    THE PHAKIC INTRAOCULAR LENS WAS EXPLANTED FOLLOWING A SUBLUXATION AFTER APPROXIMATELY 19 YEARS POST IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667327 OPHTEC ARTISAN MYOPIA 6/8.5 HQL OPHTEC 204 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention