BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 3250868 · Received July 29, 2013

    Report

    Report Number
    2023826-2013-00604
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    April 23, 2013
    Report Date
    July 1, 2013
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    METHOD: WORK ORDER SEARCH, DEVICE HISTORY RECORD REVIEW, MEDICAL REVIEW. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND NO VISIBLE DAMAGE TO THE LENS. THE LENS WAS RETURNED DRY. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NOTHING WAS FOUND IN THE MANUFACTURING, STERILIZATION AND PACKAGING PROCESSES OF THIS LENS THAT WAS THE ROOT CAUSE OF THE COMPLAINT. MEDICAL REVIEW - INTRAOCULAR INFLAMMATION AFTER INTRAOCULAR SURGERY IS A COMMON EVENT HOWEVER THIS IS USUALLY MILD AND DOES NOT REQUIRE ANY ADDITIONAL INTERVENTIONS THAN THE STANDARD POST-OPERATIVE REGIMEN OF MEDICATIONS. IN SOME CASES THE DEGREE OF INFLAMMATION MAY BE MORE SEVERE. SEVERITY DEPENDS ON THE CAUSE: SURGICAL TRAUMA, SYSTEMIC CONDITIONS, PRESENCE OF TOXIC SUBSTANCES, INFECTION, ETC. PROMPT TREATMENT AIMED TO CONTROL INFLAMMATION IS CRITICAL TO AVOID FURTHER ADVERSE EVENTS. IT IS UNLIKELY THAT THE ICL WAS THE CAUSE OF THIS ADVERSE EVENT. EVERY ICL UNDERGOES A STEAM STERILIZATION PROCESS. BEFORE RELEASING THE LENS, QUALITY DEPARTMENT VERIFIES THE FOLLOWING FOR EACH ICL LOT: STERILIZATION CYCLE PARAMETERS (TIME, TEMPERATURE AND PRESSURE) MUST BE MET. BIOLOGICAL INDICATORS USED FOR EVERY STERILIZATION BATCH MUST BE IN ACCORDANCE WITH SPECIFICATIONS TO DEMONSTRATE STERILITY. LAL TESTING MUST BE IN ACCORDANCE WITH SPECIFICATIONS TO ENSURE THAT THE PRODUCT IS FREE FROM ANY ENDOTOXIN. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, MEDICAL REVIEW, DEVICE HISTORY RECORD REVIEW AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.0MM ICM120V4 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2013. THE LENS WAS EXPLANTED ON (B)(6) 2013 DUE TO INFLAMMATION. A VITRECTOMY WAS PERFORMED. THE PATIENT'S BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/25.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED - THE REPORTER INDICATED THE PATIENT NOTICED SUDDEN DECREASED VISION THREE DAYS AFTER SURGERY WHICH WORSENED TO 20/125 THE SIXTH POSTOPERATIVE DAY. THE SURGEON ADMINISTERED MEDICATION AND OVER THE COURSE OF THREE WEEKS BCVA IMPROVED TO 20/25. THE RAPID RECOVERY AND LACK OF OTHER SIGNS INDICATES THAT THIS WAS MOST LIKELY INTRAOCULAR INFLAMMATION RATHER THAN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353247 ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY ICM120V4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention CARTRIDGE MODEL AND LOT NUMBER UNK| INJECTOR MODEL AND LOT NUMBER UNK