BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2992791 · Received March 7, 2013

    Report

    Report Number
    2023826-2013-00203
    Event Type
    Injury
    Date Received
    March 7, 2013
    Report Date
    February 14, 2013
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: WORK ORDER SEARCH, MEDICAL REVIEW, DEVICE HISTORY RECORD REVIEW. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. 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 - TASS IS A STERILE INFLAMMATORY REACTION INVOLVING THE ANTERIOR SEGMENT WHICH COMMONLY INDUCES HYPOPYON FORMATION AND COULD OCCUR AFTER ANY TYPE OF INTRAOCULAR SURGERY. MOST COMMON COMPLAINTS ARE BLURRED VISION, OCULAR PAIN AND EYE REDNESS. IOP MAY BE INCREASED IF INFLAMMATION IS SEVERE AND CLOGS THE TRABECULAR MESHWORK. IT IMPROVES WITH TOPICAL/ORAL STEROIDS AND COMMONLY PRESENTS WITH DIFFUSE CORNEAL EDEMA. IF THIS IS TASS OR ANOTHER TYPE OF ACUTE INFLAMMATORY REACTION IT IS NOT CLEAR. MOST OF REPORTED SEVERE ACUTE INFLAMMATIONS AFTER INTRAOCULAR SURGERY ARE THOUGHT TO BE AN IMMUNOLOGIC REACTION TO SOME SUBSTANCES IN THE ANTERIOR CHAMBER. THESE SUBSTANCES COULD COME FROM OUTSIDE THE EYE, USED INTRA-OPERATIVELY (BSS, OVDS, INTRACAMERAL DRUGS), OR COMING FROM SURGICAL INSTRUMENTS. 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. (B)(4) 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 AND THE DEVICE HISTORY RECORD REVIEW, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER? NO - LENS REMAINS IMPLANTED. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED - THE REPORTER STATED THE LENS WAS IMPLANTED ON (B)(6) 2012

    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). THE REPORTER INDICATED THE PATIENT HAD ELEVATED IOP, DILATED PUPIL, ANTERIOR SUBCAPSULAR LENS OPACITIES, CORNEAL EDEMA AND TASS. THE REPORTER INDICATED THERE IS FIBRIN ON THE ICL. THE PATIENT WAS GIVEN TOPICAL AND ORAL STEROIDS. THE PATIENT'S UCVA WAS 20/30.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97354 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