BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1870102 · Received October 5, 2010

    Report

    Report Number
    2023826-2010-00944
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    June 15, 2010
    Report Date
    September 15, 2010
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - SECONDARY SURGERY - (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: WORK ORDER SEARCH, MEDICAL REVIEW. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND. VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND TWO HAPTICS TORN AND BROKEN. THE LENS WAS RETURNED IN LIQUID. PER MEDICAL REVIEW - ACCORDING TO USE FMEA (FAILURE MODES AND EFFECT ANALYSIS) IT HAS BEEN DETERMINED THAT EXCESSIVE VAULTING IS A CONSEQUENCE OF A WRONG LENS USE FAILURE MODE (I.E. IMPROPER WHITE TO WHITE MEASUREMENT, VARIABILITY OF THE WHITE TO WHITE MEASUREMENTS BASED UPON DIFFERENT TECHNIQUES UTILIZED, IMPROPER SULCUS TO SULCUS MEASUREMENT (IF UBM USED), AND PATIENT CONDITION; POOR CORRELATION OF WHITE TO WHITE MEASUREMENT AND LENGTH OF CILIARY SULCUS IN AN INDIVIDUAL CASE; IRREGULAR CILIARY SULCUS OR CILIARY SULCUS CYST). A HIGHER THAN IDEAL VAULTING IN THE ABSENCE OF SIGN AND/OR SYMPTOMS DOES NOT NEED AN EXCHANGE. HOWEVER, THE SURGEON MAY DECIDE TO EXCHANGE IF HE DETERMINES THAT THIS CONDITION MAY AFFECT THE OUTCOME OF THE PATIENT'S VISION. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN. BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, MEDICAL 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 13.0 MM ICM130V4 IMPLANTABLE COLLAMER LENS IN THE PT'S LEFT EYE (OS) ON (B)(6)2010. THE LENS WAS EXPLANTED ON (B)(6)2010, DUE TO EXCESSIVE VAULTING. SUBSEQUENTLY, THE PT EXPERIENCED SHALLOWING OF THE ANTERIOR CHAMBER. THE ICL WAS EXCHANGED FOR A SHORTER LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL CO. ICM130V4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention INJECTOR: MODEL AND LOT NUMBER UNK| FOAM TIP PLUNGER: MODEL AND LOT NUMBER UNK| CARTRIDGE: MODEL AND LOT NUMBER UNK