BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 3081469 · Received April 29, 2013

    Report

    Report Number
    2023826-2013-00323
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    September 18, 2009
    Report Date
    April 5, 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

    EVALUATION METHOD: WORK ORDER SEARCH, MEDICAL REVIEW. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND ONE SIMILAR COMPLAINT WAS FOUND WITHIN THE WORK ORDER. VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND NO VISIBLE DAMAGE TO THE LENS. THE LENS WAS RETURNED DRY. THE LENS WAS REHYDRATED IN BSS FOR RE-MEASUREMENT. THE LENS LENGTH WAS MEASURED AND THE RESULT OF THE MEASUREMENT WAS COMPARED AGAINST THE ORIGINAL VALUE AND THE LENS WAS FOUND TO BE IN SPECIFICATION. MEDICAL REVIEW - CLINICAL STUDIES HAVE SHOWN THAT ANTERIOR SUBCAPSULAR CATARACT OCCURS IN 1.3% OF PATIENTS WHERE AN ICL HAS BEEN IMPLANTED, FOLLOWING THE RECOMMENDATIONS FOR USE. THIS USUALLY OCCURS WITHIN THE 1ST 6 MONTHS POST-OP. THE MOST PROBABLE CAUSE HAS BEEN DETERMINED TO BE CRYSTALLINE LENS TOUCH DURING SURGERY WHICH COULD HAVE BEEN EITHER FROM THE INSTRUMENTS USED OR THE ICL ITSELF. 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).

    Additional Manufacturer Narrative · 1

    (B)(4) - CATARACT, INDUCED; NO INFORMATION. (B)(4). LENS NOT RETURNED.

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 11.5MM ICM115V4 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2009. AN ANTERIOR SUBCAPSULAR OPACITY WAS NOTED ON (B)(6) 2009. THE LENS WAS EXPLANTED ON (B)(6) 2012 AND CATARACT SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185700 ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY ICM115V4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention INJECTOR MODEL AND LOT NUMBER UNK| CARTRIDGE MODEL AND LOT NUMBER UNK