BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2152004 · Received July 7, 2011

    Report

    Report Number
    2023826-2011-00603
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    March 8, 2011
    Report Date
    June 9, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    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

    LENS WORK ORDER SEARCH & DEVICE HISTORY REVIEW. VISUAL INSPECTION OF THE RETURNED LENS SHOWED THE LENS WAS RETURNED DRY WITH A SURGICAL RESIDUE ON IT, HOWEVER, THERE WAS NO VISIBLE DAMAGE TO THE DEVICE. A LENS WORK ORDER SEARCH WAS PERFORMED AND THERE WERE NO SIMILAR COMPLAINTS FOUND. DEVICE HISTORY REVIEW - BASED ON THE FACT THAT NO MARKS WERE SEEN DURING THE EVALUATION OF THE LENS, IT HAS BEEN DETERMINED THAT NOTHING IN THE MANUFACTURING WAS THE ROOT CAUSE OF THIS COMPLAINT. UNABLE TO CONFIRM: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, MEDICAL AND DEVICE HISTORY REVIEW, WE WERE UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE OF THE EVENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON INSERTED AN (B)(4) IMPLANTABLE COLLAMER LENS ON (B)(6) 2010. THE PATIENT KEPT COMPLAINING ABOUT SCATTERING WHEN SHE RESPONSE TO LIGHT OR COLOR. IT SEEMS THAT THERE WAS A LOOK LIKE CONCENTRIC CIRCLE IN OPTIC AT SLIT LAMP EXAMINATION. THE LENS WAS EXCHANGED FOR ANOTHER SAME MODEL LENS ON (B)(6) 2011 AND THIS RESOLVED THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY ICM120V4 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention