BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2083683 · Received May 10, 2011

    Report

    Report Number
    2023826-2011-00388
    Event Type
    Injury
    Date Received
    May 10, 2011
    Report Date
    April 13, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD: MEDICAL REVIEW. RESULTS: MEDICAL REVIEW - REVIEW OF THIS FILE INDICATES THAT THE PATIENT IS EXPERIENCING DRY EYES. DRY EYES BECOME MORE PRONOUNCED AFTER THE CORNEAL NERVES ARE CUT DURING CREATION OF A FLAP FOR LASIK BUT NOT DURING ICL IMPLANTATION. DRY EYES IN THIS CASE MUST HAVE BEEN PRE-EXISTING, OR IS ONLY DUE TO THE DROPS BEING ADMINISTERED POST-OP. IT IS TRIVIAL AND TEMPORARY THEREFORE NOT MDR REPORTABLE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) - EYE INFLAMED, DEVICE REMAINS IMPLANTED, EVALUATION METHOD: LENS WORK ORDER SEARCH. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. CONCLUSIONS: (NO CONCLUSION CAN BE DRAWN). BASED ON THE COMPLAINT HISTORY AND WORK ORDER SEARCH, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4). LENS REMAINS IMPLANTED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THE SURGEON IMPLANTED A 12.6MM MICL 12.6 IMPLANTABLE COLLAMER LENS IN HER LEFT EYE (OS). THE PATIENT REPORTED HAVING BEEN PRESCRIBED EYE DROPS FOR AT LEAST THREE MONTHS BECAUSE THE INSIDE OF HER EYE WAS INFLAMED. THE FACILITY REPORTED THEY DID NOT AGREE WITH THE PATIENT'S RESPONSE AND THE PATIENT WAS PRESCRIBED RESTASIS FOR DRY EYES. THE ICL REMAINS IMPLANTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED - THE PATIENT REPORTED SHE MISUNDERSTOOD WHAT THE DROPS WERE FOR, AND THERE IS NO PROBLEM AT THIS TIME, NO PHYSICIAN HAS MADE THE STATEMENT THERE WAS ANY INFLAMMATION TO HER EYES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY MICL 12.6

    Patients

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