BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2202836 · Received August 11, 2011

    Report

    Report Number
    2023826-2011-00710
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    April 13, 2011
    Report Date
    July 13, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - REFRACTIVE SURPRISE, HALO, GLARE, DEVICE REMAINS IMPLANTED, LABELED, LENS, VAULTING, EXCESSIVE. (B)(4). LENS REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    LENS WORK ORDER SEARCH, MEDICAL REVIEW. A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. MEDICAL REVIEW - USUALLY, THE PERCEPTION OF GLARE/HALOS IS A COMMON COMPLAINT AFTER CORNEAL BASED SURGERY AND A LESS OF A PROBLEM AFTER IMPLANTATION OF INTRAOCULAR LENSES; HOWEVER THE PREOPERATIVE PUPIL SIZE, PREOPERATIVE LEVEL OF MYOPIA AS WELL AS THE SIZE OF THE IMPLANTS OPTICAL ZONE MAY INFLUENCE THE RECEPTION OF THESE HALOS. USUALLY THE PERCEPTION OF HALOS IS TRANSIENT, ONLY RELATED TO SOME LIGHTING CONDITIONS AND DIMINISHES/DISAPPEARS OVER A COURSE OF WEEKS/MONTHS. IN SOME CASES THE HALOS MAY PERSIST AND BE SIGNIFICANT, IN THESE SITUATIONS THE IMPLANT CAN BE EXPLANTED IF PATIENT IS HAVING SIGNIFICANT DISTURBANCES. TARGET POST-OPERATIVE SEQ (SPHERICAL EQUIVALENT) WAS -0.21 D, ACHIEVED WAS -1.00 D. DEVIATION FROM EXPECTED WAS -0.79 THEREFORE THE PATIENT IS WITHIN 1 D FROM EXPECTED. SEVERAL FACTORS MAY BE INVOLVED IN A POST-OPERATIVE REFRACTIVE SURPRISE, INCLUDING INAPPROPRIATE REFRACTIVE SURGICAL PLANNING, A WRONG LENS CALCULATION/SELECTION, PREOPERATIVE INACCURATE DETERMINATION OF THE EYE'S MEASUREMENTS TO DETERMINE THE POWER OF THE ICL, INDUCED REFRACTIVE CHANGE BY INCISIONS, UNSTABLE CORNEA AND/OR REFRACTION PRIOR TO IMPLANTATION, CL-INDUCED WARPAGE, ETC. NO CONCLUSION CAN BE DRAWN: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND MEDICAL REVIEW, 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 13.2MM VICM 13.2 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2011. THE LENS HAD AN EXCESSIVE VAULT; THERE WAS A REFRACTIVE SURPRISE AND THE PATIENT EXPERIENCED GLARES AND HALOS DURING THE DAY. THE ICL REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY VICM 13.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR FOAM TIP PLUNGER: MODEL AND LOT NUMBER UNKNOWN| CARTRIDGE: MODEL AND LOT NUMBER UNKNOWN| INJECTOR: MODEL AND LOT NUMBER UNKNOWN