BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2032835 · Received March 29, 2011

    Report

    Report Number
    2023826-2011-00244
    Event Type
    Injury
    Date Received
    March 29, 2011
    Report Date
    March 3, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE LENS TO HAVE A NORMAL SLIGHT YELLOW TINT APPEARANCE. THE BULK OF THE LENS MATERIAL IS UNIFORM. FAINT LIGHT SCATTERING FROM THE LENS SURFACE WAS NOTED PROBABLY DUE TO PRESENCE MINUTE AMOUNT (FILM) OF THE ALLOGENEIC BIOLOGICAL SUBSTANCE AFTER SURGERY. THE HAPTIC WAS DAMAGED ON THE TOP LEFT SIDE. MICROSCOPIC EVALUATION OF THE LENS DID NOT REVEAL GEOMETRICAL DEFORMATION. THE EXPLANTED LENS SHOWS THE NORMAL APPEARANCE OF THE COLLAMER LENS IN BSS SOLUTION. (B)(4).

    Additional Manufacturer Narrative · 1

    MEDICAL REVIEW. PER MEDICAL REVIEW - REVIEW OF THE FILE INDICATES THAT THE LENS WAS NOT IMPLANTED IN ACCORDANCE WITH THE DFU REQUIREMENTS (E.G. PATIENT AGE BELOW 21 OR OVER 45 YEARS, ACD BELOW 2.8MM FOR ICL/TICL AND BELOW 3.0MM FOR VICL/VTICL, KERATOCONUS, PREGNANT OR NURSING PATIENTS, PATIENTS WITH LOW/ABNORMAL CORNEAL ENDOTHELIAL CELL DENSITY, FUCHS DYSTROPHY OR OTHER CORNEAL PATHOLOGY, PATIENTS WHO ARE AMBLYOPIC OR BLIND IN THE FELLOW EYE). OFF-LABEL USE OF THE DEVICE, NO CLINICAL DATA CAN SUPPORT THE COMPLAINT EVENT(S) OR THE EFFECT(S) ON THE EFFICACY AND SAFETY OF THE DEVICE. THIS INFORMATION HAS BEEN COMMUNICATED TO THE MEDICAL ADVISOR OF THE MANUFACTURER AND TO THE SURGEON IN CASE OF SEVERE DETERIORATION OF PATIENT HEALTH. BASED ON THE COMPLAINT HISTORY, MEDICAL REVIEW AND THE EVALUATION OF THE RETURNED PRODUCT, A POSSIBLE ROOT CAUSE OF THE EVENT HAS BEEN DETERMINED TO BE DUE TO THE OFF-LABEL USE OF THE LENS. (B)(4).

    Additional Manufacturer Narrative · 1

    SURGICAL PROCEDURE, SECONDARY SURGERY. CATARACT, INDUCED.(B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.0MM ICM120V4 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S EYE ON (B)(6) 1998. THE LENS WAS EXPLANTED ON (B)(6) 2011 DUE TO THE DEVELOPMENT OF A CATARACT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention CARTRIDGE MODEL AND LOT NUMBER UNKNOWN| FOAM TIP PLUNGER MODEL AND LOT NUMBER UNKNOWN| INJECTOR MODEL AND LOT NUMBER UNKNOWN