BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 3150832 · Received June 6, 2013

    Report

    Report Number
    2023826-2013-00461
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    April 6, 2013
    Report Date
    May 9, 2013
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LENS NOT RETURNED. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: WORK ORDER SEARCH, MEDICAL REVIEW. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE 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 - 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, FUCH'S 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 STAAR SURGICAL AND TO THE SURGEON IN CASE OF SEVERE DETERIORATION OF PATIENT HEALTH. 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).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.0MM ICM130V4 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT EYE (OD). ON (B)(6) 2013, THE SURGEON DETECTED EXCESSIVE VAULT, ASSOCIATED WITH SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES AND GLARES/HALOS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251202 ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY ICM130V4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention INJECTOR MODEL AND LOT NUMBER UNK| CARTRIDGE MODEL AND LOT NUMBER UNK