BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 4103776 · Received September 19, 2014

    Report

    Report Number
    2023826-2014-00749
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    May 1, 2013
    Report Date
    August 22, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION CODES: METHOD -(OTHER): WORK ORDER SEARCH RESULTS - (OTHER): 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 IMPLANTED.

    Additional Manufacturer Narrative · 1

    METHOD: MEDICAL REVIEW. RESULTS: PER MEDICAL REVIEW - REPORTEDLY, BY A PATIENT, INTERVENTION FOR "FURTHER FIXING ASTIGMATISM" WAS PERFORMED FOLLOWING ICL IMPLANTATION ALMOST TWO YEARS AGO. ACCORDING TO THE DCR, DATED ON 09/04/2014, LRI (RELAXING LIMBAL INCISION) WAS PERFORMED ON (B)(6) 2013 TO ADDRESS RESIDUAL REFRACTIVE ERROR (ASTIGMATISM) DUE TO A PATIENT PRE-EXISTING OCULAR CONDITION (CORNEAL ASTIGMATISM) AND WAS NOT RELATED TO THE DEVICE. NO OTHER MEDICALLY OR SURGICALLY INTERVENTION WAS PERFORMED OR SCHEDULED. THE PROGNOSIS WAS GOOD AND VA WAS 20/20. PER DFU "INDICATIONS THE VISIAN ICL IS INDICATED FOR USE IN ADULTS 21-45 YEARS OF AGE - FOR THE CORRECTION OF MYOPIA IN ADULTS WITH MYOPIA RANGING FROM -3.0D TO <-15.0D WITH LESS THAN OR EQUAL TO 2.5D OF ASTIGMATISM AT THE SPECTACLE PLANE; FOR THE REDUCTION OF MYOPIA IN ADULTS WITH MYOPIA RANGING FROM GREATER THAN -15.0D TO -20.0D WITH LESS THAN OR EQUAL TO 2.5D OF ASTIGMATISM AT THE SPECTACLE PLANE; " AND THEREFORE THE SAFETY AND EFFECTIVENESS OF THE VISIAN ICL FOR THE CORRECTION OF MODERATE TO HIGH MYOPIA HAS NOT BEEN ESTABLISHED IN PATIENTS WITH GREATER THAN 2.5D OF ASTIGMATISM. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND THE MEDICAL REVIEW, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS IN HIS LEFT EYE (OS). THE PATIENT REPORTED HAD LIMBAL RELAXING INCISION DUE TO CORNEAL ASTIGMATISM. THE ICL WAS IMPLANTED ON (B)(6) 2012 AND REMAINS IMPLANTED. THE FACILITY INDICATED THE DATE OF THE LAST POST-OP VISIT WAS (B)(6)2013. THE DURATION OF THE EVENT WAS FROM (B)(6)2012 TO (B)(6) 2013 AND HAS BEEN RESOLVED. THE PROGNOSIS IS GOOD AND THE VA POST-OP TREATMENT WAS 20/20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582343 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY MICL13.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention