BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1870103 · Received October 5, 2010

    Report

    Report Number
    2023826-2010-00946
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    August 12, 2010
    Report Date
    September 20, 2010
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SECONDARY SURGERY. GLARE, UNSATISFACTORY VISION.

    Additional Manufacturer Narrative · 1

    THE PRODUCT FOR THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. THE WRONG LENS WAS RETURNED BY THE FACILITY. EVALUATION: METHOD: WORK ORDER SEARCH, MEDICAL REVIEW. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND. MEDICAL REVIEW - GLARE IS A SUBJECTIVE PERCEPTION OF STARBURSTS OF LIGHT (LIGHT AROUND OR COMING OFF OBJECTS/LIGHT SOURCES). USUALLY MORE DETECTABLE AT NIGHT TIME, BUT IT CAN ALSO BE DETECTED DURING DAYTIME. POTENTIAL CAUSES ARE: RESIDUAL REFRACTIVE ERRORS, OPTICAL ZONE OF THE TREATMENT/IMPLANT SMALLER THAN PREOPERATIVE PUPIL SIZE IN MESOPIC CONDITIONS, DECENTERED TREATMENT/IMPLANT, LIGHT FROM THE IRIDOTOMY SITES, ETC. USUALLY THE PERCEPTION OF GLARE IS TRANSIENT, ONLY RELATED TO SOME LIGHTING CONDITIONS AND DIMINISHES/DISAPPEARS OVER A COURSE OF WEEKS/MONTHS. IN SOME CASES, THE PERCEPTION MAY PERSIST AND BE SIGNIFICANT. IF THE PATIENT IS HAVING SIGNIFICANT DISTURBANCES AND IF THE IMPLANT IS THE SOURCE OF GLARE, IT CAN BE EXPLANTED THROUGH THE SAME INCISION. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND MEDICAL REVIEW, IT WAS DETERMINED AS THE LENS WAS IMPLANTED IN AN EYE WITH HISTORY OF AMBLYOPIA AND RETINAL DEGENERATION, THAT THIS CONSTITUTES AN OFF-LABEL USAGE OF THE DEVICE. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 11.5 MM ICM115V4 IMPLANTABLE COLLAMER LENS IN THE PT'S LEFT EYE (OS) ON (B)(6) 2010. THE LENS WAS EXPLANTED ON (B)(6) 2010 DUE TO PT COMPLAINING OF DISCOMFORT, UNSATISFACTORY VISION AND GLARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL CO. ICM115V4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention INJECTOR: MODEL MSI-PF, LOT NUMBER UNK| FOAM TIP PLUNGER: MODEL AND LOT NUMBER UNK| CARTRIDGE: MODEL SFC-45 FP, LOT NUMBER UNK