BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHAKIC6H 125

    MDR report key: 790883 · Received November 20, 2006

    Report

    Report Number
    2027748-2006-00001
    Event Type
    Malfunction
    Date Received
    November 20, 2006
    Report Date
    November 20, 2006
    Manufacturer
    OPHTHALMIC INNOVATIONS INTL., INC. (OII)
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LENS IS CURRENTLY NOT PMA APPROVED. THIS LENS IS NOT UNDER INVESTIGATION STUDY. THIS LENS IS CE MARKED AN IS ONLY SOLD INTERNATIONALLY. THIS LENS WAS ORIGINALLY SOLD TO A CUSTOMER IN ANOTHER COUNTRY.

    Description of Event or Problem · 1

    A WOMAN CALLED OII SAYING THAT HER HUSBAND WAS IMPLANTED WITH TWO PHAKIC6H 125 LENSES IN 2001. HE WAS EXPERIENCING VARIOUS PROBLEMS WITH HIS VISION WITH NO RELIEF OR DEFINITIVE EXPLANATION OF WHAT THE PROBLEM WAS. THEY OBTAINED A SECOND OPINION FROM A CORNEA EXPERT WHO FELT THE LENSES WERE CONTRIBUTING TO HIS CORNEAL EDEMA AND RECOMMENDED THAT THE LENSES BE REMOVED. THEY WERE ALSO TOLD THAT THE LENSES WERE NOT FDA APPROVED AND SHE WAS CALLING OII TO CONFIRM THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHAKIC6H 125 (HQL) ANTERIOR CHAMBER PHAKIC IOL HQL OPHTHALMIC INNOVATIONS INTL., INC. (OII) PHAKIC6H 125 6.0D 981218

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention