BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-FOCAL HYBRID CONTACT LENS

    MDR report key: 2653467 · Received December 31, 2009

    Report

    Report Number
    3005087645-2009-00004
    Event Type
    Injury
    Date Received
    December 31, 2009
    Report Date
    December 13, 2009
    Manufacturer
    SYNERGEYES, INC.
    Product Code
    HQD
    PMA / PMN Number
    K051035/5001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO LENS WAS RETURNED TO THE COMPANY. BASED ON THE LIMITED AMOUNT OF INFO PROVIDED BY THE PRACTITIONER, IT IS BELIEVED THAT USER ERROR WAS THE ROOT CAUSE FOR THIS CASE OF CORNEAL ABRASION. THE PRACTITIONER'S OFFICE STATED THAT THE PT KEPT GETTING CORNEAL ABRASIONS UPON REMOVAL OF THE LENS. THERE WAS USER ERROR BY BOTH THE PRACTITIONER (IMPROPER FIT OF THE LENS, CAUSING DIFFICULT REMOVAL) AND THE PT (IMPROPER REMOVAL TECHNIQUE). THE PRACTIONER WILL BE CONTACTED TO DISCUSS PROPER LENS FITTING METHODOLOGY AND PT INSTRUCTIONS FOR USE. NO DEVICE HISTORY RECORD COULD BE REVIEWED BECAUSE NO SPECIFIC LOT NUMBER WAS REPORTED FOR THE EVENT.

    Description of Event or Problem · 1

    THE PRACTITIONER'S OFFICE "CLAIMS THE PT KEEPS GETTING CORNEAL ABRASION WHEN SHE TRIES TO REMOVE THE LENSES" FROM AN E-MAIL DATED (B)(6) 2009. A COMPLAINT FOLLOW-UP FORM WAS FAXED, REFAXED, AND FEDEX'D TO THE PRACTITIONER'S OFFICE. FINALLY, A RESPONSE WAS MAILED BACK TO THE COMPANY WITH THE DATE OF (B)(4) 2009 BY (B)(6). THE PRACTIONER STATED THAT PT "SCRATCHED OS CORNEA UPON REMOVAL OF LENS." THE PRACTICE TRIED TO RETURN THE LENS BUT WAS UNABLE TO. THE PT'S RECOVERY WAS DESCRIBED AS "CURRENTLY SHE IS 20/40 BEST CORRECTED AND UNDERGOING CARE WITH A CORNEAL SPECIALIST."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-FOCAL HYBRID CONTACT LENS CONTACT LENS HQD SYNERGEYES, INC. M-MULTI-FOCAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention