BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFPORT ADVANCED OPTIC LENS

    MDR report key: 3940432 · Received June 18, 2014

    Report

    Report Number
    1119279-2014-00140
    Event Type
    Injury
    Date Received
    June 18, 2014
    Report Date
    November 21, 2013
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DESPITE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFO, NO ADDITIONAL INFO HAS BEEN RECEIVED BY BAUSCH + LOMB TO DATE. A LENS WAS RETURNED FOR EVALUATION. OPTICAL MICROSCOPY IMAGES SHOWED A HAZE ON THE LENS SURFACE. THE 40X MAGNIFICATION SHOWED SMALL PARTICLES WHICH ARE FROM HANDLING OF THE MATERIAL AND ARE NOT ACTUAL DEPOSITS. SCANNING ELECTRON MICROSCOPE (SEM) MICROGRAPHS OBSERVED NO SIGNIFICANT DEPOSITS ON THE SURFACE OF THE LENS. SEM AND ENERGY DISPERSIVE SPECTROSCOPY (EDS) ANALYSIS FOUND NO EVIDENCE OF CALCIUM OR PHOSPHORUS ON THE SURFACE OR CROSS-SECTIONAL EDGE OF THE LENS. IN ADDITION, THE LENS UNDERWENT HEXANE EXTRACTION TO LOOK FOR ANY CHEMICAL SPECIES THAT MAY BE EXTRACTED FROM THE LENS. THE HEXANE EXTRACTION ANALYSIS WAS PERFORMED USING GC/MS. THE RESULTS WERE CONSISTENT WITH EXPECTED EXTRACTABLES FROM THE LENS MATERIAL. THE EXTRACTION ANALYSIS ALSO IDENTIFIED THE PRESENCE OF PROSPRAY (THE DISINFECTANT THAT WAS USED TO DECONTAMINATE THE LENS), AND A SUBSTANCE SIMILAR TO LIDOCAINE. OVERALL, THERE WAS NO SIGNIFICANT FINDING OF CALCIFICATION OR CHEMICAL DEPOSITS OBSERVED ON THE LENS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDING THAT RELATE TO THE REPORTED ISSUE. BASED ON THE CURRENT INFO, THE SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRAOCULAR LENS OPACIFIED 7 DAYS POST LENS IMPLANT. ADDITIONAL INFO HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357608 SOFPORT ADVANCED OPTIC LENS HQL/INTRAOCULAR LENS HQL BAUSCH & LOMB LI61AOR 4027311

    Patients

    Seq Age Sex Outcome Treatment
    1 Other