BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 2010958 · Received March 4, 2011

    Report

    Report Number
    2031924-2011-00051
    Event Type
    Injury
    Date Received
    March 4, 2011
    Report Date
    February 2, 2011
    Manufacturer
    BAUSCH + LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS IS IMPLANTED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED ISSUE.

    Description of Event or Problem · 1

    BAUSCH + LOMB RECEIVED A COMPLAINT FROM A CONSUMER WHO IS DISSATISFIED WITH VISUAL OUTCOME AFTER IMPLANTATION OF CRYSTALENS INTRAOCULAR LENSES IN BOTH EYES. THIS REPORT REFERS TO THE RIGHT EYE. THE PATIENT EXPERIENCED POOR INTERMEDIATE AND NEAR VISION IN THE RIGHT EYE POSTOPERATIVELY. ALSO, THE PATIENT REPORTS HAVING BEEN PRESCRIBED TOPICAL STEROIDAL/NSAID DROPS TO TREAT SUSPECTED RETINAL EDEMA. ADDITIONAL INFORMATION RECEIVED FROM THE SURGEON INDICATES THAT THE IOL IS FREE OF DEBRIS/DEPOSITS, AND THERE WERE NO COMPLICATIONS OF THE ORIGINAL SURGICAL PROCEDURE. ALSO, THE PATIENT UNDERWENT YAG LASER CAPSULOTOMY FOR THE RIGHT EYE. PREOPERATIVELY, THE PATIENT'S BCVA WAS 20/25 WITH MR OF -5.00 -0.50 X080. POSTOPERATIVELY, THE PATIENT'S BEST CORRECTED VISUAL ACUITY IS 20/20 WITH MR OF PLANO +0.50 X 90. REFERENCE MDR # 2031924-2011-00050.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS NAA BAUSCH + LOMB AT52AO 019237

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other