BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOFOCAL IOLS

    MDR report key: 2621724 · Received June 19, 2012

    Report

    Report Number
    2648035-2012-00149
    Event Type
    Injury
    Date Received
    June 19, 2012
    Date of Event
    May 1, 2012
    Report Date
    May 20, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: DIABETES, BRAND NAME: PHACOFLEX II, COMMON DEVICE NAME: HQL-MONOFOCAL IOL. MODEL # S130NB, CATALOG # S130NB, SERIAL # (B)(4), EXPIRATION DATE = 06/30/1999, IMPLANT DATE: 09/19/1994, DEVICE MFR DATE: 06/01/1994, PMA# = P880081. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. SHOULD NEW INFORMATION BE RECEIVED THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT, ANOTHER SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    BECAUSE THE MODEL AND SERIAL NUMBER OF THE LENS IS UNKNOWN, THE SPECIFIC INFORMATION OF BRAND, TYPE, MODEL, SERIAL NUMBER, 510(K) NUMBER, MANUFACTURE AND EXPIRATION DATES CANNOT BE IDENTIFIED AT THIS TIME. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. SHOULD NEW INFORMATION BE RECEIVED THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED DUE TO CALCIFICATION AND THE PATIENT'S REPORT OF BLURRED VISION. FOLLOW UP WITH THE REPORTING PHYSICIAN'S OFFICE INDICATES THAT THE PATIENT REQUIRED AN ANTERIOR VITRECTOMY ATTRIBUTED TO HIS ANATOMY AND NOT RELATED TO THE ABBOTT MEDICAL OPTICS (AMO) LENS. THE PATIENT IS REPORTED TO BE DOING FINE. FOLLOW-UP WITH THE PHYSICIAN INDICATED THAT THE LENS IS BELIEVED TO BE A SILICONE LENS; HOWEVER, THE MODEL AND SERIAL NUMBER IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention