BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CEE-ON LENS

    MDR report key: 87365 · Received April 25, 1997

    Report

    Report Number
    57701-1997-00011
    Event Type
    Injury
    Date Received
    April 25, 1997
    Date of Event
    December 19, 1996
    Report Date
    March 21, 1997
    Manufacturer
    PHARMACIA PRODUCTION B.V.
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CO RECEIVED A REPORT FROM A PHYSICIAN WHO RETURNED A MODEL 812B / 23.0 (D) THAT HAD BEEN EXPLANTED BECAUSE THE DIOPTER AFTER SURGERY WAS -5.75 WHEN THE DESIRED RESULT WAS -2.50. HE QUESTIONED WHETHER THE ORIGINAL POWER ON THE LENS WAS ACCURATE. THE WOMAN HAD A CATARACT EXTRACTION AND IMPLANTATION OF THE LENS ON 28AUG96. THE LENS WAS EXPLANTED AND REPLACED ON 19DEC96 BECAUSE OF THE SUSPECTED DIOPTER ERROR. THE LENS WAS RETURNED AND REMEASURED FOR DIOPTER AND A BATCH & LOT REVIEW COMPLETED BY THE MFR. THE DIOPTER MEASUREMENT WAS FOUND TO BE WITHIN SPECIFICATIONS. BATCH RECORDS WERE REVIEWED AND FOUND TO BE WITHIN SPECIFICATIONS. NO PRODUCTION RELATED CAUSES COULD BE IDENTIFIED. ADDITIONAL INFORMATION IS BEING SOUGHT FROM THE TREATING OPHTHALMOLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CEE-ON LENS Implant 1 PIECE PMMA CAP C DESIGN HQL PHARMACIA PRODUCTION B.V. 812B /23.0(D) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention