BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CEEON MODEL 811A LENS

    MDR report key: 94668 · Received May 30, 1997

    Report

    Report Number
    57701-1997-00016
    Event Type
    Injury
    Date Received
    May 30, 1997
    Date of Event
    April 8, 1997
    Report Date
    April 29, 1997
    Manufacturer
    PHARMACIA PRODUCTION B.V.
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A NURSE CALLED FROM AN OUTPATIENT SURGICAL CENTER TO REPORT THAT A FEMALE PATIENT HAD A CEEON MODEL 811A/20.5 D LENS REMOVED BECAUSE IT HAD DECENTERED. THE SURGEON HAD TOLD THE NURSE THAT THE PATIENT HAD SURGICALLY INDUCED MYOPIA THAT COULD BE RELATED TO THE EXPLANTED LENS. THE LENS WAS REPLACED WITH ANOTHER THAT WAS 19.0 DIOPTER. PHARMACIA & UPJOHN WILL BE CONDUCTING A BATCH REVIEW OF THIS LENS AS WELL AS EVALUATING THE EXPLANTED LENS ONCE IT IS RETURNED TO CO. FOLLOW UP INFO RECEIVED FROM TEH IMPLANTING SURGEON ON 5/21/97 INDICATED THAT THE WOMAN MADE A FULL RECOVERY. HE FIRST DISCOVERED THE LENS WAS DECENTERED ON 4/8/97. HE WROTE HE DID NOT THINK THE EVENT WAS LENS RELATED. THE WOMAN DEVELOPVED A FIBROTIC TRACTION BAND BETWEEN THE NASAL ANTERIOR AND POST CAPSULE LEAFLETS AND THIS INDUCED A PEAPOD EFFECT. THE TREATMENT REQUIRED WAS A LENS EXCHANGE AND POWER REDUCTION. THE RETURNED LENS HAS BEEN SENT TO MFG SITE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CEEON MODEL 811A LENS Implant 1 PIECE PMMA CAP C DESIGN HQL PHARMACIA PRODUCTION B.V. 811A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other| R