BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEE ON AV ABSORBING SILICONE LENS

    MDR report key: 58290 · Received October 4, 1996

    Report

    Report Number
    2083358-1996-00005
    Event Type
    Malfunction
    Date Received
    October 4, 1996
    Date of Event
    August 1, 1996
    Report Date
    October 4, 1996
    Manufacturer
    PHARMACIA IOVISION INC
    Product Code
    HOL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON 12/6/96: DURING A FOLLOW-UP CONVERSATION WITH SALES REPRESENTATIVE TO OBTAIN THE INTRAOCULAR LENS'S FOR EVALUATION, HE INDICATED THAT ONLY ONE INTRAOCULAR LENS WAS RETURNED TO HIM AND HE HAD FORWARDED THE LENS TO CO'S CLAYTON FACILITY FOR EVALUATION. HE REPORTED THAT THE OTHER LENS WAS IMPLANTED INTO A PT'S LEFT EYE. HOWEVER, THE PHYSICIAN DENIED IMPLANTATION OF ANY CRACKED LENSES AND HIS OFFFICE NURSE AND SURGERY REPORTED THAT THEY HAD RETURNED BOTH LENSES TO THE SALES REPRESENTATIVE TO RETURN TO QA FOR EVALUATION. CORPORATE PHARMACOVIGILANCE HAS REPORTED THE CRACKED LENS ACCORDING TO THE PHYSCIAN STORY AS BOTH THE PHYSCIAN'S OFFICE AND OTHER PERSONNEL MAINTAINED THROUGHOUT THE FOLLOW-UP PROCESS THAT THE LENS HAD NOT BEEN IMPLANTED AND RETURNED VIA THE SALES REPRESENTATIVE FOR EVALUATION. ON 01/06/97, IT WAS REPORTED FROM CO'S CLAYTON FACILITY THAT ONE LENS WAS RECEIVED FOR EVALUATION. IT WAS PLACED UNDER A MICROSCOPE AND THERE WAS NO EVIDENCE OF PT CONTACT AND THERE WAS NO VISIBLE CRACK IN THE OPTIC. NO FURTER INFORMATION IS EXPECTED.

    Description of Event or Problem · 1

    INITIALLY, THIS REPORT WAS RECEIVED FROM A SALES REP OF AN OPHTHALMOLOGIST WHO REPORTED CRACKING OF THE INTRAOCULAR LENS SUBSEQUENTLY THE OPHTHALMOLOGIST FORWARDED A LETTER TO CO STATING THAT WHILE FOLDING THE LENS PRIOR TO INSERTION, THE LENS SPLIT WITH A CRACK INVOLVING THE CENTER OF THE LENS. THE LENS WAS NOT IMPLANTED THE OPHTHALMOLOGIST INDICATED THAT THE LENS WAS THICK AND HE HAS HAD "SEVERAL" THAT HAVE CRACKED. HE BELIEVED THE PRODUCT TO BE DIFFICULT TO WORK WITH AND THE LENS WAS NOT MEETING HIS EXPECTATIONS. HE INDICATED THAT HE HAS USED THE SAME TECHNIQUE FOR MANY LENS IMPLANTS. HE USED A MCPHERSON ANGLED FORCEP AND LOCKING INSERTER. BOTH LENSES WERE FROM THE SAME BATCH. ADDITIONAL INFORMATION IS BEING SOUGHT FROM THE MD. CO IS ATTEMPTING TO OBTAIN THE LENSES FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CEE ON AV ABSORBING SILICONE LENS Implant INTRAOCULAR LENS HOL PHARMACIA IOVISION INC 920 000006882

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other