BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 3010257 · Received March 12, 2013

    Report

    Report Number
    1119421-2013-00257
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    January 1, 2013
    Report Date
    February 11, 2013
    Manufacturer
    ALCON RESEARCH, LTD/HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE WERE NO OTHER COMPLAINTS REPORTED FOR THIS LOT. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT FOLLOWING BILATERAL INTRAOCULAR LENS IMPLANT SURGERIES, HER DISTANCE VISION WAS WORSE THAN PRIOR TO SURGERY. SHE ALSO REPORTED SEEING HALOS AND "HEADLIGHTS ARE BLINDING". SHE IS NOT COMFORTABLE DRIVING AT NIGHT. SHE REPORTED THAT SHE CANNOT READ STREET SIGNS OR OVERHEAD SIGNS AT THE GROCERY STORE. HER NEAR VISION IS GOOD, BUT DISTANCE VISION IS BLURRED. THE CONSUMER SPOKE TO HER SURGEON AND HE TOLD HER "IT WAS TOO EARLY AND SHE SHOULD GIVE IT MORE TIME". SHE ALSO REPORTED THAT SHE HAS HAD MULTIPLE CONDUCTIVE KERATOPLASTY (CK) PROCEDURES DONE ON HER LEFT EYE IN THE PAST, PRIOR TO IMPLANT SURGERY. ADD'L INFO WAS RECEIVED FROM THE SURGEON, WHO INDICATED THE PT DID NOT USE POST OPERATIVE MEDICATIONS AS PRESCRIBED. IN HIS OPINION, THE IOL DID NOT CAUSE THE EVENT. DURING A F/U WITH THE SURGEON, HE INDICATED THAT HE EXPLAINED TO THE PT THAT THE PREVIOUS CK PROCEDURES, COULD "THROW OFF" THE IOL MEASUREMENTS TAKEN PRIOR TO IMPLANT SURGERY. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104319 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD/HUNTINGTON SN60WF 12162904

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other PROVISC| VISCOAT