BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2202076 · Received August 5, 2011

    Report

    Report Number
    9612169-2011-00043
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 11, 2011
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: PRODUCT EVAL: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE LENS MET RELEASE CRITERIA. UNABLE TO REVIEW LOT AND BATCH RECORDS FOR THE CARTRIDGE BECAUSE THE FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. THE COMPLAINANT INDICATED THE USE OF A CARTRIDGE AND VISCOELASTIC WHICH ARE NOT APPROVED FOR USE WITH THE ASSOCIATED LENS MODEL. ROOT CAUSE: THE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED AS NO PRODUCT WAS RETURNED FOR ANALYSIS. BASED ON THE RESULTS FROM THE PRODUCT AND BATCH HISTORY RECORD, THE PRODUCT MET RELEASE CRITERIA. IN ADDITION, THE SURGEON STATES THE USE OF AN UNAPPROVED VISCOELASTIC FAILING TO FOLLOW THE DFU. ACTIONS: THERE HAVE BEEN NO OTHER COMPLAINTS FOR THIS LOT. NO FURTHER ACTION IS WARRANTED AT THIS TIME. ADD'L INFO WAS REQUESTED ON (B)(4) 2011. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON (B)(4) 2011. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMIC SURGEON REPORTED AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. HE STATED THE IOL WAS EXPLANTED AND REPLACED WITH THE SAME MODEL IOL. ON (B)(6) 2011, ADD'L INFO WAS RECEIVED FROM THE SURGEON REPORTING POST EXCHANGE THE PT IS EXPERIENCING SEVERE CORNEAL EDEMA. HE STATED AT THIS TIME THE PT'S SYMPTOMS HAVE NOT RESOLVED AND IT IS UNK WHAT CAUSED OR CONTRIBUTED TO THE EVENT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE EXCHANGED IOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60AT 21011921

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention PROVISC