BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 3201700 · Received June 28, 2013

    Report

    Report Number
    2023826-2013-00535
    Event Type
    Injury
    Date Received
    June 28, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 6, 2013
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: LENS WORK ORDER SEARCH. RESULT - A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINT WAS FOUND WITHIN THE SAME WORK ORDER. #(B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: A VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE OPTIC TORN IN TWO PIECES. LENS WAS RETURNED DRY. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE ON PRODUCT. CONCLUSIONS: (NO CONCLUSION CAN BE DRAWN) - BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    RESULTS - DEVICE HISTORY REVIEW: AFTER A REVIEW OF THE DEVICE HISTORY RECORD, IT HAS BEEN DETERMINED THAT NOTHING IN THE MANUFACTURING PROCESS CAN BE IDENTIFIED AS THE ROOT CAUSE OF THIS COMPLAINT. IT IS UNCLEAR IF THE LENS ITSELF CAUSED OR CONTRIBUTED TO THE ONSET OF IRITIS. THEREFORE, NO ROOT CAUSE CAN BE IDENTIFIED. PROBABLE CAUSES FOR THIS EVENT INCLUDE PRE-EXISTING PATIENT ISSUES OR CONDITIONS. CONCLUSIONS - (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, DEVICE HISTORY REVIEW AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    MEDICAL REVIEW: OS: REPORTEDLY THREE-PIECE SILICONE LENS WAS EXPLANTED TWO MONTHS POSTOPERATIVELY TO ADDRESS DEVELOPMENT OF SEVERE IRITIS AND ELEVATED IOP (PRESUMABLE DUE TO PRESCRIBED STEROID TREATMENT FOR IRITIS- PRED FORTE). IT SHOULD BE NOTED THAT STAAR LENS WAS USED AS PIGGYBACK LENS FOR CORRECTION OF RESIDUAL REFRACTIVE ERROR, AND THAT IS OFF- LABEL USE PER DFU INDICATIONS:" THE SILICONE 3P IOLS ARE INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN PERSONS 60 YEARS OF AGE OR OLDER IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED BY EXTRA-CAPSULAR CATARACT EXTRACTION. THESE DEVICES ARE INTENDED TO BE PLACED IN THE CILIARY SULCUS OR CAPSULAR BAG." IT SHOULD BE NOTED THAT PATIENT FACTOR (COMPLICATED OCULAR HISTORY) WAS THE MOST LIKELY CAUSE OF THE EVENT. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, LENS WORK ORDER SEARCH, DEVICE HISTORY REVIEW, MEDICAL REVIEW AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON IMPLANTED AN AQ5010V THREE PIECE SILICONE LENS IN THE PT'S LEFT EYE ON (B)(6) 2013. THE LENS WAS IMPLANTED AS A PIGGY-BACK LENS. THE PT DEVELOPED SEVERE IRITIS, HAD ELEVATED PRESSURE AND WAS TAKING FORTE MEDICATION TO LOWER PRESSURE. PT DID NOT HAVE ANY PRE-EXISTING CONDITIONS. THE LENS WAS EXPLANTED ON (B)(6) 2013. A SUTURE USED TO CLOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296970 SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA INTRAOCULAR LENS HQL STAAR SURGICAL CO. AQ5010V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CARTRIDGE, MODEL AND LOT #UNK| INJECTOR, MODEL AND LOT # UNK