BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 2963373 · Received February 13, 2013

    Report

    Report Number
    2023826-2013-00119
    Event Type
    Injury
    Date Received
    February 13, 2013
    Date of Event
    December 20, 2012
    Report Date
    January 18, 2013
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: LENS WORK ORDER SEARCH, MEDICAL REVIEW. RESULT, OTHER: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE OPTIC IS TORN. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINT WAS FOUND WITHIN THE SAME WORK ORDER. MEDICAL REVIEW - REVIEW OF THIS FILE INDICATES THAT THE PT WAS IMPLANTED WITH A +1.0D IOL ON (B)(6) 2012 AND EXCHANGED WITH A +3.0D IOL ON (B)(6) 2012 DUE TO REFRACTIVE ERROR. THE SURGEON INDICATED THAT THE EVENT WAS NOT DUE TO THE IOL AND NO OTHER ADVERSE EVENTS OCCURRED. THE MOST LIKELY ROOT CAUSE OF THIS EVENT IS EITHER MISCALCULATION OR MISMEASUREMENT. CONCLUSION : BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, MEDICAL REVIEW AND THE EVAL OF THE RETURNED PRODUCT, IT WAS DETERMINED THAT MOST LIKELY THE ROOT CAUSE OF THIS EVENT WAS MISCALCULATION OR MISMEASUREMENT. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON IMPLANTED AN AQ5010V THREE PIECE SILICONE LENS IN THE PT'S RIGHT EYE ON (B)(6) 2012. LENS WAS REMOVED ON (B)(6) 2012 DUE TO REFRACTIVE AIM WAS NOT ACHIEVED. THE PRIMARY LENS A +01.00 WAS EXCHANGED WITH A -03.00 DIOPTER LENS. THE REPORTER STATED THIS EVENT WAS NOT DUE TO THE LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63874 SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA INTRAOCULAR LENS HQL STAAR SURGICAL CO. AQ5010V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention INJECTOR - MODEL & LOT # UNK| CARTRIDGE - MODEL & LOT # UNK