BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 1911713 · Received November 16, 2010

    Report

    Report Number
    2023826-2010-01148
    Event Type
    Injury
    Date Received
    November 16, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 20, 2010
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (NO PRODUCT ALLEGATION): NO LENS IN UNIT CARTON. EVALUATION: CONCLUSION: BASED ON THE COMPLAINT HISTORY, THE ROOT CAUSE OF THE EVENT IS A PRE-EXISTING PATIENT CONDITION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON INSERTED AN AA4203TL SILICONE PLATE LENS AND THE PATIENT'S POSTERIOR CAPSULE COLLAPSED. THE LENS WAS REMOVED, A VITRECTOMY WAS PERFORMED AND AN ACL WAS IMPLANTED. SUTURES WERE REQUIRED. THE REPORTER STATED THE INCIDENT WAS CAUSED BY THE PATIENT'S PRE-EXISTING WEAK ZONULES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL INTRAOCULAR LENS HQL STAAR SURGICAL CO. AA4203TL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INJECTOR: MODEL UNK, LOT NUMBER UNK| CARTRIDGE: MODEL UNK, LOT NUMBER UNK