BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 1000483 · Received February 21, 2008

    Report

    Report Number
    2023826-2008-00213
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    January 21, 2008
    Report Date
    January 25, 2008
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THAT THERE WAS EVIDENCE OF A CLEAR SURGICAL RESIDUE, HOWEVER, THERE WAS NO VISIBLE DAMAGE TO THE LENS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON INSERTED CC4204BF COLLAMER PLATE LENS BEFORE DISCOVERING THE POSTERIOR CHAMBER WAS TORN. THE LENS WAS REMOVED AND AN ACL WAS IMPLANTED WITHOUT FURTHER INCIDENT. THIS FACILITY DOES NOT USE STAAR'S PHACOEMULSIFICATION EQUIPMENT. THE REPORTER STATED, THE INCIDENT WAS DUE TO A PRE-EXISTING PT CONDITION AND NOT RELATED TO THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL INTRAOCULAR LENS HQL STAAR SURGICAL CO. CC4204BF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention CARTRIDGE MODEL SFC-25 FP| FTP INDIGO MODEL| INJECTOR MODEL INDIGO-P