BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 2100701 · Received May 18, 2011

    Report

    Report Number
    2023826-2011-00426
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 20, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), OTHER, LENS TORE POSTERIOR. METHOD: (OTHER) LENS WORK ORDER SEARCH. RESULTS: (OTHER) VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THE LENS WAS RETURNED IN LIQUID, THERE WERE TEARS IN THE LENS AND A PIECE OF BOTH THE OPTIC AND A HAPTIC WAS TORN OFF AND MISSING. A WORK ORDER SEARCH PERFORMED AND THERE WERE NO SIMILAR COMPLAINTS FOUND. CONCLUSION: (NO CONCLUSION CAN BE DRAWN). BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND PRODUCT EVALUATION, WE WERE UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE OF THE EVENT. (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS: A CAPSULE TEAR IS LIKELY SECONDARY TO SURGICAL MANIPULATION BY THE SURGEON RATHER THAN THE LENS ITSELF, HOWEVER, IT REMAINS UNCLEAR WHETHER THE PRODUCT CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    THE REPORTER STATED AFTER THE (B)(4) COLLAMER PLATE LENS WAS INSERTED, THE POSTERIOR CAPSULE TORE AND THE LENS STARTED TO GO BEHIND THE EYE. THE LENS WAS CUT OUT OF THE EYE IMMEDIATELY AND A SULCUS LENS WAS IMPLANTED. THE INCISION WAS NOT ENLARGED OR SUTURED AND NO VITRECTOMY PERFORMED. PT IS DOING FINE NOW. THE REPORTER STATED THE ANATOMY OF THE EYE WAS IN GOOD CONDITION PRIOR TO THE SURGERY, THEREFORE, THE SURGEON BELIEVES THE INCIDENT WAS CAUSED BY THE LENS.

    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 COMPANY CC4204A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Required Intervention NANOPOINT CARTRIDGE: LOT NUMBER UNKNOWN| NANOPOINT INJECTOR: LOT NUMBER UNKNOWN| NANOPOINT INJECTOR: LOT NUMBER UNK| NANOPOINT CARTRIDGE: LOT NUMBER UNK