BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 4126805 · Received September 29, 2014

    Report

    Report Number
    2023826-2014-00762
    Event Type
    Malfunction
    Date Received
    September 29, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 29, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BRAND NAME: COLLAMER®ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS. (B)(4). RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED ONLY HALF OF THE OPTIC AND HALF OF ONE HAPTIC WAS RECEIVED THE REST OF THE LENS WAS TORN OFF AND MISSING. . A LENS WORK ORDER SEARCH WAS PERFORMED AND THERE WERE NO SIMILAR COMPLAINTS FOUND. CONCLUSION: BASED ON THE COMPLAINT HISTORY, PRODUCT EVALUATION AND LENS WORK ORDER SEARCH, WE WERE UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE OF THE EVENT. (B)(4).

    Additional Manufacturer Narrative · 1

    REPORTEDLY, HAPTIC OF THE SINGLE-PIECE COLLAMER IOL TORE OFF DURING INSERTION REQUIRING INTRAOPERATIVE LENS EXCHANGE. INCISION WAS NOT ENLARGED AND NO OTHER TISSUE DAMAGE WAS REPORTED. ANOTHER LENS OF SAME MODEL AND DIOPTER WAS SUCCESSFULLY IMPLANTED. NO REPORTED POSTOPERATIVE SEQUELAE. ACCORDING TO THE REPORT, BY A NURSE, DATED ON (B)(6) 2014, THE MOST LIKELY CAUSE OF THE EVENT WAS UNKNOWN. BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, MEDICAL REVIEW AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY REVIEW - DEVICE HISTORY RECORD REVIEW FOUND ASSOCIATED SOURCE LOTS WERE MANUFACTURED WITHIN ESTABLISHED PARAMETERS AND LIMITS. THIS IS A RESUBMISSION TO CORRECT THE MFR#. THE MFR NUMBER WAS REPORTED INCORRECTLY (MFR# 2023836-2014-00762). CLAIM# (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE HAPTIC OF THE +22.0 DIOPTER CC4204A COLLAMER SINGLE PIECE LENS TORE OFF ON INSERTION AND WAS REPLACED WITH ANOTHER STAAR LENS. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606689 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY CC4204A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR FTP INDIGO P, LOT NUMBER UNKNOWN| INDIGO-P INJECTOR, LOT NUMBER UNKNOWN