BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 4246658 · Received November 12, 2014

    Report

    Report Number
    2023826-2014-00971
    Event Type
    Malfunction
    Date Received
    November 12, 2014
    Date of Event
    June 17, 2014
    Report Date
    October 16, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BRAND NAME: COLLAMER®ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS. (B)(4). METHOD: LENS WORK ORDER SEARCH. RESULTS: A PARENT/CHILD LENS WORK ORDER SEARCH REVEALED THERE WERE NO SIMILAR COMPLAINTS FOUND WITHIN THE WORK ORDER. CONCLUSION: (UNABLE TO CONFIRM): BASED ON THE COMPLAINT HISTORY, LENS WORK ORDER SEARCH AND PRODUCT EVALUATION, WE WERE UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE OF THE EVENT. (B)(4).

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION OF THE RETURNED LENS SHOWED THAT THE HAPTIC AND HALF OF THE OPTIC WERE TORN OFF AND MISSING. PER MEDICAL REVIEW - REPORTEDLY, INTRAOPERATIVE SINGLE-PIECE COLLAMER IOL EXCHANGE WAS PERFORMED TO ADDRESS LENS DAMAGE ("TORE AS IT WAS INSERTED IN THE EYE"). INCISION WAS NOT ENLARGED AND NO OTHER TISSUE DAMAGE WAS REPORTED. ANOTHER LENS OF SAME MODEL WAS IMPLANTED SUCCESSFULLY. NO REPORTED POSTOPERATIVE SEQUELAE. ACCORDING TO THE COMPLAINT DESCRIPTION THE MOST LIKELY CAUSE OF THE EVENT WAS UNKNOWN. BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, PRODUCT EVALUATION, AND MEDICAL REVIEW, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE FOLLOWING STATEMENT SHOULD HAVE BEEN ADDED IN SUPPLEMENTAL #2: DEVICE HISTORY RECORD (DHR) REVIEW: REVIEW OF THE MANUFACTURING, INSPECTION, AND PACKAGING PROCESS CONCLUDED THERE WAS NOTHING FOUND TO SUGGEST A CONTRIBUTORY FACTOR TO THIS COMPLAINT. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: THIS IS A RE-SUBMISSION OF MFR# 2023836-2014-00971 DUE TO PREVIOUS INCORRECT MFR#. CLAIM# (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE CC4204A +19.0 DIOPTER COLLAMER SINGLE PIECE LENS TORE AS IT WAS INSERTED INTO THE EYE. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER SAME MODEL/DIOPTER LENS WITHOUT ANY PATIENT INJURY. THE WAS ALL THE INFORMATION THE CUSTOMER HAD ON THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730867 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY CC4204A NA

    Patients

    Seq Age Sex Outcome Treatment
    1