BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 2103775 · Received May 24, 2011

    Report

    Report Number
    2023826-2011-00425
    Event Type
    Injury
    Date Received
    May 24, 2011
    Date of Event
    March 18, 2011
    Report Date
    May 11, 2011
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION METHOD: LENS WORK ORDER SEARCH, MEDICAL REVIEW. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINT WAS FOUND WITHIN THE SAME WORK ORDER. MEDICAL REVIEW: A POSTERIOR CAPSULE TEAR IS MORE COMMONLY SECONDARY TO SURGICAL MANIPULATIONS PERFORMED BY THE SURGEON DURING INTRAOCULAR SURGERY HOWEVER, IT REMAINS UNCLEAR WHETHER THE PRODUCT CAUSED OR CONTRIBUTED TO THIS EVENT. VITRECTOMY IS CONSEQUENTLY PERFORMED IN THE PRESENCE OF A CAPSULE TEAR WHERE THERE IS VITREOUS LOSS, TO PRECLUDE ANY FURTHER INJURY. ENLARGEMENT OF AN INCISION COMBINED WITH SUTURING MAY CAUSE INDUCED ASTIGMATISM, HOWEVER, IT IS DEPENDENT ON THE LENGTH OF THE INCISION AS WELL AS THE TIGHTNESS OF THE SUTURE. WHEN A LENS IS REMOVED, INCISION IS USUALLY ENLARGED TO A LENGTH THAT WOULD NOT CREATE ANY SERIOUS INJURY AND SUTURE IS PLACED, ONLY TO SECURE THE WOUND. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, MEDICAL REVIEW AND WORK ORDER SEARCH, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTED STATED THE SURGEON INSERTED A CC4204A COLLAMER ASPHERIC SINGLE PLATE LENS. THE SURGEON NOTICED CAPSULE TEAR AFTER LENS INSERTION. THE INCISION WAS ENLARGED TO REMOVE THE LENS. A VITRECTOMY WAS PERFORMED. A COMPETITOR'S LENS WAS IMPLANTED. A SUTURE WAS USED TO CLOSE THE WOUND. LENS WAS DISCARDED.

    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. CC4204A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INJECTOR SYSTEM: MODEL - NANOPOINT, LOT NUMBER UNK