BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INRAOCULA

    MDR report key: 1923546 · Received December 1, 2010

    Report

    Report Number
    2023826-2010-01196
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 22, 2010
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), METHOD: LENS WORK ORDER SEARCH. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY AND WORK ORDER SEARCH, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS: PER 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. VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND NO VISIBLE DAMAGE TO THE LENS. THERE WAS EVIDENCE OF REDDISH RESIDUE. BOTH SIDES OF THE LENS OPTIC AND HAPTICS WERE CHECKED FOR ROUGH/SHARP EDGES AND WERE FOUND TO BE ACCEPTABLE. CONCLUSIONS: (NO CONCLUSION CAN BE DRAWN): 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.

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON INSERTED AND REMOVED AN AA4204VF SILICONE SINGLE PIECE LENS DUE TO A CAPSULE TEAR. A VITRECTOMY WAS PERFORMED AND A THREE PIECE LENS WAS IMPLANTED. THE REPORTER INDICATED THE FACILITY USES A COMPETITOR'S PHACOEMULSIFICATION SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INRAOCULA INTRAOCULAR LENS HQL STAAR SURGICAL CO. AA4204VF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention CARTRIDGE: MODEL MTC-60C FP, LOT NUMBER - UNK| INJECTOR: MODEL UNK, LOT NUMBER - UNK