BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H-10

    MDR report key: 5304880 · Received December 16, 2015

    Report

    Report Number
    2023826-2015-01696
    Event Type
    Injury
    Date Received
    December 16, 2015
    Date of Event
    November 19, 2015
    Report Date
    November 20, 2015
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT PROBLEM AND EVALUATION CODES: RESULTS: (EVALUATION RESULT): VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE LENS OPTIC AND ONE HAPTIC TORN. THE LENS WAS RETURNED DRY AND THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. CONCLUSION: (UNABLE TO CONFIRM COMPLAINT): BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY RECORD REVIEW, MEDICAL REVIEW. RESULTS: UPON REVIEW OF THE DEVICE HISTORY RECORD, THERE IS NOTHING IN THE MANUFACTURING, INSPECTION AND PACKAGING PROCESS RECORDS THAT SUGGESTS A CONTRIBUTORY FACTOR IN THE COMPLAINT. REPORTEDLY, A SINGLE-PIECE SILICONE IOL WITH TORIC OPTIC WAS TORN UPON INSERTION REQUIRING INTRAOPERATIVE LENS REMOVAL/EXCHANGE. INCISION WAS ENLARGED AND ANOTHER LENS WAS SUCCESSFULLY IMPLANTED. THE SUTURE WAS PLACED FOR WOUND CLOSURE. NO REPORTED POSTOPERATIVE SEQUELAE. ACCORDING TO THE REPORT, BY A NURSE DATED ON (B)(6) 2015, THE CAUSE OF THE EVENT WAS UNKNOWN. CONCLUSION: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, PRODUCT EVALUATION, MEDICAL REVIEW, AND DEVICE HISTORY RECORD REVIEW, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT: SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS (ELASTIC®) WITH TORIC OPTIC. (B)(4). METHOD - (PROCESS EVALUATION): WORK ORDER SEARCH. RESULTS - (EVALUATION RESULT): A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. CONCLUSION - (UNABLE TO CONFIRM COMPLAINT): BASED ON THE COMPLAINT HISTORY AND WORK ORDER SEARCH, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED AN AA4203TL TORIC SILICONE SINGLE PIECE LENS, 18.0 SE/2.0 DIOPTER, AND THE LENS TORE. THE INCISION WAS ENLARGED TO REMOVE THE LENS DURING THE SAME SURGERY. THE BACKUP LENS WAS IMPLANTED AND A FIGURE 8 SUTURE WAS USED TO CLOSE THE INCISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829202 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AA4203TL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention