BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H-10

    MDR report key: 2152720 · Received July 7, 2011

    Report

    Report Number
    2023826-2011-00605
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    May 26, 2011
    Report Date
    June 9, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS (ELASTIC). (B)(4). EVALUATION: RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED EVIDENCE OF A CLEAR SURGICAL RESIDUE, HOWEVER, THERE WAS NO VISIBLE DAMAGE TO THE LENS. BOTH SIDES OF THE OPTIC/HAPTICS WERE CHECKED FOR ROUGH/SHARP EDGES AND EDGES WERE FOUND TO BE ACCEPTABLE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL REVIEW - A CAPSULE TEAR IS LIKELY SECONDARY TO SURGICAL MANIPULATION BY THE SURGEON RATHER THAN THE LENS ITSELF, HOWEVER, IT REMAINS UNCLEAR WHETHER THE PRODUCT CAUSED OR CONTRIBUTED TO THIS EVENT. (B)(4)

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD - DEVICE HISTORY REVIEW. RESULTS: AFTER REVIEWING THE COMPLAINT FILE, DEVICE HISTORY RECORD AND PERFORMING A ROOT CAUSE ANALYSIS, THERE IS NO DIRECT EVIDENCE THAT LEADS TO THE ROOT CAUSE OF THIS COMPLAINT. THE ROOT CAUSE IS NOT LIKELY RELATED TO THE MANUFACTURING PROCESS OF THE LENS. A POSTERIOR CAPSULE TEAR IS MORE COMMONLY SECONDARY TO SURGICAL MANIPULATIONS PERFORMED BY THE SURGEON DURING INTRAOCULAR SURGERY. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE (B)(4) SILICONE SINGLE PIECE LENS WAS INSERTED AND REMOVED DUE TO A CAPSULE TEAR. REPLACED WITH ANOTHER STAAR LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED. IF ADDITIONAL INFORMATION IS OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AA4203TL N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR