BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1833637 · Received September 8, 2010

    Report

    Report Number
    2023826-2010-00891
    Event Type
    Injury
    Date Received
    September 8, 2010
    Date of Event
    May 11, 2010
    Report Date
    August 9, 2010
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL RESULTS - VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND NO VISIBLE DAMAGE TO LENS. THERE WAS EVIDENCE OF REDDISH RESIDUE ON LENS SURFACE. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY AND EVAL OF THE RETURNED PRODUCT, THE ROOT CAUSE OF THE EVENT HAS BEEN DETERMINED TO BE DUE TO A PT RELATED CONDITION AND WAS NOT LENS RELATED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED, THE SURGEON INSERTED AN AQ2010V THREE PIECE SILICONE LENS TO REPLACE A PMMA LENS IMPLANTED THIRTY YEARS AGO. VITRECTOMY WAS PERFORMED AFTER PMMA LENS WAS REMOVED AND PRIOR TO AQ2010V LENS INSERTION. AFTER LENS WAS INSERTED, FOUND LENS TO BE DECENTERED DUE TO INADEQUATE CAPSULAR SUPPORT. LENS WAS REMOVED IN ONE PIECE AND DECISION WAS MADE TO IMPLANT A ANTERIOR CHAMBER LENS. THREE SUTURES WERE REQUIRED TO CLOSE THE SUPEROTEMPORAL CORNEAL INCISION. NO SUTURE WAS NEEDED TO CLOSE THE SCLEROTOMY SITE. REPORTER STATED INCIDENT WAS DUE TO PT RELATED CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA INTRAOCULAR LENS HQL STAAR SURGICAL CO. AQ2010V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention INJECTOR MODEL - MSI-TM - LOT # UNK| CARTRIDGE MODEL - AQ CARTRIDGE-FP - LOT # UNK