BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD 1% OVD

    MDR report key: 2839023 · Received October 28, 2010

    Report

    Report Number
    3000164186-2010-00002
    Event Type
    Other
    Date Received
    October 28, 2010
    Date of Event
    July 13, 2010
    Report Date
    October 20, 2010
    Manufacturer
    BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
    Product Code
    LZP
    PMA / PMN Number
    P960011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP INFORMATION WAS RECEIVED ON (B)(6) 2012 FROM THE DISTRIBUTOR. ON (B)(6) 2010, THE DISTRIBUTOR FOUND THAT THE NATURE OF THE INITIAL INVESTIGATION INFORMATION WAS FALSE. THE FINGER GRIP DID NOT RUB THE EPITHELIUM; THE OPERATING PHYSICIAN CONFIRMED THAT THE CANNULA HIT THE CORNEAL ENDOTHELIUM. THE PATIENT VISION WAS STATED TO BE GOOD, HOWEVER A SMALL CLOUDY AREA IN THE VISION PERSISTED, WHICH LED TO REFERRAL TO A SPECIALIST. THE PATIENT DID NOT HAVE DSAEK SURGERY BUT WAS REFERRED TO A CORNEAL SPECIALIST WHO PLACED AN AIR BUBBLE IN THE ANTERIOR CHAMBER TO FORCE RE-ATTACHMENT OF DESCEMETS. THE PROCEDURE WAS SUCCESSFUL AND AS OF (B)(6) 2010 THE PATIENT WAS 20/20 WITH A CLEAR CORNEA. FURTHER INFORMATION HAS BEEN REQUESTED. IF NEW SIGNIFICANT DATA IS RECEIVED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS CASE IS CROSS-REFERENCED TO US MW MFR REPORT #(B)(4) FILED BY (B)(6) ON (B)(6) 2010. ON (B)(6) 2010, THE MANUFACTURER (BTG) RECEIVED INFORMATION THAT A PATIENT WAS INJURED DURING USE OF THE PRODUCT. THIS SERIOUS SPONTANEOUS REPORT WAS RECEIVED AT THE MANUFACTURER AS A COMPLAINT FROM A UNITED STATES OPERATING ROOM SUPERVISOR VIA A SALES DISTRIBUTOR REPRESENTATIVE. THE PATIENT, A (AGE UNSPECIFIED) MALE EXPERIENCED NON-SPECIFIED INJURY TO THE CORNEAL ENDOTHELIUM AFTER THE SYRINGE HANDLE DISENGAGED FROM THE SYRINGE AND THE CANNULA HIT THE CORNEAL ENDOTHELIUM DURING A SURGICAL PROCEDURE USING BD 1% OVD (1% SODIUM HYALURONATE) VISCOELASTIC SURGICAL AID. IT WAS INITIALLY REPORTED TO THE MANUFACTURER ON (B)(6) 2010 THAT A PATIENT WAS INJURED DURING SURGERY INVOLVING USE OF THE PRODUCT. FURTHER INFORMATION WAS RECEIVED ON (B)(6) 2010; DURING THE SURGICAL PROCEDURE AFTER PHACOEMULSIFICATION, THE HANDLE OF THE VISCOELASTIC SYRINGE DISENGAGED AND THE SYRINGE BECAME UNSTABLE WHICH CAUSED THE CANNULA TO INADVERTENTLY RUB THE CORNEAL EPITHELIUM. A CATARACT PROCEDURE WAS PERFORMED ON THE PATIENT AND THE FLANGED PIECE THAT FITS ON THE SYRINGE FLEW OUT OF THE SURGEON'S HAND AND HIT THE PATIENT'S EPITHELIUM. AS A RESULT, SECONDARY SURGERY (DSEAK, DESCEMETS STRIPPING AUTOMATED ENDOTHELIAL KERATOPLASTY) WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD 1% OVD 1% SODIUM HYALURONATE LZP BIO-TECHNOLOGY GENERAL (ISRAEL) LTD. RD0007A SUSPECTED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention