BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFT CELL PVA FOAM SURGICAL SPEAR

    MDR report key: 921733 · Received September 25, 2007

    Report

    Report Number
    2083373-2007-00005
    Event Type
    Other
    Date Received
    September 25, 2007
    Report Date
    September 25, 2007
    Manufacturer
    OASIS MEDICAL, INC.
    Product Code
    HOZ
    PMA / PMN Number
    K950241
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON NOTIFICATION A REVIEW OF PRODUCTION RECORDS WAS INITIATED. THERE WERE NO ANOMALIES OR REMARKABLE EVENTS THAT OCCURRED THAT WOULD ADVERSELY IMPACT THE PRODUCT. OF THE SPEARS DISTRIBUTED TO DATE, THERE HAVE BEEN NO OTHER ADVERSE EVENTS OR COMPLAINTS REPORTED REGARDING PRODUCT #0525, LOT # 163282. AT THIS TIME, THERE IS NO EVIDENCE TO SUGGEST THAT THE SOFT CELL PVA FOAM SURGICAL SPEARS PRODUCT #0525, LOT #163282 ARE DIRECTLY OR INDIRECTLY RESPONSIBLE FOR THE REPORTED DLK OBSERVATION.

    Description of Event or Problem · 1

    SURGERY DATE 2007. TRACE DLK NOTED DAY 1 RIGHT EYE. PRED FORTE INCREASED TO EVERY 2 HRS. DLK RESOLVED AND ON LAST FOLLOW UP 2 DAYS LATER, VISION WAS 20/20 OU WITHOUT CORRECTION.

    Additional Manufacturer Narrative · 2

    UPON NOTIFICATION A REVIEW OF PRODUCTION RECORDS WAS INITIATED. THERE WERE NO ANOMALIES OR REMARKABLE EVENTS THAT OCCURRED THAT WOULD ADVERSELY IMPACT THE PRODUCT. OF THE SPEARS DISTRIBUTED TO DATE, THERE HAVE BEEN NO OTHER ADVERSE EVENTS OR COMPLAINTS REPORTED REGARDING PRODUCT #0525, LOT # 163282. AT THIS TIME THERE IS NO EVIDENCE TO SUGGEST THAT THE SOFT CELL PVA FOAM SURGICAL SPEARS PRODUCT #0525, LOT #163282 ARE DIRECTLY OR INDIRECTLY RESPONSIBLE FOR THE REPORTED DLK OBSERVATION.

    Description of Event or Problem · 2

    SURGERY DATE 2007. TRACE DLK NOTED OD ON POD 1. PRED FORTE INCREASED TO EVERY 2 HRS. LAST FOLLOW UP ONE WEEK LATER. A FEW CELLS REMAINED. PT REFRACTED TO 20/20 WITH MILD MYOPIC CORRECTION.

    Additional Manufacturer Narrative · 3

    UPON NOTIFICATION A REVIEW OF PRODUCTION RECORDS WAS INITIATED. THERE WERE NO ANOMALIES OR REMARKABLE EVENTS THAT OCCURRED THAT WOULD ADVERSELY IMPACT THE PRODUCT. OF THE SPEARS DISTRIBUTED TO DATE, THERE HAVE BEEN NO OTHER ADVERSE EVENTS OR COMPLAINTS REPORTED REGARDING PRODUCT #0525, LOT # 163282. AT THIS TIME THERE IS NO EVIDENCE TO SUGGEST THAT THE SOFT CELL PVA FOAM SURGICAL SPEARS PRODUCT #0525, LOT #163282 ARE DIRECTLY OR INDIRECTLY RESPONSIBLE FOR THE REPORTED DLK OBSERVATION.

    Description of Event or Problem · 3

    SURGERY 2007. TRACE DLK OS ON POD #1... PRED FORTE EVERY 2 HRS. DID NOT PROGRESS BUT STILL PRESENT ON DAY 4 (4 DAYS LATER). VISION 20/25 WITHOUT CORRECTION.

    Additional Manufacturer Narrative · 4

    UPON NOTIFICATION A REVIEW OF PRODUCTION RECORDS WAS INITIATED. THERE WERE NO ANOMALIES OR REMARKABLE EVENTS THAT OCCURRED THAT WOULD ADVERSELY IMPACT THE PRODUCT. OF THE SPEARS DISTRIBUTED TO DATE, THERE HAVE BEEN NO OTHER ADVERSE EVENTS OR COMPLAINTS REPORTED REGARDING PRODUCT #0525, LOT # 163282. AT THIS TIME THERE IS NO EVIDENCE TO SUGGEST THAT THE SOFT CELL PVA FOAM SURGICAL SPEARS PRODUCT #0525, LOT #163282 ARE DIRECTLY OR INDIRECTLY RESPONSIBLE FOR THE REPORTED DLK OBSERVATION.

    Description of Event or Problem · 4

    SURGERY 2007. TRACE DLK OD WITH SMALL FIBER ASSOICATED WITH THE DLK. PRED FORTE EVERY 2 HRS. DAY 3 VISION 20/20... DLK RESOLVED (3 DAYS LATER).

    Additional Manufacturer Narrative · 5

    UPON NOTIFICATION A REVIEW OF PRODUCTION RECORDS WAS INITIATED. THERE WERE NO ANOMALIES OR REMARKABLE EVENTS THAT OCCURRED THAT WOULD ADVERSELY IMPACT THE PRODUCT. OF THE SPEARS DISTRIBUTED TO DATE, THERE HAVE BEEN NO OTHER ADVERSE EVENTS OR COMPLAINTS REPORTED REGARDING PRODUCT #0525, LOT # 163282. AT THIS TIME THERE IS NO EVIDENCE TO SUGGEST THAT THE SOFT CELL PVA FOAM SURGICAL SPEARS PRODUCT #0525, LOT #163282 ARE DIRECTLY OR INDIRECTLY RESPONSIBLE FOR THE REPORTED DLK OBSERVATION.

    Description of Event or Problem · 5

    SURGERY 2007 AT DAY 1, STAGE 1 DLK NOTED IN BOTH EYES. PRED FORTE EVERY HOUR WHILE AWAKE PRESCRIBED. ON DAY 3, DLK PROGRESSED TO STAGE 2 IN FRONT OF PUPIL BUT WAS NOT DENSE. SAW PT AGAIN ON DAY 4 (4 DAYS LATER), DLK WAS NO WORSE, VISION 20/20 UNCORRECTED. CELLS VERY SPARSE. WILL FOLLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFT CELL PVA FOAM SURGICAL SPEAR FOAM SPEAR HOZ OASIS MEDICAL, INC. 0525 163282

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other
    2 38 YR
    3 38 YR
    4 32 YR
    5 42 YR