Model Number BL3318A |
Device Problem
Break (1069)
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Patient Problems
Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The manufacturing and lot history records were reviewed and found to be acceptable.Additional information has been requested.The investigation is ongoing.(report 2 of 2; see also 0001920664-2021-00052).
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Event Description
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A user facility in (b)(6) reported that, during surgery, the phaco tip broke.The broken tip entered the patient's eye and was removed from the eye.The tip was replaced with another one and the surgery was completed without any patient injury.The surgery was prolonged approximately 5 minutes and no additional anesthesia was required.The patient has recovered.
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Manufacturer Narrative
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The device has not been returned for evaluation.A supplemental report will be submitted if any additional information is received.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.The investigation is complete.(report 2 of 2; see also 0001920664-2021-00052).
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Manufacturer Narrative
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The device was returned without the original packaging and the part number and lot number cannot be verified or determined.Visual inspection found the needle was fractured and nearly completely severed near the tip with marring, gouges, scratches, and faded color on sections of the shaft.The broken area of the cannula had jagged edges and there were dings and bends on the edges of the tips.Further evaluation determined the fracture occurred approximately 0.150" away from the tip of the needle with deep gouges near the fracture point and severe damage at the tip of the needle.The needle also showed significant damage at the hub area, indicative of the installation wrench used in the field.The wall thickness of the needle did not show significant shift and was consistent with the normal phaco needle manufacturing process.Each needle is 100% inspected for obvious visual defects as well as any obvious manufacturing defects prior to shipment.Mechanical damage was evident but the evaluation of the returned product did not reveal the specific cause.The investigation is complete.(report 2 of 2; see also 0001920664-2021-00052).
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Search Alerts/Recalls
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