Catalog Number 8065751908 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
Eye Injury (1845)
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Event Date 01/09/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation, including root cause analysis, is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.(b)(4).
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Event Description
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A customer reported leaky trocar valve during a left eye, combined, cataract and retina surgery, and hypotony occurred.The case was completed without harm to the patient.
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Manufacturer Narrative
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No sample has been returned for evaluation for the report of leaking trocar; therefore, the condition of the product could not be verified.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.No sample was returned and the device history record review of the lot number provided indicated product was processed and released according to the product¿s acceptance criteria, therefore the root cause for the defect experienced by the customer cannot be determined.(b)(4).
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Search Alerts/Recalls
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