Catalog Number 8065751795 |
Device Problem
Particulates (1451)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 12/08/2020 |
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 that some metal debris entered in the eye while performing irrigation/aspiration during a pars plana vitrectomy procedure.On the following day, the metal debris was observed inside the eye.No further information will be provided.
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Manufacturer Narrative
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A sample was not received at the manufacturing site for evaluation for the report of metal debris retained in eye; 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.The root cause could not be determined.All reusable handpieces and i/a tips are 100% visually inspected and functionally tested prior to being released from the manufacturing facility.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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