Catalog Number 8065752917 |
Device Problem
Disassembly (1168)
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Patient Problem
Rupture (2208)
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Event Type
Injury
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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 a capsule rupture occurred during the phaco portion of an eye surgery.Upon follow up the customer informed tip dissatisfaction during the emulsification of the nucleus.Additional information and product sample have been requested for this event.
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Manufacturer Narrative
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Additional information in device evaluated by mfr?, evaluation codes.A product sample was not returned for evaluation.No lot number was identified with this complaint; therefore, a lot history review could not be conducted.Because a sample was not returned and no lot information was provided for a lot record review, the root cause for customer complaint issue cannot be determined.(b)(4).
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Search Alerts/Recalls
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