Catalog Number 8065750352 |
Device Problems
Collapse (1099); Device Slipped (1584)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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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 the sleeve slid off the irrigation and aspiration tip during four eye procedures when sweeping the anterior capsule causing the anterior chamber to collapse.There was no patient harm associated with this event.A product sample was requested for evaluation.
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Manufacturer Narrative
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As the customer did not retain the finished goods lot number; a device history record review and lot history could not be conducted.The customer did not retain a sample for this complaint report; visual inspection or functional testing could not be conducted.It is important to remind the customer to return all products associated with the event for a full evaluation.The root cause of the customer's complaint could not be established as a sample has not been received.Without a sample, it is not possible to isolate the root cause.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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