Model Number ASKU |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
Injury
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Manufacturer Narrative
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Evaluation summary: 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 following the implant of an intraocular lens (iol), the lens was exchanged for an unknown reason.Additional information was requested.
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Manufacturer Narrative
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The product was not returned for analysis.The complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The product investigation could not identify a root cause for the reported complaint.Not enough information was provided from the account for further investigation.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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