Catalog Number ASKU |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Endophthalmitis (1835)
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Event Date 06/15/2020 |
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.The manufacturer internal reference number is: (b)(4).
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Event Description
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A customer reported to the company representative that a patient experienced endophthalmitis following a routine cataract extraction with intraocular lend implant procedure.Additional information has been requested.
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Manufacturer Narrative
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Additional information has been provided in h.6.And h.10.No lot code or sample was provided; therefore lot specific investigation cannot be performed.No further evaluation or root cause analysis can be conducted at this time.No root cause could be determined as no sample or lot code was provided for analysis.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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