Catalog Number ASKU |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Corneal Edema (1791)
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Event Date 06/18/2020 |
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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An ophthalmic surgeon reported experiencing more corneal edema and a flap of the descemet layer postoperatively.The patients current outcome is unknown.Additional information has been requested.
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Manufacturer Narrative
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Additional information provided in h.3, h.6 and h.10.A sample was not received at the manufacturing site; therefore, the condition of the product could not be verified.No lot number was identified with this complaint; therefore, a device history record review could not be conducted.A sample was not received at the manufacturing site and no lot information was provided; therefore, the root cause for the customer complaint issue cannot be determined.The cause of the reported event cannot be determined with the information obtained; therefore, specific action with regards to this complaint cannot be taken.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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Additional information provided in b.5.The manufacturer internal reference number is: (b)(4).
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Event Description
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Additional information was received.The surgeon reported no further issue with corneal edema and "happy patients".
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Manufacturer Narrative
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Additional information provided in b.3.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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