Model Number 550 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 12/27/2022 |
Event Type
Injury
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Event Description
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A healthcare professional reported a patient with detached descemet membrane at the site of incision made during surgery.
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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).The manufacturer internal reference number is: (b)(4).
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Event Description
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Additional information received.Stated, surgery completed without using laser made incision.And created incision with keratome.There was no patient impact.
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Manufacturer Narrative
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The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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Additional information provided in h.3., h.6., and h.10.A manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.Service history was reviewed for the system.There was no service record (relevant to the reported event) found.However, the system was last serviced prior to the reported event per service record (sr).The system found to meet all cosmetic and performance standards.The customer reported event cannot be confirmed.Thus, based on the information obtained, the root cause of the reported event is inconclusive.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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