Catalog Number 8065000123 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Keratitis (1944)
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Event Date 01/11/2022 |
Event Type
Injury
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Event Description
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Customer reported diffuse lamellar keratitis in the right eye of a patient, after lasik surgery.There are multiple related reports for this reported event.This report addresses patient initials ob, right eye, and additional manufacturer reports will be filed for the other patients.
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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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Manufacturer Narrative
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A review of the device history record (dhr) traceable to the reported serial number indicates that the product was processed and released according to the product¿s acceptance criteria.A review of the technical service onsite history showed no abnormalities that could have contributed to this event: laser was successfully verified prior to and after the day of the treatment.Review of the logfiles for the day of treatment shows no relevant errors or any relevant warnings.During start-up of the system the vacuum, the energy and the ablation tests were performed without any issue.The energy was stable during the whole day.The logfile shows four successfully performed treatments.The reported treatment could be identified in the logfile.The logfile shows that the beam control check for the treatment was conducted about one thirty seven minutes before starting procedure instead of immediately before procedure.The logfile shows one treatment interruption due to a release of the laser pedal.The treatment was finished successfully without any issue.No relevant deviation between planed and performed energy is detectable for the reported treatment.The user operated surgery within the recommended energy settings.The thickness of the flap was thinner than the recommended flap thickness.No technical root cause could be identified.No sample was returned to the manufacturer for evaluation.Root cause for the customer¿s reported event could not be determined conclusively, however occurrences of diffuse lamellar keratitis are a known complication of lasik and other refractive surgeries; it is not likely that a product malfunction could have contributed to the reported event.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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