Catalog Number 8065751763 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Corneal Decompensation (1790); Inflammation (1932)
|
Event Date 12/16/2021 |
Event Type
Injury
|
Event Description
|
A physician reported that a patient had mild postoperative inflammation and postoperative corneal deformity in the left eye.The procedure details was not reported.
|
|
Manufacturer Narrative
|
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).
|
|
Manufacturer Narrative
|
The company representative (did not) confirm nor replicate the reported event.The system was tested and found to meet product specifications.A non-conformance-based review of the batch/lot/serial number was performed and did not reveal any potential contributing factors to the reported complaint.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.A review for complaints reported against this lot/batch/serial number was performed.A potentially relevant complaint was found and reviewed as part of this investigation.The system was found to meet specifications.Therefore, the root cause of the reported event is inconclusive.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
|
|
Search Alerts/Recalls
|