Catalog Number 8065751763 |
Device Problem
Decrease in Suction (1146)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/13/2022 |
Event Type
malfunction
|
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).
|
|
Event Description
|
A physician reported that during a cataract surgery an ophthalmic console exhibited poor aspiration in irrigation aspiration mode and phacoemulsification phase.The surgery was completed without patient impact.
|
|
Manufacturer Narrative
|
The company representative confirmed and replicated the reported event.The fluidics module was replaced to address the issue.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 complaint was opened for a cassette that caused aspiration issues and is in progress at the time of this investigation.The root cause of the reported event is attributed to the nonconforming fluidics module.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
|