ALCON RESEARCH, LLC - ALCON PRECISION DEVICE INFINITI VISION SYSTEM, HANDPIECE TIP; UNIT, PHACOFRAGMENTATION
|
Back to Search Results |
|
Catalog Number 8065750852 |
Device Problems
Complete Blockage (1094); Suction Failure (4039)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/21/2021 |
Event Type
malfunction
|
Event Description
|
A customer reported an aspiration issue during a surgery.The product was replaced and the surgery was completed.There is no report of patient harm.Additional information was requested; however, none has been received to date.Additional information received from the company rep who indicated aspiration was absent and occlusion sound was continuously heard during the cataract procedure.
|
|
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
|
A sample was not received at the manufacturing site for evaluation for the report of the aspiration was absent; 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 is available, 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 adverse trends have been observed associated with the reported product and event.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).
|
|
Search Alerts/Recalls
|
|
|