MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER HAND PIECE

Catalog Number ASKU

Device Problem Loss of Power (1475)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

No sample, no specific part number or lot number information has been received by manufacturing for evaluation.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 an ophthalmic operating handpiece suddenly lost power during surgery while in sculpt mode then continued to have no power with an alternate handpiece.The operating console was rebooted at which time the procedure was then completed while using the alternate handpiece.There was no report of any patient harm.Additional information has been requested.

Manufacturer Narrative

The phaco handpiece was not returned for evaluation.The serial number (s/n) was not provided.And could not be determined, based on the information provided.Therefore, manufacturing information could not be obtained.With no additional, related information provided.The customer's reported event could not be confirmed.The root cause cannot be determined conclusively.Similar incident data was collected for associated reported events.Quality assurance will continue to perform periodic monitoring for evidence of adverse trending.The manufacturer internal reference number is: (b)(4).

• Brand Name: HAND PIECE
• Type of Device: UNK
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 11655660
• MDR Text Key: 245109945
• Report Number: 2028159-2021-00364
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1