MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CONSTELLATION VISION SYSTEM; UNIT, PHACOFRAGMENTATION

Model Number TABLETOP

Device Problems Failure to Shut Off (2939); Operating System Becomes Nonfunctional (2996)

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

Event Type  malfunction  

Manufacturer Narrative

No sample 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 health professional reported that an ophthalmic operating system locked up and would not shut down with no report of any system message being displayed.Procedure details information is unknown.There was no report of any patient harm.Additional information has been requested.Additional information received further clarified that after set up for the procedure and after successful prime and tune, the system would just freeze up and they were unable to use any of the functions or turn the system off.The system had to be unplugged and removed from the or.A new system was brought in to complete the set up for the scheduled procedure.The complained system was reported to have been addressed by technical services personnel who found a software issue that was repaired by replacing hardware.The system has been used with no further issues.No further patient or procedure details are available to provide.

Manufacturer Narrative

Additional information is provided in sections d.9, h.3, h.6 and h.10.The system was examined and the reported event was replicated.The host module was subsequently replaced to resolve the issue.The system was tested and found to meet product specifications.The manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The root cause of the reported event can be attributed to a nonconforming host module.Data will continue to be monitored for evidence of adverse trending with further action taken, as appropriate.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The host was received for evaluation.A visual assessment of the returned sample revealed no obvious non-conformity.The returned sample was installed into a system and tested.The screen froze after sometime.The reported event was replicated.The root cause was attributed to the printed circuit board (pcb).The root cause of the reported event can be attributed to the hd video overlay of the host module.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 11628577
• MDR Text Key: 244242230
• Report Number: 2028159-2021-00354
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00380657511501
• UDI-Public: 00380657511501
• Combination Product (y/n): N
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TABLETOP
• Device Catalogue Number: 8065751150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2021
• Date Manufacturer Received: 11/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1