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

Model Number TABLETOP

Device Problems Overheating of Device (1437); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2020

Event Type  malfunction  

Manufacturer Narrative

A product sample was received and it is awaiting 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 customer reported that during an ocular procedure, the surgeon indicated he felt that the laser was hotter or treatment was too effective at times.The procedure was completed with the same laser probe and system without harm to the patient.It was also reported that the main foot pedal was sticky.Additional information was requested; however, the reporter indicated that there is no further information available.

Manufacturer Narrative

Additional information has been provided in d.10, h.3, h.6, and h.10.The company service representative examined the system and was unable to duplicate the problem reported.The footswitch was replaced as a prevention.The system was then tested and met all product specifications.The footswitch was received and a visual assessment did not find any non-conformities.Further evaluation found no problem with the footswitch.Based on assessment, the product met specifications at the time of release.The root cause of the reported event cannot be determined conclusively.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: 9689770
• MDR Text Key: 182780708
• Report Number: 2028159-2020-00078
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 01/31/2020
• Initial Date Manufacturer Received: 01/15/2020
• Initial Date FDA Received: 02/10/2020
• Supplement Dates Manufacturer Received: 04/22/2020
• Supplement Dates FDA Received: 05/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LASER PROBE