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

Model Number TABLETOP

Device Problem Intermittent Loss of Power (4016)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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.(b)(4).

Event Description

A healthcare professional reported the laser intermittently shuts off and the tabletop illumination has exceeded operational hours.Additional information has been requested.

Manufacturer Narrative

E-stop cable assembly was received for evaluation.A visual assessment of the sample showed that the e-stop button was broken into pieces and could not be functionally tested.It was visually confirmed to be nonconforming and no further testing was performed.However, how or when the laser e-stop button became nonconforming could not be determined conclusively.The root cause of the reported event can be attributed to a broken laser emo stop cable.The root cause of the reported event can be attributed to the lamp, which exceeded its rated life.However, no problem was found with the lamp as it functioned to its expected rated life.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The company service representative examined the system and replicated the reported event.The company service representative determined that the laser (emergency off) emo switch was broken.The company service representative replaced the laser emo stop cable and the xenon lamp to resolve the issues.The system was then tested and met all product specifications.The system 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 broken laser emo stop cable.The root cause of the reported event can be attributed to the xenon lamp, which exceeded its rated life.However, no problem was found with the xenon lamp as it functioned to its expected rated life.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: 8759126
• MDR Text Key: 150248836
• Report Number: 2028159-2019-01214
• 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,Followup
• Report Date: 10/08/2019

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: 08/23/2019
• Initial Date Manufacturer Received: 06/13/2019
• Initial Date FDA Received: 07/03/2019
• Supplement Dates Manufacturer Received: 07/15/2019; 10/07/2019
• Supplement Dates FDA Received: 07/30/2019; 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1