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

Model Number TABLETOP

Device Problem Firing Problem (4011)

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.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported that the laser instrumentation worked properly, however, the laser was only "firing a little bit." additional information has been requested.

Manufacturer Narrative

Additional information provided in d.10., d.11., h.3., h.6., and h.10.The company service representative examined the system and replicated the reported event.The company service representative found the issue to be that the laser indirect ophthalmoscope (lio) was not working properly.Unrelated to the reported event, the xenon lamp was replaced.The system was functioning as intended.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 laser indirect ophthalmoscope (lio) headpiece 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.The root cause of the reported event can be attributed to a nonconforming laser indirect ophthalmoscope (lio) headpiece.The system itself was found to meet specifications.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: 9765593
• MDR Text Key: 184456651
• Report Number: 2028159-2020-00163
• 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,other
• Type of Report: Initial,Followup
• Report Date: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• 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?: Yes
• Date Manufacturer Received: 06/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LIO PUREPOINT