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

Catalog Number 8065753041

Device Problem Optical Problem (3001)

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

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 during a retinal detachment surgery, the ophthalmic system presented with low illumination from multiple ports.The surgery was completed by using illumination from back up ports.There was no impact to the patient.

Manufacturer Narrative

The system was examined.And the reported event was not replicated.However, the contaminated illumination port was cleaned 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 contaminated illumination port.However, there was no issue with the system itself.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: 11235419
• MDR Text Key: 229887444
• Report Number: 2028159-2021-00089
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/30/2021

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 Catalogue Number: 8065753041
• Device Lot Number: 125UYN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/10/2021
• Initial Date FDA Received: 01/27/2021
• Supplement Dates Manufacturer Received: 04/09/2021
• Supplement Dates FDA Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1