MAUDE Adverse Event Report: ALCON RESEARCH, LLC CONSTELLATION VISON SYSTEM; UNIT, PHACOFRAGMENTATION

Device Problems Crack (1135); Energy Output Problem (1431)

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

Event Date 09/25/2020

Event Type  malfunction  

Event Description

The mirror in the constellation machine was cracked affecting the light in the illumination laser.Fda safety report id# (b)(4).

• Brand Name: CONSTELLATION VISON SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC
• MDR Report Key: 10619340
• MDR Text Key: 209847705
• Report Number: MW5097018
• Device Sequence Number: 1
• Product Code: HQC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR