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

Model Number TABLETOP

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Phototoxicity (2165)

Event Date 11/30/2018

Event Type  Injury  

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 customer reported that autofluorescence alterations were present postoperatively.Phototoxicity of the right eye is suspected.Additional information has been requested.

Manufacturer Narrative

The company representative determined that the ¿upper-light-source was used with a 23 gauge wide field probe in the first port during three surgeries for that same day (per event logs).The light was measured and fell within specifications.The company service representative examined the system in order to measure the illumination output, as well as the laser function per customer¿s request.The company service representative tested the system¿s tabletop illuminator and found ports 1 and 2 outputs to be 10 and 12 lumens, respectively.This meets the product specifications to be between 10-22 lumens.The system was then tested and met all product specifications.Based on assessment, the product met specifications at the time of release.The system was found to meet relevant functional specifications; therefore, 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: 8221637
• MDR Text Key: 132204219
• Report Number: 2028159-2019-00041
• 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: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TABLETOP
• Device Catalogue Number: 8065751150
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/14/2018
• Initial Date FDA Received: 01/07/2019
• Supplement Dates Manufacturer Received: 03/14/2019
• Supplement Dates FDA Received: 04/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PERFLUOROCARBON LIQUID; SULFUR HEXAFLUORIDE; PERFLUOROCARBON LIQUID; SULFUR HEXAFLUORIDE
• Patient Outcome(s): Other