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 No Patient Involvement (2645)

Event Date 02/11/2020

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 a lamp issue during testing of the equipment.There was no patient involvement.Additional information has been requested.

Manufacturer Narrative

Additional information is provided in d.10., h.3., h.6.And h.10.The company service representative examined the system, but was unable to replicate the reported lamp issue.However, the company service representative noted that the lamp had over 400 hours of use.The xenon lamp was replaced as a preventive measure.The system was then tested 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.It should be noted that on the system¿s touchscreen, an illuminated ring surrounding the on/off button(s) of the illuminator global controls indicates to the user the number of lamp hours.Page 2.46 of the operator¿s manual describes that the indicator rings have three indication colors: green (0-199 hours), yellow (200-399 hours), and orange (400 hours or more).In addition, the system displays system message (sm) 5104 [the lamp has exceeded its rated life: lamp needs to be replaced.Please contact field service] when the lamp has reached 400 hours.The system message can only be cleared by the user pressing a button on the screen.The system message is an advisory for the user to replace the lamp; however, the lamp can still be used after this system message is acknowledged.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: 9968691
• MDR Text Key: 188322955
• Report Number: 2028159-2020-00348
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2020
• 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: 06/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1