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

Model Number TABLETOP

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 the system's illumination light bulb was dim.

Manufacturer Narrative

Corrected information provided in h10.Additional information provided in d9, not in d10 as previously reported.The manufacturer internal reference number is:(b)(4).

Manufacturer Narrative

The previous report submitted for this event contained an error in h.1.- ¿summary report¿ was inadvertently selected.After a recent system update, a system error caused the inadvertent additional selection of ¿summary report¿ in h.1.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The company service representative examined the system and replicated the reported event.The non-conforming xenon lamp was replaced to resolve the issue.Unrelated to the reported event, the card reader printed circuit board (pcb) and vitrectomy valve cable were replaced.The system was then tested and met all product specifications.The system was manufactured on (b)(6) 2013.Based on qa assessment, the product met specifications at the time of release.The root cause of the reported event can be attributed to the non-conforming xenon lamp.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: 10993491
• MDR Text Key: 221542619
• Report Number: 2028159-2020-01099
• 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,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/16/2021

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 Model Number: TABLETOP
• Device Catalogue Number: 8065751150
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/20/2020
• Initial Date FDA Received: 12/11/2020
• Supplement Dates Manufacturer Received: 03/04/2021; 03/04/2021; 03/03/2021
• Supplement Dates FDA Received: 03/04/2021; 03/04/2021; 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1