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

Model Number TABLETOP

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 01/09/2018

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.The manufacturer internal reference number is: (b)(4).

Event Description

A medical technologist reported that the surgeon's vision was "dazzled" by the laser looking through the microscope.It was noted that the staff has a retractable doctor filter.The nurse responded "yes" to the system query of "doctor filter inserted" although the doctor filter was not in.The case was completed as planned after inserting the laser filter.

Manufacturer Narrative

Based on information received following submission of the initial report, this event does not meet criteria for reporting as a serious injury incident.(b)(4).

Event Description

New information has been received indicating the surgeon was able to complete the planned surgery without problem.The surgical staff has inserted the filter and all following surgeries could be performed.There was no harm to the surgeon.

• Brand Name: CONSTELLATION VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7227358
• MDR Text Key: 98544859
• Report Number: 2028159-2018-00213
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date: 02/15/2018

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
• Other Device ID Number: 4.00.168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2018
• Initial Date FDA Received: 01/30/2018
• Supplement Dates Manufacturer Received: 01/17/2018
• Supplement Dates FDA Received: 02/15/2018
• Date Device Manufactured: 04/12/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other