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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON CONSTELLATION SURGICAL PROCEDURE PAK GENERAL SURGERY TRAY (KIT)

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ALCON RESEARCH, LLC - HOUSTON CONSTELLATION SURGICAL PROCEDURE PAK GENERAL SURGERY TRAY (KIT) Back to Search Results
Catalog Number 8065751767
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/16/2021
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 nurse reported two shiny pieces were observed from the vitrectomy probe during a vitrectomy procedure. The event occurred in the final stage of the procedure. The two pieces were removed during the same procedure. One piece is believed to be in the backflush which is not being returned. The backflush was replaced and the procedure was completed. The two pieces were removed during the same procedure. One piece is believed to be in the backflush which is not being returned. The surgeon believes the two pieces caused by the broken edge of the vitrectomy probe.

 
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Brand NameCONSTELLATION SURGICAL PROCEDURE PAK
Type of DeviceGENERAL SURGERY TRAY (KIT)
Manufacturer (Section D)
ALCON RESEARCH, LLC - HOUSTON
9965 buffalo speedway
houston TX 77054
Manufacturer (Section G)
ALCON RESEARCH, LLC - HOUSTON
9965 buffalo speedway
houston TX 77054
Manufacturer Contact
jonathan schlech
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8175514979
MDR Report Key11564905
MDR Text Key242206710
Report Number1644019-2021-00197
Device Sequence Number1
Product Code LRO
Combination Product (Y/N)N
Reporter Country CodeKS
PMA/PMN NumberK880961
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 03/24/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/24/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number8065751767
Device LOT Number2412423H
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/17/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/14/2020
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial

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