• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ALCON RESEARCH, LLC - HOUSTON CONSTELLATION SURGICAL PROCEDURE PAK; GENERAL SURGERY TRAY (KIT) Back to Search Results
Catalog Number 8065752448
Device Problem Fluid/Blood Leak (1250)
Patient Problem Intraocular Pressure Decreased (4468)
Event Date 04/18/2022
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 physician reported leakage from the valved trocar during cataract/vitrectomy surgery and intra ocular pressure monitoring was compromised.The intra ocular pressure dropped causing softening of the globe.The surgery was completed on the same day.There was no patient harm.
 
Manufacturer Narrative
Three opened trocar assemblies in a (small parts tray).Smpt within a tray were received, for the report of there was a leak on the valved trocars and the intra ocular pressure decreased.The returned samples were visually inspected and were found to be non-conforming with damaged and torn septum's.Leak testing could not be performed, due to the damage of the samples.A review of the device history record traceable to the reported lot number, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The photo attached to the parent complaint was reviewed, by the manufacturing site.The exact root cause for this complaint is unknown.The damaged condition of the valves could have contributed to the reported event.How and when, the valve became damaged cannot be determined, from the evaluation performed.The exact root cause for this complaint is unknown.Therefore, specific action for this complaint cannot be taken.An acceptance quality inspection is performed to ensure product meets release acceptance criteria.This inspection includes evaluation for damaged valves.Complaints are reviewed and monitored at regular intervals to evaluate effectiveness of actions taken.No adverse trends have been observed, associated with the reported product and event.No further actions are required.The manufacturer internal reference number is: (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CONSTELLATION SURGICAL PROCEDURE PAK
Type of Device
GENERAL 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
8007579780
MDR Report Key14301682
MDR Text Key290930968
Report Number1644019-2022-00335
Device Sequence Number1
Product Code LRO
UDI-Device Identifier00380657524488
UDI-Public00380657524488
Combination Product (y/n)N
Reporter Country CodeRP
PMA/PMN Number
K880961
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial,Followup
Report Date 08/16/2022
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 Expiration Date05/31/2023
Device Catalogue Number8065752448
Device Lot Number2484828H
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/18/2022
Initial Date FDA Received05/06/2022
Supplement Dates Manufacturer Received07/25/2022
Supplement Dates FDA Received08/16/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-