• 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, LTD. - HOUSTON CENTURION 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, LTD. - HOUSTON CENTURION SURGICAL PROCEDURE PAK GENERAL SURGERY TRAY (KIT) Back to Search Results
Catalog Number 8065752201
Device Problem Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/02/2017
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 surgeon observed two phaco tips with burrs on them during two surgery cases. There was no harm to the patients and the product was not retained. No additional information is expected.

 
Manufacturer Narrative

No phaco tips were returned for evaluation for the report of the two tips having burr; therefore, the condition of the product could not be verified. A review of the device history records traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria. A complaint history examination indicates there were no additional complaints associated with the lot for the reported issue. Because the phaco tip samples were not returned by the customer and the device history record review of the lot number provided indicated the product was processed and released according to the product¿s acceptable criteria, the root cause for customer complaint issue cannot be determined. No specific action with regard to this complaint was taken by the manufacturing facility because no complaint samples were received to determine a root cause. Phaco tips are 100% visually inspected by trained operators during the manufacturing process. No additional action is required at this time. The manufacturer internal reference number is: (b)(4).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCENTURION SURGICAL PROCEDURE PAK
Type of DeviceGENERAL SURGERY TRAY (KIT)
Manufacturer (Section D)
ALCON RESEARCH, LTD. - HOUSTON
9965 buffalo speedway
houston TX 77054
Manufacturer (Section G)
ALCON RESEARCH, LTD. - HOUSTON
9965 buffalo speedway
houston TX 77054
Manufacturer Contact
nadia bailey
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152230
MDR Report Key6823558
MDR Text Key83954737
Report Number1644019-2017-00709
Device Sequence Number1
Product Code LRO
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK880961
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 11/13/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/28/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/31/2018
Device Catalogue Number8065752201
Device LOT Number1981022H
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 Received10/17/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/05/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/28/2017 Patient Sequence Number: 1
-
-