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U.S. Department of Health and Human Services

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

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ALCON RESEARCH, LLC - HOUSTON CENTURION SURGICAL PROCEDURE PAK GENERAL SURGERY TRAY (KIT) Back to Search Results
Catalog Number ASKU
Device Problem Break (1069)
Patient Problems Fluid Discharge (2686); Device Embedded In Tissue or Plaque (3165)
Event Date 11/05/2019
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 company representative reported a surgeon experienced a broken phaco needle during a procedure. Upon completion of the procedure, it appeared as "nothing was wrong". The patient returned for the one day postoperative visit and was experiencing a wound leakage. The surgeon took the patient back to the operating room to place a suture in the wound and during this procedure, he found a small, clear piece of material in the wound. During the sixth day postoperative visit after the second procedure, the surgeon indicated the patient is doing well, the eye was quiet and the wound was secure.

 
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Brand NameCENTURION 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 Key9387156
MDR Text Key168434073
Report Number1644019-2019-00184
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 COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/13/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/27/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberASKU
Device LOT NumberASKU
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 Received01/30/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 11/27/2019 Patient Sequence Number: 1
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