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U.S. Department of Health and Human Services

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

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ALCON RESEARCH, LTD. - HOUSTON CENTURION SURGICAL PROCEDURE PAK GENERAL SURGERY TRAY (KIT) Back to Search Results
Catalog Number 8065752918
Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105); Device Or Device Fragments Location Unknown (2590)
Patient Problem No Code Available (3191)
Event Date 08/16/2017
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. A product sample was received at the manufacturing site and it is awaiting evaluation. (b)(4).

 
Event Description

A customer reported that a piece of sleeve broke off and fell into the eye during an eye surgery with suspicion that it is still in the eye. No patient harm reported. A product sample and additional information has been requested for this report. No additional information has been received at this time.

 
Manufacturer Narrative

A device history review (dhr) indicates that the order was built to specifications. The returned sample was visually inspected and the issue was confirmed, a hole was found in the shaft of the infusion sleeve. The damage appears to have what resembles phaco tip piercing damage at the center section of the shaft. The root cause of the customer¿s complaint is most likely related to user handling during set-up. The marks on the sleeve have what resembles phaco tip damage; when the sleeve was installed over the phaco tip and the tip pierces the sleeve. (b)(4).

 
Manufacturer Narrative

Date received by mfg) for smdr 1 (mfg report num: 1644019-2017-00717) is 11/14/2017. The manufacturer internal reference number is: (b)(4).

 
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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 Key6854705
MDR Text Key85911293
Report Number1644019-2017-00717
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 OTHER
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup,Followup
Report Date 11/16/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/11/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2019
Device Catalogue Number8065752918
Device LOT Number2027261H
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/06/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/16/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/31/2017
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: 09/11/2017 Patient Sequence Number: 1
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