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U.S. Department of Health and Human Services

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

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ALCON RESEARCH, LTD. - HOUSTON CUSTOM-PAK SURGICAL PROCEDURE PACK GENERAL SURGERY TRAY (KIT) Back to Search Results
Catalog Number 16540-01
Device Problem Insufficient Information (3190)
Patient Problem No Code Available (3191)
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

Customer reported that a fiber was noted inside the patient's anterior chamber. The patient had to come back to the operating room to have the fiber removed. Additional information has been requested for this event.

 
Manufacturer Narrative

The product lot specific to this event is not known; therefore, a lot history review and a device history record reviews are not possible. No sample was returned for visual inspection or analysis. The source of the fiber could not be determined. (b)(4).

 
Manufacturer Narrative

(b)(4).

 
Event Description

Additional information was received; it was informed that the fiber was sent to a lab for evaluation. The reporter informed that "it is unknown if the fiber is synthetic or not. ".

 
Manufacturer Narrative

Based on the customer report, the investigation could not determine the exact root cause of when and where the white fiber entered the eye. The customer stated the patient returned to the operating room to have the fiber removed, the possibility of the foreign fiber entering the eye during this time could be ruled out. Additionally, the suspect sample was not returned for this investigation. An internal investigation has been opened to address reports of a similar nature. The manufacturer internal reference number is: (b)(4).

 
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Brand NameCUSTOM-PAK SURGICAL PROCEDURE PACK
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
rita lopez
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8175514846
MDR Report Key6001128
MDR Text Key56506116
Report Number1644019-2016-01285
Device Sequence Number1
Product Code LRO
Combination Product (Y/N)N
Reporter Country CodeNZ
PMA/PMN NumberK880961
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation HEALTH PROFESSIONAL
Remedial Action Other
Type of Report Initial,Followup,Followup,Followup
Report Date 02/09/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/05/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number16540-01
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 Received02/08/2017
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: 10/05/2016 Patient Sequence Number: 1
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