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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
Device Problem Insufficient Information (3190)
Patient Problem No Code Available (3191)
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. (b)(4).

 
Event Description

A customer reported that a fiber was seen in a patient's eye post-operative from an eye surgery. Additional information and product sample have been requested for this report.

 
Manufacturer Narrative

Additional information in device evaluated by mfr?, evaluation codes and additional mfr narrative. A device history record review for the reported lot indicates that the order was built to specification. The drawing for this pack was reviewed and the drapes, sponge gauze, mayo stand cover, cotton tip applicators, eye spears, eye pad, and instrument wipe were identified components in this pack that could contribute to lint and fibers. It was also noted that the sponge gauze is placed in the emesis basin. A sample has not been returned for this complaint; therefore, visual inspection could not be performed. Additionally, the customer did not provide any details describing the type of fiber found. This file will be processed for closure and opened at a later date if a sample is returned. The root cause of the complaint is not known; a sample was not returned for investigation. An internal investigation has been opened to address reports of a similar nature. (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 Key6134865
MDR Text Key61439901
Report Number1644019-2016-01467
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,USER FACILITY
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 02/15/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/30/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/29/2018
Device Catalogue Number16540
Device LOT Number1791587H
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/02/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/09/2015
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: 11/30/2016 Patient Sequence Number: 1
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