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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 ASKU
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
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. (b)(4).

 
Event Description

A customer reported that during post op visit a colorless twisted fiber was found in the corneal incision site. The fiber was removed and there was no reported patient harm.

 
Manufacturer Narrative

The lot complaint history was reviewed; this is the fourth complaint for the finish goods lot and fourth for this issue for this lot. The device history record shows the product was released per specifications. It has been noted all four complaints have originated from the same customer within a two day period. The root cause of the customer's complaint could not be established as a sample has not been received. Without a sample, it is not possible to isolate the root cause. As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined. Action will not be taken for this occurrence as no sample was returned and root cause evaluation could not be performed. Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate. Manufacturing management and quality engineering materials will be made aware of this complaint through the monthly complaint review meeting. It is recommended that the customer place the surgical instruments on a mayo tray and if applicable avoid placing them directly on a mayo stand cover or the back table cover. Additionally, the instruments should be wiped before passing back to the surgeon. This will assist in preventing lint contamination on instruments and help to reduce the risk of lint getting into the patient eye. (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
bryan blake
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152230
MDR Report Key7996970
MDR Text Key124789411
Report Number1644019-2018-00249
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 RISK MANAGER
Type of Report Initial,Followup
Report Date 01/09/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/23/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/28/2020
Device Catalogue NumberASKU
Device LOT Number2164522H
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 Received12/21/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/18/2018
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: 10/23/2018 Patient Sequence Number: 1
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