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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 Insufficient Information (3190)
Patient Problem No Information (3190)
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 patient returned last month to have fibers removed from the eye.Additional information was requested; however, none has been received to date.
 
Manufacturer Narrative
Additional information provided.The finished good lot specific to this event is not known; therefore, lot history and device history record review was not possible.The customer reported that they found white fibers in the patient¿s eye.A sample has not been returned for this complaint.When this type of issue occurs, a sample will need to be returned so that a proper investigation can be conducted.If a sample is returned at a later date, the investigation will be reopened and the sample evaluated.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.Quality assurance will continue to monitor and take action for any future occurrences as is deemed necessary.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.The manufacturer internal reference number is: (b)(4).
 
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Brand Name
CUSTOM-PAK SURGICAL PROCEDURE PACK
Type of Device
GENERAL SURGERY TRAY (KIT)
Manufacturer (Section D)
ALCON RESEARCH, LTD. - HOUSTON
9965 buffalo speedway
houston TX 77054
MDR Report Key7952658
MDR Text Key123496943
Report Number1644019-2018-00239
Device Sequence Number1
Product Code LRO
Combination Product (y/n)N
PMA/PMN Number
K880961
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 01/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberASKU
Device Lot NumberASKU
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/20/2018
Initial Date FDA Received10/10/2018
Supplement Dates Manufacturer Received12/19/2018
Supplement Dates FDA Received01/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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