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U.S. Department of Health and Human Services

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

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ALCON RESEARCH, LTD. - HOUSTON INFINITI SURGICAL PROCEDURE PAK GENERAL SURGERY TRAY (KIT) Back to Search Results
Catalog Number 8065741081
Device Problem Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
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 the sleeves are twisting when entering the eye in an unspecified quantity of eye surgeries. To resolve the issue the surgeon extended the wound from 2. 75 millimeter to a 3. 0 millimeter and a suture was not required. There was no patient harm. A product sample has been requested for this report. There is no additional information available at this time.

 
Manufacturer Narrative

There have been no additional complaints reported against the finish goods lot and the device history record shows that the product was released per specifications. The customer did not retain a sample for this complaint report; visual inspection or functional testing could not 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. (b)(4).

 
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Brand NameINFINITI 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
eddie darton, md, jd
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8175686660
MDR Report Key5644788
MDR Text Key45005915
Report Number1644019-2016-00766
Device Sequence Number1
Product Code LRO
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberK880961
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 06/21/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/10/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2018
Device Catalogue Number8065741081
Device LOT Number1857027H
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 Received06/17/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/05/2016
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: 05/10/2016 Patient Sequence Number: 1
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