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U.S. Department of Health and Human Services

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

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ALCON RESEARCH, LTD. - HOUSTON LAUREATE SURGICAL PROCEDURE PAK GENERAL SURGERY TRAY (KIT) Back to Search Results
Catalog Number 8065750541
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
Event Date 09/04/2018
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 surgeon reported a patient developed toxic anterior segment syndrome postoperatively. The surgeon indicated the patient required an unspecified intervention and the symptoms are continuing. The patient condition improved with slight haze on the lens surface. Additional information was requested; however, none has been received to date. This is one of three reports for this surgeon.

 
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Brand NameLAUREATE 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
bryan blake
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152230
MDR Report Key7915579
MDR Text Key121924567
Report Number1644019-2018-00231
Device Sequence Number1
Product Code LRO
Combination Product (Y/N)N
Reporter Country CodeIN
PMA/PMN NumberK880961
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/19/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/27/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/29/2020
Device Catalogue Number8065750541
Device LOT Number2139730H
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 Received12/03/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/15/2018
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: 09/27/2018 Patient Sequence Number: 1
Treatment
LAUREATE WORLD PHACO SYSTEM
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