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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON - COUVREUR N.V./ALCON - BELGIUM DUOVISC VISCOELASTIC SYSTEM AID, SURGICAL, VISCOELASTIC

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ALCON - COUVREUR N.V./ALCON - BELGIUM DUOVISC VISCOELASTIC SYSTEM AID, SURGICAL, VISCOELASTIC Back to Search Results
Catalog Number ASKU
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Autoimmune Reaction (1733)
Event Date 04/03/2019
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 physician reported a patient experienced an immune response following a cataract extraction procedure with intraocular lens implant. The patient was treated with cortisone. Additional information has been requested but not received.

 
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Brand NameDUOVISC VISCOELASTIC SYSTEM
Type of DeviceAID, SURGICAL, VISCOELASTIC
Manufacturer (Section D)
ALCON - COUVREUR N.V./ALCON - BELGIUM
rijksweg 14
puurs B-287 0
BE B-2870
Manufacturer (Section G)
ALCON - COUVREUR N.V./ALCON - BELGIUM
rijksweg 14
puurs B-287 0
BE B-2870
Manufacturer Contact
cindy milam
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152231
MDR Report Key8703300
MDR Text Key148146178
Report Number3002037047-2019-00006
Device Sequence Number1
Product Code LZP
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberP840064
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,FOREIGN,HEALTH PROFE
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/04/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/17/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberASKU
Device LOT NumberASKU
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 Received11/19/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 06/17/2019 Patient Sequence Number: 1
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