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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON - COUVREUR N.V./ALCON - BELGIUM PROVISC OPHTHALMIC VISCOSURGICAL DEVICE AID, SURGICAL, VISCOELASTIC

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ALCON - COUVREUR N.V./ALCON - BELGIUM PROVISC OPHTHALMIC VISCOSURGICAL DEVICE AID, SURGICAL, VISCOELASTIC Back to Search Results
Catalog Number ASKU
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Toxicity (2333); Reaction (2414)
Event Date 10/17/2014
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 consumer reported experiencing toxic anterior segment syndrome / non-infectious endophthalmitis as a reaction to the viscoelastic material used during phacoemulsification surgery. Medical records provided by the consumer indicated that the same event was experienced by two additional patients who underwent phacoemulsification surgery at the same facility. This is one of three reports being filed for this facility. This report is for the first of the two additional patients. The alcon reference numbers are 2016-54156, 2016-54162 and 2016-54164.

 
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Brand NamePROVISC OPHTHALMIC VISCOSURGICAL DEVICE
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
rita lopez
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8175514846
MDR Report Key5834872
MDR Text Key50816369
Report Number3002037047-2016-00145
Device Sequence Number1
Product Code LZP
Combination Product (Y/N)N
Reporter Country CodeGR
PMA/PMN NumberP890047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 07/29/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/29/2016
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 Received07/01/2016
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?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/29/2016 Patient Sequence Number: 1
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