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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 960571CO-001
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Inflammation (1932); Reaction (2414)
Event Type  Injury  
Manufacturer Narrative

No other complaints were reported for this lot. All batches are released according to the required specifications and all initial testing results are within specification (ph and osmo are within specifications). A complaint sample, one carton with insert and unopened sterile package with viscoat and provisc syringes, were received. The lab has retested the complaint sample: all results are conform to the specifications for the tested parameters for both viscoat and provisc (ph and osmo conform). In addition, the lab has retested the reference sample of this batch: all results are conform to the specifications for the tested parameters for both viscoat and provisc (ph and osmo conform). As the complaint sample and retain sample was conforming and all initial testing results are within specification, a conclusive root cause could not be determined for the inflammation. The manufacturer internal reference number is: (b)(4).

 
Event Description

A nurse manager reported 8 patients who had inflammatory reactions after cataract extraction procedures. The site is currently investigating the possible causes of the inflammation and have found that the common factor in them all is the use of duovisc. All patients are being treated with anti-inflammatory therapy. Additional information has been requested.

 
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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
rita lopez
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8175514846
MDR Report Key6438137
MDR Text Key70972652
Report Number3002037047-2017-00015
Device Sequence Number1
Product Code LZP
Combination Product (Y/N)N
Reporter Country CodeCO
PMA/PMN NumberP840064
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 03/28/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/28/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2018
Device Catalogue Number960571CO-001
Device LOT Number16A11TA
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/04/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/06/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/11/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 03/28/2017 Patient Sequence Number: 1
Treatment
BSS BAG 500ML
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