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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 Problems Inflammation (1932); Toxicity (2333)
Event Date 03/27/2017
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 nurse reported that a patient presented with toxic anterior segment syndrome (tass) post operative. Additional information has bee requested, but none has been received to date.

 
Manufacturer Narrative

We have not routinely documented batch numbers with duovisc, so i am unable to ascertain which batch was associated with this surgical procedure. Batch documentation review / release results. All batches are released according to the required specifications. A lot code would be required for review of the complaint history and further evaluation. Adverse events are followed-up by medical safety. To date no complaint samples are returned for evaluation. As no sample was returned and no lot number is known, a conclusive root cause could not be determined. All batches are released according to the required specifications. (b)(4).

 
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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
nadia bailey
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152230
MDR Report Key6535205
MDR Text Key74123226
Report Number3002037047-2017-00019
Device Sequence Number1
Product Code LZP
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberP840064
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 07/31/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/01/2017
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 Received07/06/2017
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: 05/01/2017 Patient Sequence Number: 1
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