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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 04/28/2016
Event Type  Injury  
Manufacturer Narrative

All batches are released according to the required specifications. A lot code would be required for review of the complaint history and further evaluation. As no sample was returned and no manufacturing related issues were identified, a conclusive root cause could not be determined. A potential root cause of the adverse event related complaint include a solution quality issue, but this is unlikely; chemistry and microbiology data must met requirements prior to release of product. (b)(4).

 
Event Description

A nurse reported multiple patients presented with tass (toxic anterior segment syndrome) following phacoemulsification procedures. The patient this report represents presented with excessive inflammation (2+ cells and 1+ fibrin) in the anterior chamber on post-operative day #1. The frequency of use for the patient's steroidal drops were increased in proportion to the degree of inflammation observed. This is the sixth of thirteen reports being filed for this facility.

 
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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
eddie darton, md, jd
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8175686660
MDR Report Key5801317
MDR Text Key49753820
Report Number3002037047-2016-00133
Device Sequence Number1
Product Code LZP
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberP840064
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN
Reporter Occupation
Type of Report Initial
Report Date 07/16/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/16/2016
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 Received06/16/2016
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? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/16/2016 Patient Sequence Number: 1
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