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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 Inflammation (1932); Loss of Vision (2139)
Event Date 02/21/2017
Event Type  Injury  
Manufacturer Narrative

No sample or lot number information has been received by manufacturing for evaluation. 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 lot number or complaint sample is available, retain sample testing was not performed per local procedures. As no sample was returned and no lot number is known, a conclusive root cause could not be determined. No sample is available and the lot number is unknown therefore, no conclusion can be made towards the disposition of the product. As no product is returned and/or insufficient product data is available, the complaint could not be verified therefore, no capa is initiated. Further trending is performed. (b)(4).

 
Event Description

A doctor reported that viscoelastic product was used during a cataract with intraocular lens (iol) implantation procedure. Afterwards, the patient was reported to experience progressive vision loss with toxic anterior segment syndrome (tass). Additional information has been requested.

 
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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
nadia bailey
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152230
MDR Report Key6983654
MDR Text Key90432530
Report Number3002037047-2017-00042
Device Sequence Number1
Product Code LZP
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP890047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation HEALTH PROFESSIONAL
Remedial Action Other
Type of Report Initial
Report Date 10/27/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/27/2017
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 Received10/16/2017
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: 10/27/2017 Patient Sequence Number: 1
Treatment
SN60WF 19.0S-12461045048
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