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U.S. Department of Health and Human Services

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

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ALCON - COUVREUR N.V./ALCON - BELGIUM VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE AID, SURGICAL, VISCOELASTIC Back to Search Results
Catalog Number 160909000J
Device Problem Detachment Of Device Component (1104)
Patient Problems Intraocular Pressure Increased (1937); Device Embedded In Tissue or Plaque (3165)
Event Date 06/08/2016
Event Type  Injury  
Manufacturer Narrative

No sample or lot number information has been received by manufacturing for evaluation. 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. Additional information has been requested. (b)(4).

 
Event Description

A doctor reported that viscoelastic product was retained in the patient's eye following cataract surgery due to an unstable anterior chamber. The patient has experienced elevated intraocular pressure which has not resolved after two weeks. Additional information has been requested.

 
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Brand NameVISCOAT 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
eddie darton, md, jd
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8175686660
MDR Report Key5778941
MDR Text Key49068906
Report Number3002037047-2016-00114
Device Sequence Number1
Product Code LZP
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberP840064
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation HEALTH PROFESSIONAL
Remedial Action Other
Type of Report Initial
Report Date 07/08/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/08/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number160909000J
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 Received06/21/2016
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: 07/08/2016 Patient Sequence Number: 1
Treatment
AMO TORIC LENS
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