Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ALCON - COUVREUR N.V./ALCON - BELGIUM PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; AID, SURGICAL, VISCOELASTIC Back to Search Results
Catalog Number ASKU
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Uveitis (2122)
Event Date 05/13/2018
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 physician has reported that two patients have presented with uveitis post cataract surgery.Additional information has been requested but not received.
 
Manufacturer Narrative
The initial decision to report was incorrect resulting in the initial report being submitted in error.  this report does not meet criteria for reporting as a serious injury.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
Type of Device
AID, SURGICAL, VISCOELASTIC
Manufacturer (Section D)
ALCON - COUVREUR N.V./ALCON - BELGIUM
rijksweg 14
puurs B-287 0
BE  B-2870
MDR Report Key7568561
MDR Text Key110045132
Report Number3002037047-2018-00010
Device Sequence Number1
Product Code LZP
Combination Product (y/n)N
PMA/PMN Number
P890047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Catalogue NumberASKU
Device Lot NumberASKU
Was Device Available for Evaluation? No
Date Manufacturer Received08/06/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CUSTOM PAK; UNSPECIFIED VISCOELASTIC; CUSTOM PAK; UNSPECIFIED VISCOELASTIC
Patient Outcome(s) Other; Required Intervention;
-
-