• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CIBA VISION CORPORATION DAILIES AQUACOMFORT PLUS; LENSES, SOFT CONTACT, DAILY WEAR

  • 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
 

CIBA VISION CORPORATION DAILIES AQUACOMFORT PLUS; LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Catalog Number CBVUNK00012
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Ulcer (2274)
Event Type  Injury  
Manufacturer Narrative
The lot number was not provided and the complaint sample was not made available for evaluation.The manufacturing review did not indicate that this complaint was due to the manufacturing process.No complaint or manufacturing trend was identified.The root cause could not be determined.(b)(4).
 
Event Description
It was initially reported on 27mar2018 by the optician to sales representative following an incident presented by a male patient with 'ulcer on left eye (os).' at the time of the report, the patient's eye status is unknown.No further information is available at this time.Additional information was requested but not yet received.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DAILIES AQUACOMFORT PLUS
Type of Device
LENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
CIBA VISION CORPORATION
11460 johns creek parkway
duluth GA 30097
Manufacturer (Section G)
CIBA VISION CORPORATION
11460 johns creek parkway
duluth GA 30097
Manufacturer Contact
bryan blake
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152230
MDR Report Key7452193
MDR Text Key106215396
Report Number1065835-2018-00005
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K072777
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Health Professional
Type of Report Initial
Report Date 04/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Catalogue NumberCBVUNK00012
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/27/2018
Initial Date FDA Received04/23/2018
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 N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age37 YR
-
-