• 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 JOHOR SDN, BHD. AIR OPTIX AQUA 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 JOHOR SDN, BHD. AIR OPTIX AQUA LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Catalog Number CBV92001889
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Microcysts, Epithelial (2232)
Event Date 09/18/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). The complaint sample has not returned 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. The manufacturer internal reference number is: (b)(4).
 
Event Description
It was initially reported by the patient that there was physical damage. Additional information was received on 18oct2018 wherein the patient clarified that her physician informed her that there was an epithelial lesion on her right eye. She was prescribed with moxifloxacin hydrochloride/dexamethasone phosphate eye drops for a week. It was mentioned that the patient had recovered from the adverse event. No further information will be available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAIR OPTIX AQUA
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
CIBA VISION JOHOR SDN, BHD.
#1 dpb/5 tanjung pelepas port
gelang patah
johor darul takzim johor 81560
MY 81560
Manufacturer (Section G)
CIBA VISION JOHOR SDN, BHD.
#1 dpb/5 tanjung pelepas port
gelang patah
johor darul takzim johor 81560
MY 81560
Manufacturer Contact
cindy milam
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152230
MDR Report Key8058812
MDR Text Key126939602
Report Number3006186389-2018-00039
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K073459
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 12/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2021
Device Catalogue NumberCBV92001889
Device Lot Number10324638
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/19/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/26/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 11/12/2018 Patient Sequence Number: 1
-
-