• 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 GMBH DAILIES TOTAL 1 MULTIFOCAL 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 GMBH DAILIES TOTAL 1 MULTIFOCAL LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Catalog Number CBV92037121
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Corneal Ulcer (1796); Irritation (1941); Pain (1994)
Event Date 08/02/2019
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. (b)(4).
 
Event Description
It was reported that a consumer experienced corneal ulcer from the use of the complaint contact lenses. Additional information was received on 10aug2019 via email. It was reported that the consumer experienced difficulty on putting on the contact lenses in the left eye (os) as well as strong irritation on the eye. The problem occurred with more than 20 contact lenses and removal of the contact lenses resolved the issues. The consumer sought medical attention on (b)(6) 2019 and was diagnosed with corneal ulcers. The consumer was treated with unspecified occlusion, epithelialization and anesthetic. Additional information was received on 14aug2019. It was reported that there was no data for the location of the corneal ulcer. The consumer felt pain which was difficult to describe and the consumer had difficulty opening both eyes. The consumer felt relief after the eye care professional (ecp) applied unspecified drops and a cream. The ecp noted that the eye scarred well after the treatment and revision. Additional information has been requested but not yet received.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDAILIES TOTAL 1 MULTIFOCAL
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
CIBA VISION GMBH
postfach, industriering 1
grosswallstadt D-638 68
GM D-63868
Manufacturer (Section G)
CIBA VISION GMBH
postfach, industriering 1
grosswallstadt D-638 68
GM D-63868
Manufacturer Contact
cindy milam
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152231
MDR Report Key8934240
MDR Text Key158715559
Report Number9610813-2019-00006
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K113168
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCBV92037121
Device Lot NumberN1161266
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 Received10/30/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/16/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/27/2019 Patient Sequence Number: 1
-
-