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

MAUDE Adverse Event Report: ALCON RESEARCH, LLC DAILIES TOTAL 1 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
 

ALCON RESEARCH, LLC DAILIES TOTAL 1 LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Catalog Number CBV92004051
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Corneal Scar (1793); Keratitis (1944); Pain (1994); Ulcer (2274)
Event Date 02/05/2019
Event Type  Injury  
Manufacturer Narrative
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
As initially reported on (b)(6) 2019 by the patient who had a very serious bacterial keratitis while wearing the contact lens. The patient woke up with a very painful eye on (b)(6) 2019 and was diagnosed by an eye care provider (ecp) on (b)(6) 2019 with a severe bacterial keratitis. The ecp informed that it was an opportunistic organism that penetrated into the stroma of the cornea, forming an ulcer and created a small scar. The ecp treated it with moxifloxacin, treatment duration and modality was not specified and used a soft contact lens as bandage lens. The patient was using loteprednol cortisone drops for the next two weeks until the next follow up check up. The infection was completely cleared. Additional information was received via email from the patient on (b)(6) 2019, informing that the patient stopped using moxifloxacin as there was no more infection present. The patient had been wearing spectacles only. Additional information has been requested but not yet received.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDAILIES TOTAL 1
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
ALCON RESEARCH, LLC
11440 johns creek parkway
duluth GA 30097
Manufacturer (Section G)
ALCON RESEARCH, LLC
11440 johns creek parkway
duluth GA 30097
Manufacturer Contact
cindy milam
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152231
MDR Report Key8418029
MDR Text Key138768134
Report Number1065835-2019-00004
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
K113168
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 04/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2021
Device Catalogue NumberCBV92004051
Device Lot NumberA5043375
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/15/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/17/2018
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: 03/13/2019 Patient Sequence Number: 1
-
-