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 CONTACT LENSES SOLUTION AND CASE; CLEAR CARE
  • 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 CONTACT LENSES SOLUTION AND CASE; CLEAR CARE Back to Search Results
Lot Number 268634F
Device Problem Device Reprocessing Problem (1091)
Patient Problems Irritation (1941); Burning Sensation (2146)
Event Date 12/29/2017
Event Type  Injury  
Event Description
I use clear care cleaning and disinfecting solution (3% hydrogen peroxide) by alcon with the special lense case included in the box to clean daily my contact lenses.The product is not always neutralized.It happens randomly.It happened twice that i burned my eyes enough that i had to wear glasses for 2 days because of irritation.I am halfway through this bottle and it probably happened 5 times that my eyes stings when i put my contact lenses.It happened also with previous bottles but this time is the worst.I never had this issue before they changed the lense case.That problem happened only with the blue and white case.Home / apartment / condominium (b)(6), this is my home address.Purchase date: (b)(6) 2017, this date is an estimate.The product was not damaged before the incident.The product was not modified before the incident.Sent an email to let them know.No reply yet.Document number: (b)(4).Report number: (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CONTACT LENSES SOLUTION AND CASE
Type of Device
CLEAR CARE
Manufacturer (Section D)
ALCON
MDR Report Key7203005
MDR Text Key97750360
Report NumberMW5074658
Device Sequence Number1
Product Code LPN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Expiration Date12/31/2018
Device Lot Number268634F
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Age43 YR
-
-