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

MAUDE Adverse Event Report: UNKNOWN BRAND COLORED CONTACTS CONTACT LENSES

  • 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
 

UNKNOWN BRAND COLORED CONTACTS CONTACT LENSES Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Corneal Ulcer (1796)
Event Date 06/12/2014
Event Type  Injury  
Event Description

Pt purchased colored contact lenses over the counter from a beauty supply store, which resulted in bilateral corneal ulcers, which may lead to permanent vision damage. Unk brand of over the counter purchased, non prescription, colored contact lenses. Dates of use: few months. Diagnosis or reason for use: changing appearance of eye color.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN BRAND COLORED CONTACTS
Type of DeviceCONTACT LENSES
MDR Report Key3880275
MDR Text Key4569957
Report NumberMW5036644
Device Sequence Number1
Product Code LPL
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 06/12/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/13/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes

Patient TREATMENT DATA
Date Received: 06/13/2014 Patient Sequence Number: 1
-
-