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

MAUDE Adverse Event Report: M.I. CONTACT CO LTD MAGIC COLORED 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
 

M.I. CONTACT CO LTD MAGIC COLORED CONTACT LENSES Back to Search Results
Lot Number VEC12112301
Device Problem Nonstandard Device (1420)
Patient Problem Bacterial Infection (1735)
Event Date 02/11/2013
Event Type  Injury  
Event Description

Decorative contact lens related - corneal ulcer/abrasion pt was (b)(6) female. Pt initially seen at optometrist office. Both eyes were affected. Presented with an epithelial defect of 80% both eyes. The lenses were bought online. No prescription used. The pt wore the contacts for 4 days and removed at night. First time contact lens wearer. Was followed by an optometrist for routine exams prior to this episode. The pt did not use any other solutions than the solution the contacts came in. Unsure of what internet website/address was used to purchase lenses. The lenses had a artificial colored aqua iris. The brand printed on the contact lens vial was "magic". They were shipped from (b)(4). The contents list: one sterile hydrophilic contact lens 62% polymacon, 38% water immersed in a buggered isotonic saline solution. "buggered was spelled out this way instead of buffered. " (b)(4). Dates of use: (b)(6) 2013 - (b)(6) 2013. Diagnosis or reason for use: cosmetic.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMAGIC
Type of DeviceCOLORED CONTACT LENSES
Manufacturer (Section D)
M.I. CONTACT CO LTD
factory world,
332-2 woncheon-dong, yeaongton
suwan-si, kyeonggi-do
KS
MDR Report Key2999559
MDR Text Key3353935
Report NumberMW5029280
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
Type of Report Initial
Report Date 03/05/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/05/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device LOT NumberVEC12112301
OTHER Device ID Number15.11.22. 12.11.23. ISO13485.9
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes

Patient TREATMENT DATA
Date Received: 03/05/2013 Patient Sequence Number: 1
-
-