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

MAUDE Adverse Event Report: 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
 

CONTACT LENSES Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Conjunctivitis (1784); Corneal Edema (1791); Neovascularization (1978)
Event Date 12/03/2013
Event Type  Injury  
Event Description

This pt states ordered contact lenses from 1800 contact lenses. She states that she was able to purchase the contact lenses for the last 7 years without a valid prescription. The pt has corneal edema (eye swelling), which is preventing her from seeing 20/20. She has corneal neovascularization and giant papillary conjunctivitis.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCONTACT LENSES
Type of DeviceCONTACT LENSES
MDR Report Key3535876
MDR Text Key4114614
Report NumberMW5033569
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 12/17/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/18/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator
Is The Reporter A Health Professional? Yes

Patient TREATMENT DATA
Date Received: 12/18/2013 Patient Sequence Number: 1
-
-