MAUDE Adverse Event Report: UNKNOWN BRAND COLORED CONTACTS; CONTACT LENSES

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.

• Brand Name: UNKNOWN BRAND COLORED CONTACTS
• Type of Device: CONTACT LENSES
• MDR Report Key: 3880275
• MDR Text Key: 4569957
• Report Number: MW5036644
• Device Sequence Number: 1
• Product Code: LPL
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/13/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR