MAUDE Adverse Event Report: UNK MFR CONTACT LENSES

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Ulcer (2274)

Event Date 01/31/2017

Event Type  Injury  

Event Description

I am an optometrist and i have had several patients come in my office with infections and ulcers.These new patients were buying colored contact lenses from beauty supply stores and flea markets in the (b)(6) area.One of the stores is (b)(6) in (b)(6).They are also using fda labels on the cases to make it seem authentic.(b)(6).

• Brand Name: CONTACT LENSES
• Type of Device: CONTACT LENSES
• Manufacturer (Section D): UNK MFR
• MDR Report Key: 6300725
• MDR Text Key: 66595345
• Report Number: MW5067655
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR