MAUDE Adverse Event Report: WESLEY JESSEN CORP FRESHTONE CONTACTS; CONTACT LENSES

Device Problem Material Integrity Problem (2978)

Patient Problem Eye Injury (1845)

Event Date 05/30/2016

Event Type  Injury  

Event Description

Purchased non prescription lenses from (b)(6) and initially after inserting the lenses, (b)(6), my eyes started to burn the following morning, i woke up with both eyes shut.Seller said his contacts do not require prescription and work on all eyes.

• Brand Name: FRESHTONE CONTACTS
• Type of Device: CONTACT LENSES
• Manufacturer (Section D): WESLEY JESSEN CORP
• MDR Report Key: 5707094
• MDR Text Key: 46859500
• Report Number: MW5062737
• Device Sequence Number: 1
• Product Code: LPL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Weight: 64