MAUDE Adverse Event Report: CONTACT LENSES

Device Problem Material Integrity Problem (2978)

Patient Problems Unspecified Infection (1930); Pain (1994); Visual Impairment (2138)

Event Date 07/01/2016

Event Type  Injury  

Event Description

Patient bought online cosmetic contacts to use for an event.(b)(6) after one day of wear, 90 percent of his corneal epithelium has sloughed off of his right eye resulting in 10/10 pain and severe vision decrease.He now has an infection due to the compromise of the corneal integrity.

• Brand Name: CONTACT LENSES
• Type of Device: CONTACT LENSES
• MDR Report Key: 5778346
• MDR Text Key: 49170718
• Report Number: MW5063297
• 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: 07/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 18 YR
• Patient Weight: 50