MAUDE Adverse Event Report: CONTACT LENS; LENSES SOFT CONTACT DAILY WEAR

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Corneal Ulcer (1796); Discomfort (2330)

Event Date 09/05/2018

Event Type  Injury  

Event Description

Contact lens related corneal ulcer.Contact related irritation 1 day prior.Pt went to bed that evening and then slept in contact lenses until 1 am when he awoke due to increased discomfort.Removed contact lenses at 1 am.Discomfort persisted and worsened throughout early morning so presented to office after awakening.Was diagnosed with corneal ulcer.

• Brand Name: CONTACT LENS
• Type of Device: LENSES SOFT CONTACT DAILY WEAR
• MDR Report Key: 7869351
• MDR Text Key: 120191734
• Report Number: MW5079760
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 38 YR