MAUDE Adverse Event Report: QUALIMED SRL DESIO; LENSES, SOFT CONTACT, DAILY WEAR

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dry Eye(s) (1814); Eye Injury (1845); Unspecified Infection (1930); Inflammation (1932); Irritation (1941); Red Eye(s) (2038)

Event Date 03/31/2018

Event Type  Injury  

Event Description

Reporter purchased color contact lenses online for cosmetic use without a required prescription.She reports eye irritation, dryness, soreness and redness immediately after use.About 4 months later of intermittent use she has an eye infection and inflammation in both eyes.She has stopped using the contacts and is now on antibiotics for the infection.

• Brand Name: DESIO
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): QUALIMED SRL
• MDR Report Key: 7568726
• MDR Text Key: 110205513
• Report Number: MW5077620
• 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: Patient
• Type of Report: Initial
• Report Date: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1