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U.S. Department of Health and Human Services

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

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QUALIMED SRL DESIO LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
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.
 
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Brand NameDESIO
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
QUALIMED SRL
MDR Report Key7568726
MDR Text Key110205513
Report NumberMW5077620
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received06/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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