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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DREAM EYES CONTACTS

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DREAM EYES CONTACTS Back to Search Results
Lot Number 6A1K041W00
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem Discomfort (2330)
Event Date 10/30/2018
Event Type  malfunction  
Event Description
I recently bought halloween contacts from a website called (b)(6) it says they are fda approved on the website, but they never asked for my prescription. I did some research after purchasing and trying them on myself. That's when i read that it is illegal to not ask for a prescription. The contact did not fit my eye properly and caused discomfort even after removing. (b)(6).
 
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Brand NameDREAM EYES CONTACTS
Type of DeviceDREAM EYES CONTACTS
MDR Report Key8028420
MDR Text Key126070076
Report NumberMW5080991
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 10/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2021
Device Lot Number6A1K041W00
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
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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