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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. SHINE OPTICAL CO., LTD. HUBBLE CONTACT LENSES LENSES, SOFT CONTACT, DAILY WEAR

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ST. SHINE OPTICAL CO., LTD. HUBBLE CONTACT LENSES LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Discomfort (2330)
Event Date 03/26/2021
Event Type  No Answer Provided  
Event Description
Patient reports purchasing hubble contact lenses from their website without being asked for any prescription in (b)(6) 2021. No significant damage to ocular health was present but patient admits to being surprised no prescription was needed and reports poor comfort in them.
 
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Brand NameHUBBLE CONTACT LENSES
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
ST. SHINE OPTICAL CO., LTD.
MDR Report Key11664031
MDR Text Key245578203
Report NumberMW5100764
Device Sequence Number1
Product Code LPL
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
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

Patient Treatment Data
Date Received: 04/13/2021 Patient Sequence Number: 1
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