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U.S. Department of Health and Human Services

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

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HUBBLE / ST. SHINE OPTICAL CO., LTD. HUBBLE CONTACT LENSES LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Device Problem Nonstandard Device (1420)
Patient Problem Neovascularization (1978)
Event Date 03/05/2019
Event Type  Injury  
Event Description
Patient ordered hubble daily use contact lenses online and without a prescription (which is illegal, the company is in violation providing her a supply). She presented for examination yesterday with clinically significant neovascularization on the cornea 360 degrees in both eyes. In order to prevent further damage, the patient had to be fitted in special contact lenses with significantly improved oxygen permeability. These complications could have led to permanent damage of vision if the patient had not presented to the clinic today. Patient had previously worn prescribed daily-use contact lenses which were evaluated and determined to be safe to wear by a licensed optometrist, with no difficulties or adverse effects.
 
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Brand NameHUBBLE CONTACT LENSES
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
HUBBLE / ST. SHINE OPTICAL CO., LTD.
MDR Report Key8403348
MDR Text Key138350054
Report NumberMW5084733
Device Sequence Number1
Product Code LPL
Combination Product (y/n)Y
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 03/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2019
Is this an Adverse Event Report? Yes
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: 03/07/2019 Patient Sequence Number: 1
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