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U.S. Department of Health and Human Services

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

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ST SHINE OPTICAL CO., LTD. HUBBLE CONTACTS LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Neovascularization (1978)
Event Date 04/23/2018
Event Type  Injury  
Event Description
I switched to hubble contacts approx a year and a half ago. I never wore the contacts to bed, and always used them as indicated. I went to my regular every two year eye exam and was told my eyes look like they belong to someone who sleeps in ther contacts. My vision worsened, which at my age of (b)(6), is unusual and neovascularization occurred. My optometrist recommended a year without contacts, as well as seeing an ophthalmologist to assess for the possibility of lasik surgery because he was unsure if my topography of my eyes had changed so much that i would not be a candidate for that. The ophthalmologist told me hubble has a very low oxygen permeability, and agreed that my eyes were not the best candidate for lasik. He stated i could try wearing a high quality contact less frequently.
 
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Brand NameHUBBLE CONTACTS
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
ST SHINE OPTICAL CO., LTD.
MDR Report Key8069002
MDR Text Key127137744
Report NumberMW5081192
Device Sequence Number0
Product Code LPL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 11/13/2018 Patient Sequence Number: 1
Treatment
ESTRADIOL; SPIRINOLACTONE
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