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U.S. Department of Health and Human Services

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

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ST. SHINE OPTICAL HUBBLE CONTACT LENSES LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Neovascularization (1978)
Event Date 02/13/2020
Event Type  Injury  
Event Description
Pt wears hubble contact lenses. Came in with neovascularization of the cornea due to contact lenses. Fda safety report id# (b)(4).
 
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Brand NameHUBBLE CONTACT LENSES
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
ST. SHINE OPTICAL
MDR Report Key9728830
MDR Text Key180362639
Report NumberMW5093073
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 02/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2020
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: 02/18/2020 Patient Sequence Number: 1
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