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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 Problems Expiration Date Error (2528); Patient-Device Incompatibility (2682)
Patient Problem No Information (3190)
Event Date 12/21/2018
Event Type  Injury  
Event Description
Clarity and clarity toric contact lenses were prescribed and the patient received hubble spherical in both eyes. In addition, the prescribing doctor received a verification fax which she promptly responded to stating the prescription was expired and it was for different material. She additionally called the line for customer service and verbally stated the prescription was incorrect and asked for a call back. Although the voicemail machine said they would get back to her within 48 hours, they never did. Despite all that effort, the patient received the hubble contacts and now has corneal neovascularization (a corneal condition which develops when there is a lack of oxygen), which was never previous documented.
 
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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 Key8196088
MDR Text Key131762867
Report NumberMW5082556
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 Other Health Care Professional
Type of Report Initial
Report Date 12/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
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

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