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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. SHINE OPTICAL CO., LTD. HUBBLE SOFT CONTACT LENS

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ST. SHINE OPTICAL CO., LTD. HUBBLE SOFT CONTACT LENS Back to Search Results
Lot Number UNKNOWN
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Neovascularization (1978)
Event Date 03/05/2019
Event Type  Injury  
Manufacturer Narrative
The lot number is unknown and the products are not made available for evaluation at this time. The information about patient and initial reporter as well as other information required to submit was not provided. If the additional information is received, the follow-up report will be submitted within 30 days of the receipt. Subsequent actions regarding the follow-up report will be taken and submitted in accordance with 21 cfr 803. 10 and 803. 56.
 
Event Description
The following information was obtained when searching the maude database on apr. 08, 2019. Report number: mw5084733. The event description was: "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
Type of DeviceSOFT CONTACT LENS
Manufacturer (Section D)
ST. SHINE OPTICAL CO., LTD.
4,5 f/l no. 276-2 sec. 1
tatung rd., hsi chih dist.,
new taipei city, 221
TW 221
Manufacturer Contact
jeremy lin
4,5 f/l no. 276-2 sec. 1
tatung rd., hsi chih dist.,
new taipei city, 221
TW   221
MDR Report Key8584961
MDR Text Key144245880
Report Number9617499-2019-00006
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
PMA/PMN Number
K121201
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/08/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 05/06/2019 Patient Sequence Number: 1
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