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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Red Eye(s) (2038); Visual Impairment (2138); Discomfort (2330)
Event Date 09/21/2020
Event Type  Injury  
Manufacturer Narrative
The lot number is unknown and the products are not made available for evaluation at this time. Our distributor contacted the initial reporter to obtain the additional information via email and phone, however, there's no additional information 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 oct. 08, 2020. Report number: mw5096834. The event description was: "contact lenses illegally sold online without proper fitting or evaluation. Patient acquired discomfort and contact lens associated red eye with reduced acuity. Fda safety report id# (b)(4). ".
 
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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 Key10799074
MDR Text Key215041216
Report Number9617499-2020-00003
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121201
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2020
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
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/08/2020
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: 11/06/2020 Patient Sequence Number: 1
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