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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 Pain (1994); Increased Sensitivity (2065); Blurred Vision (2137); Loss of Vision (2139)
Event Date 02/19/2018
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 initial reporter and the 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 through medwatch report. Report number: mw5075898. The event description was: "i've been using hubble contacts for a while now. I've always had some issues with them staying in, but used lubricant drops to help. After long term use of your contacts, i developed a devastating major eye problem. I wasn't able to see or live my regular daily life because of the state that my eyes were in. I went to 4 different drs in a week's time, including the er at one point because of the severe pain and severe condition that my eyes were in. I lost full vision in both eyes. It was cloudy and blurry, my eyes were fire engine red for an entire week. They slung, they burned, they hurt. The light sensitivity my eyes felt was nothing like i had ever felt before. Luckily, i saw a dr that was able to get me on a very aggressive treatment once i saw her, because if it had been much longer, i don't know that i would have fully regained my vision. What bothers me the most is that you portray your company and products as fda approved and good safe products for your eyes. "do you know how important your eyes are. Do you realize that i could have permanently lost my vision. "i have always kept great care of my eyes, and am a very responsible contact wearer, have been for 15+ yrs. I have never had any of the issues i have encountered within the past two weeks after using hubble contacts. "what plan or procedure do you have in place for a situation such as this. " i don't want anyone else to ever have to deal with what i've had to deal with. It's excruciating and scary. Below are photos of my eyes, on different days over a weeks' time, and each is as painful as it looks. (b)(6). ".
 
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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 Key7457300
MDR Text Key106383571
Report Number9617499-2018-00004
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 Received04/25/2018
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? No
Event Location No Information
Date Manufacturer Received04/03/2018
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: 04/25/2018 Patient Sequence Number: 1
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