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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 Patient-Device Incompatibility (2682)
Patient Problems Conjunctivitis (1784); Erythema (1840); Irritation (1941); Blurred Vision (2137)
Event Date 12/29/2017
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 the other information required to submit were 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 (b)(6) 2018. Report number: mw5074358. The event description was: "pt presented today with complaints of redness, ocular irritation, and blurred vision in his right eye. Examination confirmed an acute conjunctivitis in both eyes, which was worse in the right eye. Pt had been prescribed biotrue daily disposable contact lenses in (b)(6) 2017. However, 3 months ago, he successfully filled and was dispensed hubble contact lenses online, without any verification with our office (in spite of pt's report that he entered dr and office info). Pt's ocular condition is a direct result of the hubble contact lenses which he was not prescribed. The material, base curve, diameter, and other parameters all differ significantly from his prescribed contact lenses. ".
 
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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 Key7410423
MDR Text Key104921559
Report Number9617499-2018-00001
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 Received04/09/2018
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 Received02/12/2018
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: 04/09/2018 Patient Sequence Number: 1
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