• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Problem Neovascularization (1978)
Event Date 12/21/2018
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 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 jan. 14, 2019. Report number: mw5082556. The event description was: "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. ".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key8338040
MDR Text Key136115597
Report Number9617499-2019-00003
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 Received02/13/2019
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 Received01/14/2019
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: 02/13/2019 Patient Sequence Number: 1
-
-