MAUDE Adverse Event Report: HUBBLE / ST. SHINE OPTICAL CO., LTD. HUBBLE CONTACT LENSES; LENSES, SOFT CONTACT, DAILY WEAR

Device Problem Nonstandard Device (1420)

Patient Problem Neovascularization (1978)

Event Date 03/05/2019

Event Type  Injury  

Event Description

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.

• Brand Name: HUBBLE CONTACT LENSES
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): HUBBLE / ST. SHINE OPTICAL CO., LTD.
• MDR Report Key: 8403348
• MDR Text Key: 138350054
• Report Number: MW5084733
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 54 YR