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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Neovascularization (1978)

Event Date 04/23/2018

Event Type  Injury  

Event Description

I switched to hubble contacts approx a year and a half ago.I never wore the contacts to bed, and always used them as indicated.I went to my regular every two year eye exam and was told my eyes look like they belong to someone who sleeps in ther contacts.My vision worsened, which at my age of (b)(6), is unusual and neovascularization occurred.My optometrist recommended a year without contacts, as well as seeing an ophthalmologist to assess for the possibility of lasik surgery because he was unsure if my topography of my eyes had changed so much that i would not be a candidate for that.The ophthalmologist told me hubble has a very low oxygen permeability, and agreed that my eyes were not the best candidate for lasik.He stated i could try wearing a high quality contact less frequently.

• Brand Name: HUBBLE CONTACTS
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): ST SHINE OPTICAL CO., LTD.
• MDR Report Key: 8069002
• MDR Text Key: 127137744
• Report Number: MW5081192
• Device Sequence Number: 0
• Product Code: LPL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ESTRADIOL; SPIRINOLACTONE
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 27 YR