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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Corneal Abrasion (1789)

Event Date 03/10/2022

Event Type  Injury  

Event Description

Patient is using hubble contact lenses since 2018 with no updated prescription.Patient now has damage to the cornea of both eyes.Hubble has been violating online sales of contact lenses in a variety of ways.Bilateral corneal neovascularization.Fda safety report id # (b)(4).

• Brand Name: HUBBLE CONTACT LENSES
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): ST. SHINE OPTICAL CO., LTD.
• MDR Report Key: 13757389
• MDR Text Key: 287246667
• Report Number: MW5108108
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Prefer Not To Disclose
• Patient Race: White