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

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Visual Impairment (2138)

Event Date 07/30/2021

Event Type  Injury  

Event Description

Hubble contacts has failed to deliver my contacts for over 30 days, and now i've run out of contacts and cannot legally drive.They charged me again for this month, when i still haven't received last months.I can't leave my house because i don't have any contacts.Fda safety report id # (b)(4).

• Brand Name: CONTACTS
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): ST. SHINE OPTICAL CO., LTD.
• MDR Report Key: 12266826
• MDR Text Key: 265000771
• Report Number: MW5102944
• Device Sequence Number: 1
• Product Code: LPL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/02/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR
• Patient Weight: 83