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

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Loss of Vision (2139)

Event Date 04/28/2021

Event Type  Injury  

Event Description

Vision loss caused by abuse of illegally purchased contact lenses.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: 11824855
• MDR Text Key: 250838737
• Report Number: MW5101341
• Device Sequence Number: 1
• Product Code: LPL
• 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: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 33 YR
• Patient Weight: 105