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

Device Problem Use of Device Problem (1670)

Patient Problem Eye Infections (4466)

Event Date 03/31/2022

Event Type  Injury  

Event Description

Bacterial infection due to soft contact lens wear from an improperly fit soft contact lens which was never prescribed to the patient.The patient reports wearing hubble contacts consistently over the past four years.By his report, he has not seen an eye care provider in over four years.The fellow eye has been blind for decades due to an unrelated injury.If he loses vision due to this infection, it has the potential to severely affect his quality of life and ability to work.Fda safety report id# (b)(4).

• Brand Name: HUBBLE CONTACTS
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): ST. SHINE OPTICAL CO., LTD.
• MDR Report Key: 14014855
• MDR Text Key: 288673920
• Report Number: MW5108754
• 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: Physician
• Type of Report: Initial
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White