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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Neovascularization (1978)

Event Date 02/13/2020

Event Type  Injury  

Event Description

Pt wears hubble contact lenses.Came in with neovascularization of the cornea due to 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
• MDR Report Key: 9728830
• MDR Text Key: 180362639
• Report Number: MW5093073
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/18/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR
• Patient Weight: 91