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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Conjunctivitis (1784); Inflammation (1932); Keratitis (1944); Scar Tissue (2060); Loss of Vision (2139)

Event Date 01/19/2022

Event Type  Injury  

Event Description

Patient ordered contacts off of (b)(6) to wear and this led to ocular inflammation which could lead to scarring and vision loss.Eye exam showed severe corneal and conjunctival inflammation from contact lens use.Fda safety report id # (b)(4).

Event Description

Patient ordered contacts off of (b)(6) to wear and this led to ocular inflammation which could lead to scarring and vision loss.Eye exam showed severe corneal and conjunctival inflammation from contact lens use.Fda safety report id # (b)(4).

• Brand Name: HUBBLE CONTACTS
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): HUBBLE CONTACTS/VISION PATH, INC/ST. SHINE OPTICAL CO., LTD
• MDR Report Key: 13479906
• MDR Text Key: 285431314
• Report Number: MW5107278
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/03/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Other