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

Device Problem Product Quality Problem (1506)

Patient Problems Corneal Scar (1793); Corneal Ulcer (1796); Unspecified Infection (1930)

Event Date 08/09/2021

Event Type  Injury  

Event Description

The patient was wearing hubble contacts and due to the lack of oxygen transmissibility through the lens material to the patient's eye, she developed an infectious corneal ulcer and has a permanent corneal scar in the center of her vision that cannot be improved with other refractive means.Oxygen transmissibility (dk/t) in contact lenses is measured in a lab and is given a value.Most standard contact lenses prescribed by an eye care provider have a dk/t value of at least 80, sometimes 100 or higher.Hubble contacts are made with a material that has a dk/t value of 18.This means it does not transmit oxygen through the contact to the eye very well at all.This is unsafe and not recommended as a standard of care in contact lens prescribing.This type of adverse event can leave a patient with permanent vision loss and have a very direct negative impact on quality of life, like it did with my patient.Fda safety report id# (b)(4).

• Brand Name: HUBBLE CONTACTS
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): HUBBLE / ST. SHINE OPTICAL CO., LTD.
• MDR Report Key: 12406191
• MDR Text Key: 269545106
• Report Number: MW5103628
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• 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): Disability
• Patient Age: 42 YR
• Patient Weight: 50