MAUDE Adverse Event Report: ST. SHINE OPTICAL CO., LTD HUBBLE; SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

Device Problem Insufficient Information (3190)

Patient Problem Eye Infections (4466)

Event Type  Injury  

Manufacturer Narrative

This medical device reporting (mdr) submission is late due to the esg account creation taking a while to get reviewed and the test submission fully verified by the fda.This is vision path's first mdr submission for this year.

Event Description

The patient alleges that, after using the suspect medical device sometime in (b)(6) 2021, she "immediately felt like she was getting an infection, possibly pink eye." upon visiting the doctor, the patient was allegedly informed that she had a waterborne bacterial infection on her eye.The patient further alleges that she was diagnosed with a pseudomona infection that was aggressive, resistant to antibiotics, and that led to a corneal ulcer, and ultimately blindness, in her right eye.The patient attributes these events to her use of the suspect medical device.The circumstances surrounding this event do not allow for our firm to investigate and obtain further information regarding this event.Infections are a known and disclosed risk of contact lens wear.However; there are numerous potential causes of the event described by the patient.Our firm has no evidence to substantiate the patient's allegations, and in particular her attribution of the event she experienced to the suspect medical device.At the time of this report, our firm is unable to access information regarding the medical status of the patient prior to the event, the manner with which the device was used, the diagnosis from a medical professional, clinical course and treatments, and confirmation of the clinical outcome.

• Brand Name: HUBBLE
• Type of Device: SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
• Manufacturer (Section D): ST. SHINE OPTICAL CO., LTD; 4, 5f, no. 276-2, sec 1, ta tu; new taipei, 221 ; TW 221
• MDR Report Key: 15496957
• MDR Text Key: 300703534
• Report Number: 3012421058-2022-00001
• Device Sequence Number: 1
• Product Code: MVN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2022
• 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
• Distributor Facility Aware Date: 08/19/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Sex: Female