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

Device Problems Failure To Adhere Or Bond (1031); Patient-Device Incompatibility (2682)

Patient Problems Eye Injury (1845); Pain (1994); Red Eye(s) (2038); Blurred Vision (2137); Loss of Vision (2139); Burning Sensation (2146); No Code Available (3191)

Event Date 02/19/2018

Event Type  Injury  

Event Description

I've been using hubble contacts for a while now.I've always had some issues with them staying in, but used lubricant drops to help.After long term use of your contacts, i developed a devastating major eye problem.I wasn't able to see or live my regular daily life because of the state that my eyes were in.I went to 4 different drs in a week's time, including the er at one point because of the severe pain and severe condition that my eyes were in.I lost full vision in both eyes.It was cloudy and blurry, my eyes were fire engine red for an entire week.They slung, they burned, they hurt.The light sensitivity my eyes felt was nothing like i had ever felt before.Luckily, i saw a dr that was able to get me on a very aggressive treatment once i saw her, because if it had been much longer, i don't know that i would have fully regained my vision.What bothers me the most is that you portray your company and products as fda approved and good safe products for your eyes."do you know how important your eyes are.Do you realize that i could have permanently lost my vision."i have always kept great care of my eyes, and am a very responsible contact wearer, have been for 15+ yrs.I have never had any of the issues i have encountered within the past two weeks after using hubble contacts."what plan or procedure do you have in place for a situation such as this." i don't want anyone else to ever have to deal with what i've had to deal with.It's excruciating and scary.Below are photos of my eyes, on different days over a weeks' time, and each is as painful as it looks.(b)(6).

• Brand Name: HUBBLE CONTACTS
• Type of Device: LENSES, SOFT CONTACT
• Manufacturer (Section D): HUBBLE / SHINE OPTICAL CO., LTD.
• MDR Report Key: 7344649
• MDR Text Key: 102841652
• Report Number: MW5075898
• 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: Patient
• Type of Report: Initial
• Report Date: 03/14/2018

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: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 33 YR
• Patient Weight: 73