MAUDE Adverse Event Report: ST. SHINE OPTICAL CO., LTD. HUBBLE; SOFT CONTACT LENS

Lot Number UNKNOWN

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

Patient Problems Pain (1994); Increased Sensitivity (2065); Blurred Vision (2137); Loss of Vision (2139)

Event Date 02/19/2018

Event Type  Injury  

Manufacturer Narrative

The lot number is unknown and the products are not made available for evaluation at this time.The information about initial reporter and the other information required to submit was not provided.If the additional information is received, the follow-up report will be submitted within 30 days of the receipt.Subsequent actions regarding the follow-up report will be taken and submitted in accordance with 21 cfr 803.10 and 803.56.

Event Description

The following information was obtained through medwatch report.Report number: mw5075898.The event description was: "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
• Type of Device: SOFT CONTACT LENS
• Manufacturer (Section D): ST. SHINE OPTICAL CO., LTD.; 4,5 f/l no. 276-2 sec. 1; tatung rd., hsi chih dist.,; new taipei city, 221 ; TW 221
• Manufacturer Contact: jeremy lin ; 4,5 f/l no. 276-2 sec. 1; tatung rd., hsi chih dist.,; new taipei city, 221 ; TW 221
• MDR Report Key: 7457300
• MDR Text Key: 106383571
• Report Number: 9617499-2018-00004
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• PMA/PMN Number: K121201
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention