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

Lot Number 217326

Device Problem Material Integrity Problem (2978)

Patient Problem Pain (1994)

Event Date 04/12/2018

Event Type  malfunction  

Event Description

This actually happened to several days and attempts.I tried wearing hubble contacts and every time i put them in, they hurt my eye.I thought it was just that my eyes needed to get used to them.They're dailies, but i tried 12 in one eye one day and they all hurt.I'm a nurse and fairly observant because i have to be objective in my profession.The contacts are not uniform in thickness.They vary, and i can tell because some of them were so thin they were collapsing themselves before i even put them in my eye.Then one day i held one on my finger as i was driving.I wanted to put it in at the next stoplight.What i noticed was that after a min, the contact started to shrivel.After another few mins, it dried out so much that it was fairly hard.So i put 2 and 2 together.I realized that they do not hold moisture well and the moisture wicks out of them, even when in your eye.I tested several and left them in my eye and they were hurting my eye each and every time.And each of the contacts i took out had shriveled slightly creating a fold in the contact that pokes at your eye.Please test this to ensure it's not happening to other people.A contact lens product should not be drying out while in a consumer's eye, causing the contact to poke at the eye.Also i checked, and during my trials, i had used contacts from 3 different lots.So i feel this is a widespread issue and because the contact is inconsistent and the integrity of the contact is too easily compromised, i believe it should not be sold to consumers, and because it may potentially scratch someone's cornea, or perhaps something worse.I feel this should immediately be looked into.I don't know if contacts are approved by the fda, but i have no idea how the original samples could have passed testing if fda approval is required.Thank you.

• Brand Name: DAILY CONTACT LENS
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): HUBBLE/ST. SHINE OPTICAL CO., LTD.
• MDR Report Key: 7446420
• MDR Text Key: 106199606
• Report Number: MW5076579
• 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: 04/18/2018
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/31/2022
• Device Lot Number: 217326
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 64