FDA Adverse Event Injury Summary report: N

MYSTERY RED CONTACT LENSES

MDR report key: 18056112 · Received November 1, 2023

Report

Report Number
MW5147624
Event Type
Injury
Date Received
November 1, 2023
Date of Event
September 1, 2023
Report Date
October 17, 2023
Manufacturer
CHENGDU AI QIN E-COMMERCE CO., LTD
Product Code
LPL
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
LA, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

TO START OFF I HAVE BEEN WEARING CONTACT SINCE 2008. I DO NOT SLEEP IN MY CONTACTS, I CHANGE MY SOLUTION AND RINSE MY CONTACT HOLDER OUT WITH DISTILLED WATER AFTER EVERY USE BEFORE REPLACING MY CONTACTS IN THEM. I ALSO "WASH MY HAND" BEFORE I PUT IN OR REMOVE MY CONTACTS. I ORDERED CONTACTS FROM TTDEYE ON (B)(6) 2023. I CALLED AND VERIFIED MY PRESCRIPTION WITH MY DOCTOR BEFORE ORDERING MY CONTACTS TO ENSURE THEY WERE GOING TO BE THE RIGHT AND VALID PRESCRIPTION STRENGTH. TTDEYE DID NOT VERIFY MY PRESCRIPTION ONLY ASKED ME FOR THE NUMBERS RELATED TO THE STRENGTH I NEEDED. THE FIRST PAIR I WORE FOR A FEW WEEK WERE NAMED MYSTERY RED AND THEY WERE UNCOMFORTABLE BUT OKAY. HOWEVER AT THE BEGINNING OF (B)(6) I TRIED TO WEAR THE COLORED ONES NAMED POLAR LIGHTS. AFTER A FEW DAYS OF WEARING THEM I STARTED GETTING SEVER IRRITATION IN MY EYES, EXTREME LIGHT SENSITIVITY AND BLURRED VISION. I TRASHED THE PAIR OF CONTACTS ASSUMING IT WAS PINK EYE DUE TO THE SEVER REDNESS IN MY EYES. I WORE MY GLASSES FOR A FEW WEEKS AND MY SYMPTOMS RESOLVED ON THEIR OWN. THIS (B)(6) I BEGAN WEARING THE COLORED PRESCRIPTION CONTACTS ICE GREEN WITHIN A FEW DAYS THE SYMPTOMS I EXPERIENCED HAD RETURNED. I KNEW THIS TIME IT WAS NOT PINK EYE. I WENT TO MY LOCAL EYE DOCTOR AND IT WAS DETERMINED THAT MY CONTACTS HAD SEVERAL SCRATCHED AND TORN THE PROTECTIVE LAYER IN MY EYE. I HAD THE CONTACTS AT MY APPOINTMENT AND IT WAS SAID THAT THEY WERE NOT THE TYPICAL SHAPE OR FINENESS YOU WOULD EXPECT FROM A GOOD PAIR OF CONTACTS. I WAS INSTRUCTED TO THROW ALL OF THE TYDEYE CONTACTS AWAY AND ENSURE. PROPER HAND WASHING TECHNIQUES AND AVOID WASHING AROUND OR TOUCHING MY EYES. I WAS ALSO ADVISED A EYE COVERING WOULD HELP ENSURE THE SAFETY OF MY EYE DURING THE HEALING PROCESS. AFTER TWO WEEKS I AM STILL HAVE SEVER EYE IRRITATION IN MY EYES AND HAVE ANOTHER EYE APPOINTMENT ON (B))(6) TO TRY AND SEE WHAT I NEED TO DO FROM HERE. I CAN BARELY SEE, GETTING OUTSIDE IN THE LIGHT MAKES ME CRY DUE TO THE SEVER IRRITATION, AND ALL I CAN SEEM TO DO IS KEEP MY EYES CLOSED. MULTIPLE OF MY FRIENDS HAVE ALSO ORDERED FROM THE SITE AROUND A TWO WEEK TIME FRAME BEFORE AND AFTER ME AND ALL HAD THE POLAR LIGHTS CONTACTS AND ARE HAVING THE SAME SYMPTOMS JUST NOT AS SEVER. I PLAN ON RETAINING A COPY OF ALL MY MEDICAL INFORMATION SURROUNDING THIS EYE INCIDENT WITH TTDEYE ON THE 27TH AND MY DOCTOR WILL BE SUBMITTING A FORM TO THE FDA AS WELL. REFERENCE REPORTS: MW5147621, MW5147622, MW5147623, MW5147625, MW5147626.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1333923 MYSTERY RED CONTACT LENSES LENSES, SOFT CONTACT, DAILY WEAR LPL CHENGDU AI QIN E-COMMERCE CO., LTD

Patients

Seq Age Sex Outcome Treatment
1 26 YR Female Other