FDA Adverse Event Malfunction Summary report: N

HD2O SILICONE HYDROGEL SOFT CONTACT LENS

MDR report key: 13059886 · Received December 20, 2021

Report

Report Number
MW5106200
Event Type
Malfunction
Date Received
December 20, 2021
Date of Event
October 20, 2021
Report Date
December 17, 2021
Manufacturer
OBED HOLDINGS CORP
Product Code
LPL
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
IL, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

I ORDERED CONTACT LENSES FROM (B)(6) (MANUFACTURED BY OBED HOLDINGS CORP). THE CONTACT LENS BOX DOESN'T SAY THE MATERIAL OF THE LENSES, OR WHERE THEY ARE MADE. IT ONLY INCLUDES INSTRUCTIONS AND THE MANUFACTURER NAME & ADDRESS (WHICH IS AN ADDRESS FOR ORDER FULFILLMENT, NOT A FACTORY ADDRESS). I TRIED WEARING THESE CONTACTS AND DIDN'T LIKE THE QUALITY OF THEM. TODAY ON (B)(6), THE COMPANY ADMITTED THAT THEIR CONTACT LENSES ARE NOT FDA APPROVED. I HAVE SEEN DOZENS OF ADS FOR THEIR PRODUCTS ON (B)(6) AND (B)(6), AND EVEN ON (B)(6). THEY ARE ADVERTISING THESE PRODUCTS TO US CONSUMERS EVEN THOUGH THEY ARE NOT FDA APPROVED. I HOPE THAT THIS REPORT WILL SPUR THE FDA TO ACTION AND RESULT IN THIS COMPANY BEING FORCED TO STOP SELLING THESE ILLEGAL, NON-FDA APPROVED CONTACT LENSES. ACCORDING TO THE PRODUCT WEBSITE (B)(6) THE PRODUCTS ARE BEING SOLD BY DR. (B)(6), WHO ALSO OWNS (B)(6), WHICH IS A CHAIN OF LOCATIONS IN (B)(6). THE LOCATION ON THE BOX WAS (B)(6). I ALSO HAVE FILED SEVERAL COMPLAINTS WITH THE (B)(6) ABOUT THIS COMPANY NOT PROPERLY VERIFYING PRESCRIPTIONS. THOSE COMPLAINT NUMBERS ARE (B)(4). FDA SAFETY REPORT ID# (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1946455 HD2O SILICONE HYDROGEL SOFT CONTACT LENS LENSES, SOFT CONTACT, DAILY WEAR LPL OBED HOLDINGS CORP 399932

Patients

Seq Age Sex Outcome Treatment
1 28 YR Male