MAUDE Adverse Event Report: OBED HOLDINGS CORP HD2O SILICONE HYDROGEL SOFT CONTACT LENS; LENSES, SOFT CONTACT, DAILY WEAR

Lot Number 399932

Device Problems Product Quality Problem (1506); Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2021

Event Type  malfunction  

Event Description

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).

• Brand Name: HD2O SILICONE HYDROGEL SOFT CONTACT LENS
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): OBED HOLDINGS CORP; 2674 barnet hwy; coquitlam, bc V3B 1 B9; CA V3B 1B9
• MDR Report Key: 13059886
• MDR Text Key: 282716443
• Report Number: MW5106200
• 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: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 12/31/2023
• Device Lot Number: 399932
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White