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U.S. Department of Health and Human Services

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

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OBED HOLDINGS CORP HD2O SILICONE HYDROGEL SOFT CONTACT LENS LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
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).
 
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Brand NameHD2O SILICONE HYDROGEL SOFT CONTACT LENS
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
OBED HOLDINGS CORP
2674 barnet hwy
coquitlam, bc V3B 1 B9
CA V3B 1B9
MDR Report Key13059886
MDR Text Key282716443
Report NumberMW5106200
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received12/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Lot Number399932
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided

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