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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONTACT LENS LENSES, SOFT CONTACT, DAILY WEAR

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CONTACT LENS LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Device Problem Expiration Date Error (2528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/01/2018
Event Type  No Answer Provided  
Event Description
Again had a patient who purchased contact lenses via (b)(6) and was able to purchase contacts past the expiration date. An illegal act according to the fda. I hope there are serious discussions about the illegal practice of these online contact lens companies. They are being allowed to harm patients with potential serious sight threatening actions. By the fda and bbb setting on hands, they are enabling and taking part of the illegal actions. With the use of devices eyeballs are becoming dryer quicker in life and this will become a serious issue and cause patients to lose eyesight with the lack of care by online companies. Contact lenses are medical devices and being treated as a novelty. I take pride in keeping patients' eyeballs healthy. This is equivalent to letting patients reorder opioids from online retailer. I don't think you would let that happen. Please take into consideration the safety of peoples eyesball health.
 
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Brand NameCONTACT LENS
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
MDR Report Key8071205
MDR Text Key127342138
Report NumberMW5081277
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
Type of Report Initial
Report Date 11/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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