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

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.

• Brand Name: CONTACT LENS
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• MDR Report Key: 8071205
• MDR Text Key: 127342138
• Report Number: MW5081277
• 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: Physician
• Type of Report: Initial
• Report Date: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1