MAUDE Adverse Event Report: ART OPTICAL CONTACT LENS RIGID GAS PERMEABLE CONTACTS; LENS, CONTACT (RIGID GAS PERMEABLE)

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/20/2020

Event Type  malfunction  

Event Description

New rigid gas permeable lens right contact marking vanished, i was told i had to redo it with a sharpie myself, i did, twice and it vanishes.Apparently, it could be tattooed and inked permanently (as all my previous pairs of 45 years of wearing them have been).I am required to pay (b)(6) to ship and cover the cost.These cost me (b)(6) out of pocket and my expectation is they last for years and are not defective.I would like the vendor, art optical to remedy the situation and cover the cost.Neither my eye doctor or art optical will help.I called (b)(6) to complain and they said they could not talk to me directly.Please advise? thanks for your assistance.Fda safety report id # (b)(4).

• Brand Name: RIGID GAS PERMEABLE CONTACTS
• Type of Device: LENS, CONTACT (RIGID GAS PERMEABLE)
• Manufacturer (Section D): ART OPTICAL CONTACT LENS
• MDR Report Key: 9632236
• MDR Text Key: 176665767
• Report Number: MW5092506
• Device Sequence Number: 1
• Product Code: MWL
• 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: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/24/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61`