[3410588]
Defective medical device manufactured by eagle vision. Dear sir or madam: i am writing to you about a problem i had with eagle vision's so-called dissolvable tear duct plugs. Due to a dry right eye following level 5 bell's palsy in (b)(6) 2009, i had eagle vision dissolvable tear duct plugs inserted in my upper and lower tear ducts of my right eye in (b)(6) 2010. The plug in the lower tear duct dissolved like it was supposed to, but the one in the upper tear duct did not. Because it did not dissolve, pieces of the plug became infected and also caused an abscess and two pyogenic granulomas, and required surgery to remove all of the above items. I suspected there might still be a few pieces of the undissolved plug in that tear duct because i can feel sharp pains when i gently press three different areas of that tear duct, but i have no concrete indication that there are still bits of the undissolved plug in my tear duct. I wrote eagle vision, the manufacturer of the tear duct plugs, twice about this problem. I asked eagle vision to reimburse me, my insurance carriers and my (b)(6) insurance provider for expenses of the surgery to remove the pieces of the undissolved plug, the abscess, and the two pyogenic granulomas, as well as for the pain and inconvenience the surgery caused me. In (b)(6) 2011, the top tear duct of my right eye became red, swollen and uncomfortable, and yellow pus leaked out of it many times during the day and night. When i got up in the morning, there was lots of yellow pus crusted along my eyelids and on the areas of skin above and below the edges of my eyelids. I have attached copies of those letters which were sent certified mail, e-receipt. I am also enclosing two color photos of one of the undissolved pieces of the tear duct plug removed during the surgery as well as color photo of my eye after the surgery which was done (b)(6) 2012. To date, eagle vision has not responded to my letters. I know they received my first letter because i received the (b)(6) e-receipt, plus they called my eye surgeon, dr (b)(6), within a few days after they received it. Dr (b)(6)'s assistant, (b)(6), called to let me know that. I know they received the second letter because i received the (b)(6) e-receipt which lists the date and time delivered. I am very disappointed that eagle vision might be continuing to produce and distribute so-called dissolvable tear duct plugs that do not dissolve as they are supposed to and could possibly cause eye damage to other pts. I was lucky in that, to date, there has been no permanent damage to my eye. However, the upper tear duct in my right eye has never worked correctly since their bad plug was put in. Sometimes tears from that eye run down my face copiously and i need to use drops to dry it out; sometimes that eye is dry and i need to use drops to wet it. I checked your website but was not able to find any complaints about eagle vision's dissolvable tear duct plugs. I am writing to let you know about this problem that they do not always dissolve as they are supposed to, but can stay in the tear duct area and become infected, cause abscesses, and pyogenic granulomas, all of which need to be removed during tear duct surgery. At the time of my bell's palsy and initial dissolvable plug insertion, i lived in (b)(6). However, i moved to (b)(6), in (b)(6) 2012. That is why there are different return addresses on my letters to eagle vision. I would appreciate hearing from you as to whether or not you have any authority over this type of defective medical product and could possibly contact eagle vision to find out what they have to say about this problem. (b)(6).
Patient Sequence No: 1, Text Type: D, B5