http://www.accessdata.fda.gov/scripts/c ... _ID=853673
Hello, this letter is in regards to the staar visian icl -pma #p030016-. I had a visian lens implanted in my left eye in 2007. That evening, i noticed some strange halo/ starbursts surrounding light sources -e. G. Car headlights-. The visual artifacts look like two thirds of a spoked wheel surrounding every light. The image i see contains many -hundreds- of fairly well defined lines radiating from the light source. The lines terminate at a fairly well defined edge, where the edge itself is a well defined bright line. Also, there is a protruding secondary image from the primary image. The result is an image that looks a lot like a snow angle, where the head is the light source. At about one week post op, i visited the doctor and he gave me an eye exam, and corrected my remaining astigmatism using that test lens device they use for figuring out one's prescription. The good news was that my vision was 20/30 after correcting for my astigmatism. The bad news was that the visual artifacts were still there. They seemed unrelated to my astigmatism. My doctor consulted with a staar field representative, and both the doctor and the staar representative concluded that the vault of the icl was too high, and the icl should be replaced with a smaller version. They suspected that the high vault of the icl was causing the visual artifacts. Fourteen days later, my doctor preformed a second procedure to replace the icl with a smaller lens. That evening, i checked my vision, and unfortunately, the visual artifacts were still there. They were just as big and bright as before. My doctor tells me that the icl has excellent placement, and the vault looks great. He preformed a wave front analysis, and my cornea looks fine. A pentacam exam didn't reveal anything unusual. He doesn't know what is wrong. I got a second opinion from another ophthalmologist, but he also concluded that the implant was properly installed. I've contacted the staar company, and have worked with them somewhat to determine the problem. I've had conversations with their head of qa as well as with dr head of r&d i believe- and the inventor of the lens, but they do not know what is wrong. A note on staar. The people at staar have been somewhat repsonsive. They are not proactive about solving my problem. I initially started sending an email to them, but got no response. After two weeks i called them. I did not receive a call within two weeks, so i called them again. I got the email address of the head of qa and sent her my information and requested help. I got a reply saying that they would get back to me in a few days. I waited a week, but did not hear back. A week and a half after that qa replied. She set up a phone conference between me and the drs. A few days later, we had the phone conference. We talked for about 30 minutes, but were unable to determine the cause of my problem. They requested the results from my cornea mapping. I sent the information to them within a day or two. I've some additional information on the exact optical diameter of my lens, but i have not received a reply in over 2 months. I've also sent a letter. My opinion of the staar company is marginal at best. There customer service doesn't seem very good, and i'm surprised they do not wish to follow up on a possible problem with a product. I was/am an excellent candidate for implantation of the staar visian lens. My eyes pre-op had the following prescription: right= -16d x 2. 25d x 108, left = -18d x -1. 75d x 065. Both my pupils dilated to about 5. 75 mm. My best corrected vision was 20/40. Like many people, my pupils are off center and are somewhat nasal. I suspect i fall into a minority or patients that have an unacceptable result with the optical diameter of the staar visian lens. That is, the labeling of the staar lens states that the optical diameter of the lens is between 4. 9 and 5. 8 mm. Since my prescription is high, i'm guessing the optical diameter of my lens is closer to the lower number -i. E. 4. 9-. My dilated pupil diameter is larger, and therefore unfocused light enters my eye under low light situations. In conclusion, i would suggest the fda expand the pt criteria suitability for implantation of the staar visian lens to wear in low light conditions where the diameter of the optical portion of the lens would be such that pts would recognize visual problems in low light. In this way, pts that have problems can be disqualified from the procedure. I would also like to recommend that the labeling of the visian lens be changed to specify the exact optical diameter of each lens. That is, the range currently given -i. E. 4. 9 to 5. 8- is not precise enough. An exact diameter would give useful information. Finally, i would greatly appreciate it if the fda could contact the staar company and suggest they continue to investigate my visual problems. I've contacted other staar patients, that suffer similarly.
