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Symfony availability

Now that Symfony is FDA approved, is there any information about when it will actually become available for U.S. patients?

For me, the question isn't just academic. I'm scheduled for measurements Aug. 1, then eye one a week later, and eye 2 about a week after that. On my last visit, a week ago, just days before the FDA announcement, I discussed Symfony in passing with my ophthalmologist. The conversation went something like this: "Sounds like great option. Too bad it's not available." And he went on to recommend the Tecnis low add (+2.75).

I was ecstatic (not too strong a word) when I saw the FDA announcement Friday. Having learned of (and so much about) the Symfony from SoftwareDeveloper's posts, I've considered it the ideal lens for me, and even entertained the idea of traveling to get it. (The Tecnis +2.75 was an acceptable second place choice, and until Friday was a default first choice due only to uncertainty about Symfony availability. I'm in front of several monitors all day and so very concerned about intermediate vision--that, and the reduced glare/haloes and increased contrast sensitivity, are why I'm so interested in the Symfony.)

This week I spoke with the ophthalmologist's scheduler, who said she was told by an AMO rep that the lens would be rolled out "in the fall." She suggested I could get my measurements done Aug. 1 as scheduled, and then possibly wait a few months, if necessary/desired, for the Symfony to become available.

On a related note, has anyone seen documentation of the FDA study referenced in the approval? I have searched at the FDA
site but with no luck.
Best Answer
Avatar universal
When the low add tecnis multifocal IOLs got approved in Dec 2014 it appears it took around 4-5 months for them to be available to the public based on FDA MAUDE data. I imagine  the symfony IOL will be rolled out around October so Abbott can maximize the profits from the IOLs in the 4th quarter.

As for the FDA data the only working link so far is:  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P980040S065 but the Clinical Trials link goes to a unapproved trial. The data probably still needs to be processed for online viewing.
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webdev-
Not sure you saw my answer about how to get a lens NOW without looking for a test participant.  I had my first Symfony done in the US 9/13/16. See my prior answer for details.  Meanwhile, my sight is doing great with the -12 lens. Best vision of my life!
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177275 tn?1511755244
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Avatar universal
I had my first Symfony lens inserted 9/13/16. If they are not readily available in your area, ask your doc to call his Abbott rep.  My dr made that call for me and my lenses were hand delivered before they were in full stocking and distribution mode.  I chose my doc because he has a lot of experience with AMO lenses - no learning curve for insertion or measurements. I'm in the Los Angeles area.

According to the registration card,my first lens was -12 (myopia, presbyopia and less than 1 diopter of astig).

It has been 48 hours since cataract surgery and I can already use my 13" laptop comfortably at any location between 10 - 16".  My vision isn't completely settled yet. I think the UHD screen is helping with its high contrast.  I have slightly less reading range with paper documents.  The 40" bedroom TV is clear enough to read all text easily except the "racing feed" in small type at the bottom of weather and news; 14'distance.  I haven't tried driving today.  Yesterday I could see my instruments clearly but not the nav or street signs without squinting.  Doc plans to use laser to fine-tune the astig.
You're gonna love this lens!
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Avatar universal
I haven't read through it, but the FDA page about the Symfony:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P980040S065

seems to have been updated with information about the Symfony clinical trials, its in the document linked to   giving the summary of safety and effectiveness (and perhaps in the label links also, I hadn't checked those). Again, I hadn't read through it to examine how much detail they give in the "summary", but they had a fair amount in the comparable documents for the Tecnis and Restor low add multifocals I'd looked at in the past.  The "clinical trial" link still goes to a page without any actual data.
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A quick check shows the European studies seemed to indicate slightly better results, this indicates for instance that there may be some slight reduction in contrast sensitivity whereas other studies didn't show it. It isn't clear if its a statistical glitch or indicates perhaps a slight difference that isn't always picked up in studies. For perspective, here is a short video interview of an American surgeon talking about data from all the studies:

http://ewreplay.org/node/1216?v=4884644449001

For comparision, here is the FDA data from the Restor +2.5 approval:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P040020S050

where the Alcon monofocal control seems to have more halo issues (but the studies may not be directly comparable since the wording of questions and methodology may vary).

Here is the FDA approval for the Tecnis low add multifocals (+2.75 and +3.25):

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P980040S049



Avatar universal
Thanks, except. Not the answer I was hoping for, but makes sense.
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Avatar universal
rwbil, Is there a way to determine which doctors participated, so I could find one near me?
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177275 tn?1511755244
That is as good as estimate as any.
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you might check with the doctors who participated in the trial and see if they have access
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177275 tn?1511755244
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