BBB National Programs Archive
NAD Recommends Alcon Vision Discontinue Certain Challenged Claims in Professional Advertising for Intraocular Lenses, Finds Certain Claims Supported
New York, NY – Nov. 7, 2019 – The National Advertising Division recommended that Alcon Vision, LLC discontinue certain challenged claims in professional advertising for its AcrySof IQ ReSTOR +2.5 D and +3.0 D Multifocal Intraocular Lenses, following a challenge by Johnson & Johnson Surgical Vision, Inc. (“JJSV”), maker of competing TECNIS Symfony intraocular lenses. Intraocular lenses (“IOLs”) are implantable medical devices that surgeons use to replace patients’ natural lenses after they are removed during cataract surgery.
NAD is an investigative unit of the advertising industry’s system of self-regulation and is a division of the BBB NP’s self-regulatory and dispute resolution programs.
The claims challenged by JJSV appeared in a sales aid and comparative chart directed to eyecare professionals and included:
- TECNIS Symfony provides “81% of energy to the eye.”
- TECNIS Symfony has an Add Power of +1.75 D.
- TECNIS Symfony has a “Central Portion” that is “Intermediate”.
- TECNIS Symfony has an “Energy Distribution” total of 81.0% (distributing 40.5% to “Distance” and 40.5% to “Intermediate”), in contrast to supposedly higher “Energy Distribution” totals of 84.5% (distributing 59% to “Distance” and 25.5% to “Near”) and 87.4% (distributing 69.4% to “Distance” and 18% to “Near”) for ReSTOR +3.0 D and ReSTOR +2.5 D, respectively.
- TECNIS Symfony is a multifocal IOL, as opposed to a unique and revolutionary FDA-approved EDOF.
- TECNIS Symfony is inferior for near vision type activities compared to ReSTOR +2.5 D and +3.0 D because TECNIS Symfony supposedly has a very low Add power of +1.75 D, which is significantly less than the Add powers of +2.5 D and +3.0 D that are specified for the advertised Alcon ReSTOR lenses.
The claims at issue in this challenge relate to JJSV’s TECNIS Symfony IOL, which belongs in a relatively new category called extended depth of focus (“EDOF”) lenses. The parties dispute the extent to which EDOF technology overlaps with and diverges from existing multifocal lens technology, and NAD had to resolve whether the challenged advertising conveys unsupported messages regarding the add power, central portion, and energy distribution properties of JJSV’s TECNIS Symfony lens.
NAD considered the reasonable takeaway from Alcon’s claims that JJSV’s TECNIS Symfony lens has an add power of +1.75 D, which appeared in a chart comparing aspects of two Alcon ReSTOR multifocal offerings against the TECNIS Symfony lens, and in a sales aid graphic which listed the lenses by their brand name followed by their respective add powers. An add power provides standard information to eyecare professionals about the power a lens provides to allow for clear vision at a close range. NAD concluded that the challenged advertising conveys the message that the add power assigned to the TECNIS Symfony lens is an accepted technical measure, similar to the add power assigned to multifocal IOLs, and as such can be readily compared to the add power for the Alcon ReSTOR lenses. However, such a message was unsupported because the add power for TECNIS Symfony lenses is not required by the FDA and the evidence established that an EDOF, which transmits light over a range of distances, performs differently than a multifocal lens. Further, NAD determined that Alcon’s evidence did not provide a reasonable basis for its claims that the TECNIS Symfony lens performs like a multifocal lens with a +1.75 D add power and recommended that the claims be discontinued.
However, NAD concluded that the challenged advertising did not convey an implied message that the TECNIS Symfony is a multifocal IOL or – with NAD’s recommendation to discontinue the +1.75 D add power claim – that the TECNIS Symfony is inferior for near vision activities.
Further, NAD determined that Alcon provided a reasonable basis for its claim in the comparative chart that the “central portion” of the TECNIS Symfony lens is “intermediate,” but recommended that the advertiser modify the chart to clarify that the “central portion is intermediate” is not a characterization provided by JJSV and to more clearly disclose the basis for the claim (i.e. Alcon’s measurements of the geometry of the lens). NAD concluded that because this metric appears to directly relate to the structural characteristics of the lens, reliance on objective measurements such as Alcon’s measurements of the lens’s geometry was sufficient.
Finally, NAD concluded that Alcon did not have a reasonable basis for its energy distribution claims that the TECNIS Symfony lens provides 81% of energy to the eye, and recommended that these claims be discontinued. NAD was concerned that the advertiser’s energy distribution did not account for energy distributed to the near focus, when FDA has confirmed that EDOF lenses such as the TECNIS Symfony “provide a continuous range of relatively clear vision, beyond that achievable with a monofocal lens.”
In its advertiser’s statement, Alcon stated that it “supports the self-regulatory process and will comply with the recommendations laid out in NAD’s decision.”