National Advertising Division Recommends Johnson & Johnson Modify or Discontinue Certain Intraocular Lens Claims, Finds Other Claims Supported

For Immediate Release

Contact: Laura Brett, Director, National Advertising Division, 212.705.0109 / lbrett@bbbnp.org

New York, NY – Feb. 24, 2020 – The National Advertising Division (NAD) recommended that Johnson & Johnson Surgical Vision, Inc. (“JJSV”) modify or discontinue certain challenged claims for its TECNIS Intraocular Lenses, following a challenge by Alcon Vision, LLC, maker of the competing AcrySof line of intraocular lenses, including AcrySof IQ ReSTOR Multifocal IOLs (“ReSTOR”).  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 National Programs’ self-regulatory and dispute resolution programs.

Alcon challenged claims in JJSV’s advertising for its TECNIS IOL arguing that its advertising is misleading with respect to four properties that guide surgeons in selecting an appropriate IOL for a particular patient: image contrast, light transmission, spectacle independence, and sharpness of vision. 

The advertiser agreed to permanently discontinue an image of the AcrySof IOL that Alcon contended is outdated, a comparison of the energy distribution of its TECNIS Symfony lens “to a multifocal which splits approximately 82% of light between two focal points,” and claims that TECNIS IOLs offer the “[b]est spectacle independence in any lighting condition.” NAD, relying on JJSV’s written representations that these claims will be permanently discontinued, did not review the claims on their merits. The voluntarily discontinued claims will be treated, for compliance purposes, as though NAD recommended their discontinuance and the advertiser agreed to comply.

With regard to the challenged claims that ReSTOR lenses exhibit glistenings that “cause light scatter” and “result in a reduction of image contrast,” NAD considered the advertiser’s evidence in support of the claims, which included both laboratory studies regarding glistenings and image contrast, as well as clinical evidence on contrast sensitivity. NAD concluded that the evidence in the record established that ReSTOR IOLs exhibit glistenings, that when glistening levels reach high levels they can impact contrast sensitivity, that glistenings can worsen over time, but that evidence that the current version of ReSTOR lenses exhibit sufficient glistenings to have a statistically significant impact on contrast sensitivity was inconsistent. Thus, NAD recommended that the advertiser discontinue glistening claims that tie them to reduced image contrast or contrast sensitivity or modify its advertising to avoid conveying the message that the glistenings in ReSTOR lenses have been demonstrated to have an effect on vision. The advertiser can, however, make a more limited claim about the existence of glistenings, their impact on light scatter and otherwise explain the state of the inconsistent evidence on the impact of glistenings on contrast sensitivity.

In support of its energy distribution claim that with the TECNIS IOL “92% of light [is] transmitted across the range of vision,” the advertiser submitted its calculation of energy distribution using a diffractive theory method. Based on expert reports and other studies in the record, NAD noted that it seems clear that calculating energy distribution is accepted by experts in the field. However, it also seems clear that energy distribution can be measured, not calculated. Because the advertiser’s claim is based exclusively on calculations and not measurements, NAD recommended that the advertiser modify the claim to disclose that the energy distribution claim is based upon its calculations using the diffractive theory method.

The comparative image contrast claim that “TECNIS Symfony IOL provides improved image contrast at all pupil diameters throughout the range of vision” was modified during the course of the challenge to show the lenses being compared, the underlying data relied on, and the test method used to obtain the data. This is also accompanied by industry standard benchmark testing graphs, making clear which TECNIS Multifocal IOLs are being compared to which ReSTOR IOLs. NAD noted that the modifications will be treated, for compliance purposes, as though NAD recommended they be discontinued and the advertiser agreed to comply. Further, NAD noted that the advertising, as modified, makes clear the specific lens to which the TECNIS IOL is being compared. As a result, NAD concluded that the challenged implied overall superiority claims, “all TECNIS IOLs provide higher image contrast than all ReSTOR IOLs” and “ReSTOR IOLs do not provide adequate spectacle independence and/or provide a spectacle independence that is inferior to TECNIS IOLs” were not conveyed by the modified advertising.

Finally, NAD determined that a reasonable consumer takeaway from JJSV’s claim that TECNIS IOLs provide “the sharpest vision across all distances” is that a single patient will achieve that benefit by choosing a TECNIS IOL pair of lenses.  However, the only way for a consumer to achieve the “sharpest vision across all distances” is to combine two different lenses with the largest range of defocus curves. NAD noted that there was no evidence in the record to evaluate whether combining lenses is common and whether it involves additional tradeoffs that impact vision. Therefore, NAD recommended that the advertiser discontinue this claim or modify it to more narrowly describe the benefits provided by the line of TECNIS IOLs.

In its advertiser’s statement, JJSV took issue with some of NAD’s findings, however it agreed to comply with NAD’s recommendations.