Premium Intraocular Lens Expert Witness

Premium lens cases differ from other cataract claims in one respect that shapes everything else: the patient bought something. There was a recommendation, a price, a promise or the impression of one, and a signed financial agreement. The eye may measure 20/20 and the patient may still be unhappy, and both facts can be true at once.

What makes a lens "premium"

Medicare and most insurers pay for cataract surgery with a conventional single-focus lens. Under two rulings of the Centers for Medicare and Medicaid Services, a patient may choose a presbyopia-correcting lens (one designed to give a range of focus) or an astigmatism-correcting toric lens and pay the portion of the charges that exceeds the charge for a conventional lens. The extra payment is lawful, and it also means the selection conversation, the marketing material and the financial paperwork are part of the medical record that an expert should read.

Why patients are dissatisfied

Two published series of dissatisfied multifocal lens patients reached consistent conclusions. Blurred vision was the leading complaint, followed by photic phenomena such as halos and glare. The most frequent causes were residual refractive error and astigmatism, clouding of the capsule behind the lens (posterior capsule opacification), dry eye and a large pupil. Most were treatable: in one series 84 percent of eyes were amenable to therapy and lens exchange was needed in 4 percent, and in the other 81 percent improved with conservative treatment and 7 percent required exchange.

The lesson for litigation is that dissatisfaction is usually a problem with an identifiable cause. The standard-of-care question is whether the surgeon looked for that cause and treated it in a sensible order.

Recurring allegations

• Patient selection. Multifocal optics divide light and reduce contrast, so an eye with macular disease, glaucoma, an irregular cornea, prior refractive surgery or significant dry eye is a poor candidate. The chart should show that the macula and the corneal shape were examined before the lens was recommended, typically with OCT (optical coherence tomography) and corneal topography.
• Refractive miss. The lens power left the patient nearsighted, farsighted or astigmatic. The analysis runs through the measurements and the formula, as described at Refractive Error After Cataract Surgery.
• Toric lens errors. A toric lens corrects astigmatism only when it sits on the intended axis. Claims involve marking errors, a lens implanted on the wrong axis, rotation after surgery, and delay in repositioning a rotated lens.
• Handling of the unhappy patient. One of the cited series concluded that laser capsulotomy should be delayed until it is clear that the lens will not need to be exchanged, because opening the capsule makes a later exchange more difficult. A capsulotomy performed early, followed by a difficult exchange, is a recognizable fact pattern.
• Consent and marketing. Whether halos, glare and reduced contrast were disclosed; whether a single-focus lens or monovision was offered as an alternative; and whether brochures, websites or staff promised freedom from glasses. See Informed Consent in Eye Surgery.
• Billing. Whether the charges matched what the federal rulings permit, particularly where a laser fee was added. See Laser-Assisted Cataract Surgery.

The records that matter

The biometry and calculation sheets; corneal topography or tomography; the preoperative macular OCT; the note documenting the lens discussion; the premium lens consent and the financial agreement; any marketing material given to the patient; the implant sticker identifying model and power; the operative note, including the intended toric axis; and every postoperative refraction, topography and dilated examination documenting where the lens sits. Complications of the lens itself, such as dislocation, are covered at Intraocular Lens Complications.

Causation

Three explanations compete in most cases. The symptoms may be inherent to the lens design, in which case the issue is selection and consent. They may arise from a treatable cause such as residual astigmatism, capsule clouding or dry eye, in which case the issue is postoperative management. Or they may come from disease the eye already had, in which case the issue is whether it was detectable beforehand. A useful test is to ask what the patient would be experiencing with a conventional lens in the same eye. Dr. Shomer addresses each explanation separately and says which the records support.

Lens exchange

Replacing a premium lens with a conventional one usually resolves optical symptoms inherent to the design. It is also a second intraocular operation with its own risks, which rise once the lens has scarred into the capsule or the capsule has been opened by laser. Both the decision to exchange and the decision to wait can be reasonable, and the timing of each step is where the reviewable judgments lie.

Frequently Asked Questions

Authorities Cited

Primary sources referenced on this page. Links open the source on the publisher’s or agency’s site.

• de Vries NE, Webers CAB, Touwslager WRH, et al. Dissatisfaction after implantation of multifocal intraocular lenses. J Cataract Refract Surg. 2011;37(5):859-865
• Woodward MA, Randleman JB, Stulting RD. Dissatisfaction after multifocal intraocular lens implantation. J Cataract Refract Surg. 2009;35(6):992-997
• CMS Ruling 05-01, Requirements for Determining Coverage of Presbyopia-Correcting Intraocular Lenses (May 3, 2005)
• CMS Ruling CMS-1536-R, Requirements for Determining Coverage of Astigmatism-Correcting Intraocular Lenses (January 22, 2007)
• American Academy of Ophthalmology, Cataract in the Adult Eye Preferred Practice Pattern