This article is more than 5 years old. Information may no longer be current.
Exact refraction labeling fills niche in IOL industry
Technomed has introduced a new method and philosophy of IOL labeling that challenges industry standards.
Click Here to Manage Email Alerts
Placing the exact refraction value of an IOL on its label seems like a simple change in how lenses are produced, inventoried and used, but it is a change that has recently thrust Technomed Technology, an IOL company based in Germany, into the ophthalmic industry spotlight.
With this innovative approach to the labeling and sale of Technomed’s EasyCare 600 lens, Technomed’s president, Herbert von Wallfeld, has pioneered what he considers a new philosophy in eye care.
“You read more and more articles about patient satisfaction, and it comes out finally that … [the patients] are not being satisfied with the results,” Mr. von Wallfeld told Ocular Surgery News in a phone interview. “We want to improve surgical outcomes. This is our first priority, and then handling.”
His innovation was to break away from the traditional minimum standards for refraction tolerances created by the International Standardization Organization (ISO) and the American National Standards Institute (ANSI) and to specify exact refraction values on the IOL package. Typically, this has meant that IOLs are labeled in 0.5-D steps, although recently eyeonics announced that it would label its Crystalens in 0.25-D steps.
“Manufacturers said, ‘Why should we do more than ISO and ANSI tell us,’ so they did that, until Technomed came up with the idea, well, maybe we can do a little bit more,” Mr. von Wallfeld said.
The package labels for the Technomed EasyCare 600 IOLs list both the traditional 0.5-D step values and the new more exact values, which are expressed in hundredths of a diopter.
According to Mr. von Wallfeld, he and Thomas Neuhann, MD, had been talking about this idea for a number of years, and they finally brought it to fruition about a year ago. Dr. Neuhann, however, gave the credit solely to Mr. von Wallfeld.
“[Mr. von Wallfeld’s] merit is that he immediately grasped the importance of correct labeling, and then he brought it to the market and made it available,” Dr. Neuhann said in an interview. “He knows that I know ‘ophthalmologist thinking,’ so to speak. That’s been my involvement.”
The new labeling system is currently used only with the EasyCare 600, a three-piece foldable hydrophilic acrylic IOL, but new lenses using exact labeling are expected to be available in coming months.
“I want to have single-piece lenses and three-piece lenses the same way. I think it is the first step in the right direction,” Mr. von Wallfeld said.
Manufacturing process
The precise labeling system can be used with any existing IOL with a spheric or aspheric optic, Mr. von Wallfeld said, but making the switch in the production methods takes some logistics and expense to accomplish.
“Practically everybody can do it,” he said. “If this fulfills their needs, they have the accurate machines, the precise machines to measure, if they would be willing to measure several times and would be willing to measure in water, and to make those manufacturing lines or production facilities, then practically everybody could do it.”
Mr. von Wallfeld has been working with the California-based company Tekia on the new labeling project since 2001, combining his idea for exact refraction with Tekia’s production capabilities. He chose Tekia as a partner because it is a “small newcomer company” that was poised for just such a niche market opportunity, he said.
Tekia president Gene Currie explained his interest in the project in an interview with Ocular Surgery News.
“The strategy for our company is to get into what we consider specialty products or high-value products where we do customized lenses, and we would do such things as this exact refraction value,” he said.
Tekia manufactures the EasyCare 600 lenses for Technomed using a hydrophilic acrylic material from Contamac. The lenses are measured individually rather than in a batch and in water rather than air. Each lens is measured several times for statistical accuracy.
“We have a piece of equipment that we have calibrated to within a tenth of a diopter, and then we run a little routine on it for [Technomed’s] lenses to make sure that statistically we are exactly within the tolerance on his product as we label it,” Mr. Currie explained.
According to Mr. Currie, while many larger-volume IOL companies measure lenses in a dry state, which can be less accurate, Tekia does its measurements in a specially adapted wet cell system.
Because the process is labor-intensive, the price of the lenses is about 30% more than regular lenses, he said.
“We do it because the demand is out there, and so we can charge a premium and provide a better quality product,” Mr. Currie said.
Technomed purchases the finished products from Tekia and absorbs the extra cost, selling them for the same price as other lenses, Mr. von Wallfeld said.
Breaking tradition
Dr. Neuhann said it will take a substantial shift in surgeon mentality to commit to using this new labeling system.
“It would take a new mindset,” said Dr. Neuhann, who has been using the EasyCare 600 lenses since they became available. He said he frequently catches himself asking for lenses in the traditional 0.5-D steps.
Dr. Neuhann said that, while the advantages of using exact refraction values are obvious, tradition will at first keep some ophthalmologists from making the switch.
“We are a very traditional trade, so to speak. Diopters are given in quarter-diopter steps for no obvious reason,” Dr. Neuhann said. “Because it’s untraditional, … a lens that is labeled 20.13, 20.47, 20.83 they can’t relate to.”
Other ophthalmologists in Europe and the United States have expressed interest in the concept of exact labeling. Ocular Surgery News Europe/Asia-Pacific Edition Associate Medical Editor Michael C. Knorz, MD, said that, although he has not begun using the exact refraction IOLs, he thinks it is a sensible idea.
“I think the labeling of the lens according to the real power is a very important step because it increases our confidence in the manufacturer,” Dr. Knorz said.
Mr. von Wallfeld said Technomed looks forward to introducing the new labeling concept to more ophthalmologists, but he said that a similar shift in the rest of the IOL industry may be long in coming. Large IOL companies with significant inventories of lenses measured with traditional methods could lose money on their inventories and could find themselves logistically challenged in implementing labor-intensive measuring processes like those used by Tekia.
With its ability to fill this niche in the ophthalmic industry, Mr. von Wallfeld said, Technomed finds itself in a strong position that will require care and caution to maintain.
“We are trying to get this through slowly, and [our people] are getting doctors to think about it, and more and more doctors are thinking about it,” he said.
For Your Information:
- Herbert von Wallfeld, president of Technomed, can be reached at Technomed GmbH, Arnold-Sommerfeld-Ring 1, 52499 Baesweiler, Germany; 49-2401-809-942; fax: 49-2401-8229; e-mail: Wallfeld@aol.com.
- Thomas Neuhann, MD, can be reached at Helena-Weber-Allee 19, Munich 80637, Germany; 49-89-159-31-339; fax: 49-89-1578394; e-mail: prof@neuhann.de.
- Gene Currie, president of Tekia Inc., can be reached at 17 Hammond, Suite 414, Irvine, CA 92618; 949-699-1300; fax: 949-699-1302; e-mail: gcurrie@tekia.com.
- Michael C. Knorz, MD, can be reached at Klinikum Mannheim, Theodor Kutzer Ufer 1-3, 68167 Mannheim, Germany; 49-621-383-3410; fax: 49-62-13-83-1984; e-mail: knorz@eyes.de.
- Technomed GmbH can be reached at Arnold-Sommerfeld-Ring 1, 52499 Baesweiler, Germany; 49-2401-8099-0; fax: 49-2401-8099-36; e-mail: info@tmed.de; Web site: www.tmed.de.
- Tekia Inc. can be reached at 17 Hammond, Suite 414, Irvine, CA 92618, USA, 949-699-1300; fax: 949-699-1302; Web site: www.tekia.com.
- Jared Schultz is an OSN Staff Writer who covers all aspects of ophthalmology. He focuses geographically on Europe and the Asia-Pacific region.