IN EARLY 1971, Bausch + Lomb was granted the first U.S. Food and Drug Administration (FDA) approval to manufacture and market soft contact lenses in the U.S. Over the next eight years, other products entered the soft lens marketplace, such as Softcon and AOSoft from American Optical in 1973, Hydrocurve (Continuous Curve) in 1974, Aquaflex (Cooper Labs) in 1975, Durasoft (Wesley Jessen) and Permalens (Global Vision) in 1978, and Hydron (American Hydron) and Flexlens (Flexlens) in 1979 (Bowden, 2009).

Except for Softcon, which was approved exclusively for therapeutic applications, all of these lenses shared a similar FDA approval for correction of normal refractive errors. There was one notable exception to this: Flexlens, a small company in Columbus, OH.

The authors recently interviewed Arch Holcomb, one of the original employees at Flexlens, who described some of the interesting history of the lens:

“In January 1979, Flexlens received FDA approval to manufacture soft contact lenses designed for ‘any atypical ametropias with either normal or abnormal refractive errors.’ This unique approval allowed Flexlens to manufacture soft lenses in any base curve, power, diameter, thickness, or design. This was the first (and subsequently only) such approval ever granted by the FDA for a soft contact lens. Gaining this approval with such wide parameter availability surprised all of us at Flexlens.

Flexlens was started in 1972 by founder Richard (Dick) Lindmark, who began fabricating custom soft contact lenses at home for his patients with special ocular needs. Lindmark and four investors—Joseph Bitonte, Bud Thoma, Gerald Feldman, and Rush Hilborn—hired me and Nancy Holcomb to begin the long seven-year process of compiling clinical data for FDA approval.

Following their 1979 approval, we began manufacturing soft contact lenses for pediatric and adult aphakia, high pathologic myopia, post-refractive surgery, macro- and microcorneas, piggyback lenses, and mega-lenses (19.5mm and 22.0mm) for sealing leaking blebs following glaucoma filtering procedures.

Looking back, it was an astonishing achievement to manufacture such complex lens designs as they were fabricated on primitive, hand-operated Levin (Levin and Sons) and Hardinge (Hardinge Brothers Inc.) lathes that were already outdated methods for lathing contact lenses.

The material at the time was a 45% water HEMA hefilcon A plastic, manufactured by polymer chemist pioneer William (Bill) Hoffman of Optacryl Inc. in Colorado.

We made some wild lenses at this time, such as the –41.00D, provided to the authors and shown here (Figure 1). We also made some innovative keratoconus soft lenses as well at a time when no one else was doing so. The company later relocated to New Mexico, then was purchased by Paragon Vision Sciences and others, then ultimately sold to its present owner, X-Cel Contact Lens.”

Flexlens has withstood the test of time. It’s important in our contact lens history, as it established the basis for today’s custom soft contact lens market throughout the world.

Additionally, it showed how a handful of dedicated people can overcome significant obstacles to create a 44-year-old company that (with the exception of Bausch + Lomb) has outlasted the companies that received FDA approvals in the 1970s.

The authors wish to thank Arch and Nancy Holcomb for providing us with their oral history of Flexlens and the early days of custom soft contact lenses. CLS

References

1. Bowden TJ. Contact Lenses the Story: A Historical Development of Contact Lenses. 2009. Bower House Publications.