Recent lens impact guidelines proposed by the Food and Drug Administration (FDA) would require lenses to be drop-ball tested at the place of edging. If you have an in-office finishing lab, this means that youd be required to purchase and utilize a drop-ball testing device and that youd be held liable for the ability of the lenses to pass such a test.

The proposed guidelines, first published in October 2007, recommend that lenses be drop-ball tested to determine their impact resistance. The comment period for the proposed guidance has been extended beyond the original closing date of January 24.

The major concern resulting from the proposed guidelines is the economic and practical burden it would place on the manufacturer of the lens, which the guidance defines as the person (or firm) who puts the lens in the form ready for its intended use, or who alters the physical or chemical characteristics of the lens by grinding, heating, treating, beveling, applying scratch-resistant coating, applying anti-reflective coating, cutting, or other pertinent actions. In short, this means that the facility that edges and mounts the lenses would be responsible for testing them as well.

Optical organizations think its a bad idea. There is no basis for the proposed change, says Ed Greene, chief executive officer of the Vision Council of America (VCA). The Questions and Answers (Q+A) refer to laws written when glass lenses were the majority of the market and impact resistance was a big issue.

The VCA, the Optical Laboratories Association (OLA) and the National Association of Opticianry (NAO) say that testing would cause an unnecessary bottleneck in the labs and place undue liability on the optical lab. Also, the OLA notes that the proposed testing could likely result in increased liability insurance premiums.

These organizations are attempting to compile a response to the guidelines within the extended comment period.

We are working on less confusing Q+A guidelines to suggest to the FDA after we build some industry consensus, says Mr. Greene. We want the FDA to work with the industry to publish a meaningful document that certainly does not create a negative safety issue with eyeglasses or add unnecessary costs to the distribution of eyeglasses or the equipment that produces them.

Electronic comments may be submitted at Reference docket number 2007D-0364. Or, mail comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.

Vol. No: 145:02Issue: 2/15/2008