Eyeworld Supplements

1974–1980s SUPPLEMENT TO EYEWORLD | 17 removal of IOLs from the market "would be a massive tragedy" for patients and that "to classify the intraocular lenses as a 'new drug' is bureaucracy gone mad." Dr. Hirschman and Dr. Michelis ultimately prevailed with Los Angeles Superior Court Judge Harry Hupp on August 22, 1975, granting a temporary restraining order against the prohibition of the manufacture, sale, and use of IOLs in the state. "at temporary restraining order still stands today; the state never filed an appeal," Dr. Hoffer said. While this battle was won, the use of IOLs was still not entirely protected. e next big battle was around the corner. e U.S. FDA gained greater regulatory author- ity over implantable devices in 1976 with the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act signed by President Gerald Ford. In these amendments, IOLs were originally to be banned until one could be FDA approved. Dr. Michelis helped lead a lawsuit against the state of Cal- ifornia to protect the right of ophthalmologists to use IOLs. Source: ASCRS Video Temporary restraining order against the prohibition of the manufacture, sale, and use of IOLs in California. Source: Kenneth J. Hoffer, MD First challenge faced ASCRS leads defense of IOLs One of AIOIS' pivotal accomplishments—that affected the future for cataract surgeons, patients, and innova- tors—came close on the heels of the Society's founding. In 1975, the California FDA sought to classify IOLs as a drug. Dr. Hoffer recalled getting a letter from the Califor- nia FDA in June 1975 that immediately banned the manufacture and implantation of IOLs in the state. An emergency meeting of AIOIS was called. e So- ciety hired attorney John Martzell, who evaluated the situation and recommended that they attempt to get a restraining order using local attorneys. Dr. Hoffer and Dr. Jaffe coordinated a "battle plan." Attorneys Ted Pulaski and Alex McDonald were hired by the newly formed Lens Implant Defense Fund that had been privately established. With Dr. Hirschman and Mary Kay Michelis, MD, as plaintiffs, a lawsuit was filed against the state. In a publication celebrating the 25th anniversary of ASCRS, Dr. Michelis said that she had become "con- cerned about my ability to provide patients with what I considered to be the best medical care." She said, "We had to fight." In a newspaper article, Dr. Jaffe said that e FDA report on intraocular lenses e FDA report on intraocular lenses, pub- lished by Stark et al., 1 described the data collected on more than 1 million IOLs that were considered investigational devices be- tween February 1978–August 1982. e report found that visual acuity of 20/40 or better at 1-year postop was achieved in 85% of more than 45,000 cases that were re- viewed. e first IOL to receive FDA final approval was the Choyce Mark VIII anterior chamber lens. REFERENCE 1. Stark WJ, et al. e FDA report on intraocular lenses. Ophthalmology. 1983 Apr. 90;4:311–317.

• Cover