The Food and Drug Administration yesterday "strongly recommended" but did not demand recall of a brand of plastic lenses that had to be surgically removed from 30 patients in whose eyes they were implanted.
The Surgidev Corp. of Santa Barbara, Calif., began selling its "Style 8 Anterior Chamber Lens" in April, 1976, to replace natural lenses removed from cataract victims. Physicians implanted them in about 1,000 patients.
About 6,600 more lenses are in the hands of physicians or hospitals, or in the supply pipeline.
Three weeks ago, the company told the FDA's Bureau of Medical Devices that it knew of significant adverse effects in 98 of the 1,000 users, including 30 in which surgical removal was necessary. Some users suffered decreased vision.
As a result, the company notified hospitals and physicians on June 24 that it had "temporarily discontinued" distribution of the lenses and requested them to stop implanting the devices and to "closely monitor" patients fitted with them.
Contending that this action was insufficient, the Health Research Group, which is financed by Ralph Nader's Public Citizen, Inc., yesterday requested FDA Commissioner Donald Kennedy to compel Surgidev to recall the unused 6,600 lenses and to require that users be asked to seek examinations for possible eye damage.
The FDA said it "strongly recommended" but did not insist upon the recall, mainly because it hasn't determined whether changes in the lenses or in the instructions for implanting them could solve the problem.
The company has termed a recall "unwarranted." Dr. Sidney M. Wolfe, director of Health Research, accused the FDA of having "yielded."
The agency also said it will contact all 604 hospitals and doctors who have implanted the lenses to be sure they have received a June 24 company advisory letter and are aware of the hazards.
The FDA learned of the problem when Surgidev president Myron E. Lippman reported in a May 19 letter that a single physician had removed, months after implantation. Style 8 lenses from five patients who had developed adverse reactions "which he was unable to get under control." The letter said that a second doctor had 10 problem patients and a third had about 11 who had suffered "mini-hemorrhages."