Eight patients in a Minnesota hospital who had cataract surgery and implantation of an intra-ocular lens prosthesis on November 10 or 11, 1976, developed endophthalmitis. All patients had received lenses from a single lot of a single manufacturer. Pseudomonas aeruginosa was subsequently isolated from 2 patients' eyes and from unused lenses of the same lot. The manufacturer has voluntarily recalled all lenses released after November 5, 1976.

Disease became apparent between 24 and 48 hours following operation and was characterized by brown pupillary light reflex, corneal clouding, and, in 4 patients, by coagulum or hypopion in the anterior chamber. No patient complained of increased pain, and the maximum temperature of any patient was 100 F. Needle aspirations obtained from vitreous fluid of 2 patients grew P. aeruginosa sensitive to gentamicin, tobramycin, colistin, and carbenicillin.

An epidemiologic investigation revealed that all 8 lenses were from lot # 76-285 produced by the Copeland Lens Company, New York City. Two control groups of uninfected patients were evaluated: (1) 15 other patients receiving Copeland lenses October 24-November 8, 1976, and (2) 21 patients operated on in the same period receiving prosthestic lenses from other manufacturers. No other patients received lenses from lot # 76-285. Six of 8 affected patients were operated on by a single surgeon, but that surgeon inserted approximately half of all Copeland lenses in the insitution (p = 0.2). Other than exposure to lenses from lot # 76-285, there were no significant differences between the case and control groups in terms of underlying illnesses, age, sex, or types of preoperative, intraoperative, or postoperative care.

Patients were initially treated with topical and systemic antimicrobials and corticosteroids. When the identity of the infecting microorganism was discovered, gentamicin was administered parenterally, and by either subconjunctival or sub-tenon injection. In addition, parenteral carbenicillin and high dose prednisone therapy was initiated. One lens had to be removed to control infection, but 7 patients are improving on chemotherapy. At least 5 of the 8 patients are expected to suffer no impairment of vision.

Four unopened lenses from the suspect lot were available in the hospital. Three lenses were aseptically removed from their containers and cultured; each grew P. aeruginosa with the same antimicrobial susceptibility pattern as that causing disease. The fourth lens was subsequently cultured by the Food and Drug Administration and was found to be contaminated with P. aeruginosa.

Distribution records of the suspect lot were obtained from the manufacturer. Of 97 lenses in the lot, all were recovered except 12 that already had been implanted: 8 in the patients described above, 3 in Florida, and 1 in Connecticut. Close clinical evaluation of the Connecticut and Florida patients has revealed no signs of infection. However, on November 15, an ophthamoligist in California noted P. aeruginosa endophthalmitis in a patient who had had implantation of a Copeland lens from a different lot.

The manufacturer has voluntarily recalled all lenses released after November 5, 1976, and reports that lenses released before that date have already been implanted. Reported by H Bauer, BS, L Ozols, BS, and B Poley, MD, AbbottNorthwestern Hospital, Minneapolis; D Gerding, MD, Minneapolis Veterans Administration Hospital; JS Andrews Jr, MD, Acting State Epidemiologist, and J Washburn, Minnesota State Dept of Health; G Stambaugh, MD, West Palm Beach, Florida; EWP Smith, MD, Acting State Epidemiologist, Health Program Office, Florida State Dept of Health and Rehabilitative Services; CF Chambers, MD, Ridgefield, Connecticut; JN Lewis, MD, State Epidemiologist, Connecticut State Dept of Health; J Chin, MD, State Epidemiologist, California State Dept of Health; U.S. Food and Drug Administration; and Bacterial Diseases Div, Bur of Epidemiology, CDC.

Editorial Note: This incident represents the second outbreak of endophthalmitis associated with implantation of lenses reported to CDC. The first outbreak, involving 11 cases of ocular infection with Paecilomyces lilacinus associated with lenses from a different manufacturer, occurred in late 1975. While some lens prostheses are sterilized by ethylene oxide, each of these reported outbreaks was associated with implantation of lenses disinfected with sodium hydroxide.

Reference

1. MMWR 24(52):437, 1975