Contact Solution Maker Failed To Report Problems

Despite that violation and a half-dozen other documentation problems involving consumer complaints and quality control, the FDA never pursued legal action against AMO.

The FDA routinely issues warning letters to companies that don't follow regulations. The letters are not legally binding and the agency rarely takes companies to court over the violations. Even that step was not taken with AMO.

Instead, after the recall, the FDA met with the company and discussed the problems outlined by the inspectors' report, known as a Form 483.

"FDA felt that the company's response to the 483, in conjunction with the face-to-face meeting, were adequate," said agency spokesman Christopher Kelly.

The company agreed to comply with regulations and outlined plans for doing so, FDA said. The plant is subject to a follow-up inspection.

The Acanthamoeba is a microscopic organism typically found in water or soil that can cause devastating harm when it enters the eye, usually by attaching to a contact lens. It is notoriously difficult to kill because it can seal itself in a protective coating when confronted with antibacterial drugs, and emerge unharmed weeks or months later.