At the beginning of 2013, Hoya Surgical Optics was in a strong position: it was the third largest manufacturer of intraocular lenses (IOLs) in the world and fastest-growing in the European and Asia-Pacific markets. But the good news came to a screeching halt in February when, as a result of surgeons reporting higher than usual rates of ocular inflammation following implantation, all Hoya one-piece IOLs were subject to voluntary recall.
Sales stopped immediately, as did manufacturing at Hoya’s Singapore facility. The company initiated a root-cause analysis, thoroughly reviewing all aspects of their manufacturing process, to identify the source of contamination and irritation. The IOL washing process involved placing the lenses on a Teflon-coated block of aluminum, and it seems that this caused small particles of aluminum to be transferred onto the IOL. Aluminum is known to have cytotoxic properties, and animal implantation studies confirmed that aluminum-contaminated IOLs can cause ocular inflammation. The corrective action was simple: replace the Teflon-coated aluminum washing racks with ceramic racks. It worked. Validation studies in rabbits confirmed that the IOLs no longer had eye-inflaming properties, and production was restarted. Hoya is certainly not the first IOL manufacturer to recall lenses, and unlikely to be the last. But can they bounce back? Back in the market for just over a month at the time of writing, it’s looking likely. Bruno Chermette, President of Hoya Surgical Optics for Europe, the Americas, and the Asia-Pacific regions, noted that Hoya was already selling at 70 percent of its pre-recall levels in Germany and 40 percent in France.
