EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.
Issue link: https://digital.eyeworld.org/i/276058
by Matt Young EyeWorld Contributing Writer HOYA comes clean in a refreshing way Bucking the ophthalmic trend, HOYA details exactly what went wrong with its IOLs and why W h en something goes wrong in the oph- thalmic manufactur- ing world, companies often don't have a reputation for directly addressing the problem and completely resolv- ing it, especially when this involves company culpability. W hen it comes to positive pub- lic relations, there's no singling out one industry company. Microker- atome blade lot numbers and DLK, femtosecond lasers and transient light sensitivity, blurred vision and IOLs— all have been issues that, at some point, sug- gested a company's manufacturing process may have been amiss. While ob- fuscation may continue, HOYA Surgical Optics has taken a decidedly different approach. Recall and response It all began February 20, 2013, with a short press release out of Singapore at the company's headquarters: "HOYA Surgical Optics announced a voluntary recall of NY-60, iSert 250, iSert 251, Toric 311, and iSert Toric 351 IOLs as additional action to an e arlier suspension of shipments due to reports of higher than expected rates of inflammation and/or endophthalmitis from doctors in a few countries. HOYA apologizes for any incon- venience this may cause." For a press release, this was short and not yet forthcoming. But then at the 2013 European Society of Cataract & Refractive Surgeons (ESCRS) Congress, HOYA did a number of fairly remarkable things. HOYA called a press conference to specifically address its manufacturing changes. The company invited reporters to inform them about the comeback to the market and to explain the improve- ments of the manufacturing process by one of the lead inves- tigators into the matter. All ques- tions were answered directly. Keep in EW International 144 March 2014 mind that this was a not a manda- tory meeting to address concerns by a regulatory body or provide forced responses due to probing questions by reporters. This was an event to s pecifically address manufacturing findings that had arisen in a room full of reporters called there by the company. A world-renowned investigator spoke on the investigation of the issue. Liliana Werner, MD, PhD, associate p rofessor and co-director, Inter- mountain Ocular Research Center, John A. Moran Eye Center, Univer- sity of Utah, Salt Lake City, was one of the lead investigators into the problem, demonstrating the serious extent to which HOYA was dedi- cated to determining a solution. Another investigator was Nick Mamalis, MD, one of the world's leading investigators of toxic ante- rior segment syndrome (TASS). "HOYA started seeing reports from surgeons of higher-than-antici- pated rates of inflammation after cataract surgery implantation of their lens," Dr. Werner said at the event. "It was interesting that the finding of the reports correlated to a change in the manufacturing process." The problem was attributed to the company's manufacturing process. After a thorough review of many possible causative factors, high mag- nification microscopy and surface analyses revealed the presence of aluminum particulates on the surface of some HOYA IOLs. "During one of the final stages of normal production of these lenses, the lenses are placed in a washing fixture," Dr. Werner said. "There was a precise correlation between the reported increase in inflammation and the transition to Teflon-coated aluminum washing fixtures. So there was a coincidence in timing there." It is believed that the Teflon coating was worn away, exposing the aluminum base of the washing fixture underneath and causing aluminum particulates to deposit on the IOL surfaces. T here is an old saying that still holds true—it is not the crime, it's the cover up. The corollary is that what matters most is not the complication, it's the recov- ery. This seems like such a simple concept but it is advice that is often ignored. In general, we have a great capacity for for- g iveness of mistakes but not for cheating. As a company, HOYA understands this and is to be commended for its transparency and dedication to making things right. It is a simple story with a straightforward moral: We all make mistakes. Admitting this takes broad shoulders but is always the right thing to do. John A. Vukich, MD, international editor International outlook 144-148 International_EW March 2014-dl2_Layout 1 3/6/14 4:18 PM Page 144