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2016 Agenda and Abstracts | < Previous | Next > 2016 OMIG Abstract 5 Epidemiological Analysis of Non-Fusarium Contact Lens-Related Microbial Keratitis During the Worldwide ReNu-Related Fusarium Keratitis Event of Background: The manufacturer of the ReNu with MoistureLoc (RML) contact lens solution was cited by the U.S. Food and Drug Administration for inadequate temperature control of its products, with possible exposures up to 75oC (Eye & Contact Lens. 2016;42:147-152). RML failed to inhibit growth of Fusarium organisms after being heated in its plastic bottle to 56oC for 7 days (Arch Ophthal. 2011; 129:133-136). Failure of heated RML solutions to inhibit various bacterial and non-Fusarium fungal agents of keratitis was also noted experimentally (Eye & Contact Lens. 2012;38:222-226). With heating, RML’s antimicrobial agent, alexidine, was shown to absorb into its plastic bottle (N Eng J Med. 2014;370:88-89). Purpose: To determine whether there was an increased incidence of contact lens-related (CLR) bacterial and/or non-Fusarium fungal keratitis during the time period that RML was on the market. Methods: Data concerning CLR bacterial keratitis from the Wills Eye Hospital (Cornea. 2012;31:1097-1102) and CLR non-Fusarium fungal keratitis from a multi-center study (Ophthalmology. 2011;118: 920-926 [Table 3]) were obtained and analyzed using Poisson regression analysis (Cornea. 2008; 27:1013-1017). Results: Highly statistically significant increases in bacterial (P = 5.4x10-16) and non-Fusarium fungal Conclusions: These data strongly suggest that the antimicrobial failure of RML was not limited exclusively to Fusarium organisms but was also noted with a variety of bacterial and non-Fusarium fungal agents of keratitis, resulting in highly statistically significant increases in these CLR infections during the time period that RML was on the market. N 2016
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