Volume 16, Number 9—September 2010
Letter
Contact Lens Solution–associated Acanthamoeba and Fusarium Keratitis
To the Editor: Verani et al. (1) detailed the 2004–2007 outbreak of Acanthamoeba keratitis (AK) in persons wearing soft contact lenses who used Complete MoisturePlus (CMP) multipurpose contact lens solution (Advanced Medical Optics, Santa Ana, CA, USA). They noted similarities between the AK outbreak and the Fusarium keratitis (FK) outbreak of 2004–2006, including the concomitant time frame and association with a particular solution, ReNu with MoistureLoc (Bausch & Lomb, Rochester, NY, USA). Both solutions were new products introduced within 1 year before the respective outbreaks.
In neither outbreak was the solution contaminated; in both outbreaks, implicated bottles were from multiple lots, suggesting that each outbreak resulted from insufficient antimicrobial activity. However, in the FK outbreak, all reported cases involved bottles produced at 1 (Greenville, SC, USA) of 4 multinational Bausch & Lomb manufacturing plants (2). After a Food and Drug Administration inspection of the Greenville facility, Bausch & Lomb was cited for inadequacies in temperature control during production, storage, and transport of its products in and beyond the plant (3).
We experimentally demonstrated that, when exposed to prolonged temperature elevation, ReNu with MoistureLoc loses more in vitro fungistatic activity than do other contact lens solutions. We concluded that improper temperature control of ReNu with MoistureLoc may have contributed to the FK outbreak (4). We are aware of no other theory that adequately explains why only ReNu with MoistureLoc from only 1 plant was implicated.
CMP was manufactured and used internationally; AK has a much higher incidence in Europe and Hong Kong than in the United States (5), and CMP–associated AK has been reported internationally (6). Therefore, it would seem critical to know, and we would like the authors to comment on, whether the geographic pattern of the AK coincided with distribution of CMP solution from >1 Advanced Medical Optics manufacturing plants and, if so, the relevance of that information.
References
- Verani JR, Lorick SA, Yoder JS, Beach MJ, Braden CR, Roberts JM, National outbreak of Acanthamoeba keratitis associated with use of a contact lens solution, United States. Emerg Infect Dis. 2009;15:1236–42. DOIPubMedGoogle Scholar
- Levy B, Heiler D, Norton S. Report on testing from an investigation of Fusarium keratitis in contact lens wearers. Eye Contact Lens. 2006;32:256–61. DOIPubMedGoogle Scholar
- US Food and Drug Administration. FDA Form-483 [cited 2007 Jul 28]. http://www.fda.gov/downloads/AboutFDA/CentersOffices/ORA/ORAElectronicReadingRoom/UCM059206.pdf
- Bullock JD, Warwar RE, Elder BL, Northern WI. Temperature instability of ReNu with MoistureLoc: a new theory to explain the worldwide Fusarium keratitis epidemic of 2004–2006. Arch Ophthalmol. 2008;126:1493–8. DOIPubMedGoogle Scholar
- Lam DS, Houang E, Fan DS, Lyon D, Seal D, Wong E, Incidence and risk factors for microbial keratitis in Hong Kong: comparison with Europe and North America. Eye (Lond). 2002;16:608–18. DOIPubMedGoogle Scholar
- Por YM, Mehta JS, Chua JL, Koh TH, Khor WB, Fong AC, Acanthamoeba keratitis associated with contact lens wear in Singapore. Am J Ophthalmol. 2009;148:7–12.e2.
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In Response: We thank Bullock and Warwar for offering their theory of potential consequences of manufacturing inadequacies in temperature control during production of ReNu with MoistureLoc (Bausch & Lomb, Rochester, NY, USA) associated with the Fusarium keratitis (FK) outbreak during 2004–2006 (1). They note the substantial similarities between the FK outbreak and the Ancanthamoeba keratitis (AK) outbreak that we reported (2). They inquire whether the geographic pattern of AK outbreak–associated cases coincides with distribution of >1 manufacturing plants for the associated product, Complete MoisturePlus (CMP) multipurpose contact lens solution (Advanced Medical Optics [AMO], Santa Ana, CA, USA).
We obtained lot numbers for 22 bottles of CMP that AK case-patients used before symptom onset. Because no lot number was repeated, intrinsic contamination was unlikely as the source of the AK outbreak; the geographic and temporal distribution of cases further argued against a point-source outbreak. All 17 lot numbers for which AMO plant of origin was determined were manufactured in Spain (Food and Drug Administration, pers. comm.). According to a press release from AMO in November 2006, the “vast majority of AMO's contact lens solution products distributed in the U.S.” were manufactured in the company’s production facility in Spain, 1 of its 2 international manufacturing plants (3).
CMP was produced and used internationally at the time of the US multistate outbreak (4). Por and colleagues (5) reported an increase in the number of AK cases among contact lens users in Singapore that temporally coincided with the US outbreak. However, their retrospective case series did not include a control group; therefore, measuring associations between particular contact lens products and AK was not possible for those case-patients. The authors reported that a case–control study was underway, and we look forward to seeing the results of that investigation to better understand the magnitude of AK cases associated with CMP use.
References
- Bullock JD, Warwar RE. Contact lens solution–associated Acanthamoeba and Fusarium keratitis [letter]. Emerg Infect Dis. 2010;16:1501–2. DOIPubMedGoogle Scholar
- Verani JR, Lorick SA, Yoder JS, Beach MJ, Braden CR, Roberts JM, National outbreak of Acanthamoeba keratitis associated with use of a contact lens solution, United States. Emerg Infect Dis. 2009;15:1236–42. DOIPubMedGoogle Scholar
- US Food and Drug Administration. Advanced Medical Optics announces voluntary recall of 18 lots of Complete(R) MoisturePLUS(TM) contact lens care products distributed and sold in the U.S. Includes certain lots of 12-ounce bottles and active packs [cited 2010 Jun 11]. http://www.fda.gov/Safety/Recalls/ArchiveRecalls/2006/ucm112073.htm
- US Food and Drug Administration. Advanced Medical Optics, Inc. COMPLETE® MoisturePLUS™ multi-purpose contact lens solution [2010 Jun 11]. http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm062478.htm
- Por YM, Mehta JS, Chua JL, Koh TH, Khor WB, Fong AC, Acanthamoeba keratitis associated with contact lens wear in Singapore. Am J Ophthalmol. 2009;148:7–12.e2.
Table of Contents – Volume 16, Number 9—September 2010
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