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Unregulated Contact Lenses

Study shows hazardous contamination

By Greg Evans, OD
Caution should be taken when purchasing decorative contact lenses.

Did you know you can change your eye color to match your outfit, or don scary snake eyes to match that perfect Halloween costume? Such fashion statements are possible, as a number of companies sell decorative, non-corrective contact lenses online.

There are also online companies selling corrective lenses to consumers without a prescription which are considered counterfeit as they are illegal in the United States. The FDA categorizes contact lenses as prescription medical devices not to be sold over-the-counter without a prescription, and for good reasons.

A recent study published in the Journal of Forensic Sciences issued a warning when they examined over 300 decorative, non-corrective contact lenses obtained without a prescription. What they found was shocking:

  • 60% of the counterfeit lenses tested positive for microbial contamination;
  • 27% of the unapproved lenses tested positive for microbial contamination;
  • 3% of authentic contact lenses were positive for microbial contamination;
  • 48% of the non-prescribed brands tested had at least one nonsterile sample.

The organisms isolated were as follows: Pseudomonas, Stenotrophomonas, Bacillus altitudinis, Bacillus thuringiensis, Enterobacter species, Klebsiella pneumoniae, Pseudomona monteilii, Micrococcus luteus, Herbaspirillum, Rhodococcus baikonurensis, Pseudomonas fluorescens A, Delftia acidovorans, Pseudomonas veronii, Achromobacter denitrificans, Elizabethkingia species, Bacillus fusiformis, Bacillus cereus, Bacillus simplex, Ochrobactrum anthropi, Rhizobium species, Brevundimonas, Spingopyxis terrae, Aquabacterium species.

Of these, both Bacillus cereus and Pseudomonas aeruginosa pose considerable health risk for ocular tissues and a common cause of microbial keratitis and corneal ulcers.

FDA requires prescriptions for all contact lens products, and yet each year thousands of consumers obtain contact lenses through channels that evade regulatory authority. These contact lenses have been shown to have levels of microbial contamination up to 20 times higher than those obtained through normal channels. In addition, consumers who obtain these often do not have proper disinfection, proper monitoring, and proper instruction on usage.

The bottom line is patients that purchase counterfeit and unapproved contact lenses are putting themselves at risk of ocular infections including microbial keratitis, conjunctivitis and possible blindness.

Dr. Evans is the founding owner of Evans Eye Care in Palm Desert and can be reached at (760) 674.8806 or online at www.evanseyecare.com.

Source: 1) Land et al, J Forensic Sci, 2017 doi: 10.1111/1556-4029.13553 available online at: www.onlinelibrary.wiley.com

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