title: Over-the-counter decorative contact lenses: Cosmetic or Medical Devices? A Case Series.
abstract: OBJECTIVE
  To illustrate the implications of the unauthorized sale and unmonitored wearing of decorative cosmetic contact lenses resulting in ocular complications and to determine the prevalence of the use of cosmetic contact lenses obtained from unlicensed providers by adolescents.
  
  
  METHODS
  Observational case report, structured interview, and survey in a retrospective, observational, clinical practice setting. Reported sources of contact lenses were categorized as provider and nonprovider, and associations within the data were reviewed by using a Pearson correlation and chi-square test.
  
  
  RESULTS
  Twelve patients (eight female and four male) were seen urgently for acute eye pain and redness after wearing plano decorative contact lenses. None of the patients had previously worn a contact lens. None of the lenses were dispensed by eye care professionals. Four patients developed blinding infections requiring hospital admission. Causative organisms included staphylococci, Pseudomonas, and acanthamoeba. One patient required a penetrating keratoplasty. One hundred fifty-nine patients were surveyed. Thirty-seven (23%) used decorative contact lenses. Lenses were obtained from an unlicensed provider 51% of the time. Education about lens care and handling was significantly associated with acquiring lenses from licensed providers (R = 0.74, P < 0.0001).
  
  
  CONCLUSIONS
  Colored noncorrective contact lenses are being dispensed without a prescription or fitting from unlicensed vendors. Patients who acquire lenses from unauthorized providers are significantly less likely to be instructed on appropriate lens use and care. Consequently, uninformed lens wearers are experiencing acute vision-threatening infections and inflammation.
authors.affiliation: Divisions of Ophthalmology, MetroHealth Medical Center, Cleveland, OH 44109, USA. tsteinemann@metrohealth.org
authors.forename: Thomas L
authors.initials: TL
authors.lastname: Steinemann
authors.forename: Melissa
authors.initials: M
authors.lastname: Fletcher
authors.forename: Andrea E
authors.initials: AE
authors.lastname: Bonny
authors.forename: Raymond A
authors.initials: RA
authors.lastname: Harvey
authors.forename: David
authors.initials: D
authors.lastname: Hamlin
authors.forename: Peter
authors.initials: P
authors.lastname: Zloty
authors.forename: Mike
authors.initials: M
authors.lastname: Besson
authors.forename: Keith
authors.initials: K
authors.lastname: Walter
authors.forename: Mike
authors.initials: M
authors.lastname: Gagnon
mesh_terms: D000293:Adolescent; D000328:Adult; D001766:Blindness / Q000209:etiology; D003261:Contact Lenses / Q000009:adverse effects*; D003316:Corneal Diseases / Q000209:etiology*; D003358:Cosmetics / Q000009:adverse effects*; D018795:Device Approval / Q000331:legislation & jurisprudence; D004869:Equipment Safety; D015818:Eye Infections, Bacterial / Q000209:etiology*; D005260:Female; D006801:Humans; D008297:Male; D017755:Prosthesis Fitting; D012189:Retrospective Studies
chemical_list: D003358:Cosmetics