Over-the-counter decorative contact lenses: Cosmetic or Medical Devices? A Case Series.
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.
Steinemann
Thomas L
TL
Divisions of Ophthalmology, MetroHealth Medical Center, Cleveland, OH 44109, USA. tsteinemann@metrohealth.org
Fletcher
Melissa
M
Bonny
Andrea E
AE
Harvey
Raymond A
RA
Hamlin
David
D
Zloty
Peter
P
Besson
Mike
M
Walter
Keith
K
Gagnon
Mike
M
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
D003358:Cosmetics