Association of Regulatory Boards of Optometry www.arbo.org

Ocular Health Complications occur when Contact Lenses are purchased without a valid Rx.

The CL Complications Form came about in response to a presentation by a representative of the state attorneys general during the 2002 ARBO Annual Meeting in New Orleans. He stated he was unaware of any complications due to purchasing CL’s without a prescription.

ARBO recognized a need and authorized an ongoing study to research contact lens complications related to lenses purchased without a valid prescription. Since January 2003, ARBO has collected 234 cases.

ARBO’s mission is to support State Boards efforts to protect the public.

Our first press conference was at the 2004 SECO International. All data has been submitted to the Senate HELP Committee, the FTC, the FDA, and the State Attorneys General.

The FDA’s response to some of ARBO’s and AOA’s earlier

findings

Decorative Contact Lenses http://www.fda.gov/cdrh/contactlenses/FDA Warning Letter issued to The One and Only Fashion Beauty Group October 26,

2004 (also available in PDF*) FDA Warns Consumers of the Dangers of Using Decorative Contact Lenses Without

Proper Professional Involvement October 28, 2004 FDA Warning Letter to Beauty Supply, dba Beauty World, Addresses Tinted Contact

Lenses May 10, 2004 (also available in PDF*) FDA Warns Consumers Not to Use Decorative Contact Lenses Without Proper

Professional Involvement October 10, 2003 FDA Warning Letter to BWild Incorporated September 16, 2003 (also available in

PDF) Federal Register Notice: Guidance to FDA Staff on Sampling or Detention Without

Physical Examination of Decorative Contact Lenses (Import Alert 86-10); Availability April 4, 2003

Import Alert 86-10: Detention Without Physical Examination of Decorative Contact Lenses April 1, 2003

COMPLICATION(S) DUE TO CONTACT LENSES DISPENSED WITHOUT A VALID PRESCRIPTION REPORTING FORM Tel: (314) 785-6000 • Fax: (866) 886-6164 • E-mail: arbo@arbo.org

Reference Letters and/or Numbers for Your Personal Use Only: (which does not identify the individual patient)

__Burning __Dry Eye

__Conjunctivitis __Foreign Body Sensation

__Corneal Distortion __Giant Papillary Conjunctivitis (GPC)

__Corneal Edema __Itching

__Corneal Epithelial Defect __Keratitis

__Corneal Infiltrate __Neovascularization/Pannus

__Corneal Opacity __Ocular Inflammation

__Corneal Ulcer __Pain

__Discharge __Stinging

__Other (please comment)

Treatment Plan: Outcome:

__Lubricants __Return to Pre-Incident Status

__Antibacterial Topical/Oral __Short Term Vision Loss

__Antibacterial/Anti-Inflammatory/ __Permanent Vision Loss

Topical/Oral

__Surgical Intervention __Penetrating Keratoplasty

__Other (please comment) __Other (please comment)

Financial Impact to Patient/Health Care Resources Utilized

Medical Costs (Out of Pocket) $_________________

Medical Costs (Third Party Payer) $_________________

Sick Days Lost $_________________

Loss of Income due to Office Visit, $_________________

Total or Partial Disability, etc.

Date: ____________ Doctor: ______________ Phone:___________

Current Reported Results (n=234)

CL Complication Signs and Symptoms:

Corneal edema (37%)

Stinging (36%)

Neovascularization or pannus (36%)

Pain (35%)

Burning (35%)

Foreign body sensation (32%)

Corneal epithelial defect (32%)

Conjunctivitis (29%)

Current Reported Results (n=234)

CL Complication Signs and Symptoms (continued):

Ocular inflammation (27%)

Corneal infiltrate (25%)

Corneal distortion (23%)

Keratitis (21%)

Corneal ulcer (20%)

Giant Papillary Conjunctivitis (GPC) (17%)

Dry eye (18%)

Itching (13%)

Current Reported Results (n=234)

CL Complication Signs and Symptoms (continued):

Discharge (12%)

Corneal opacity (12%)

Blurred vision (5%)

Iritis (1%)

The reported signs and symptoms that increased from the 2005 report were: conjunctivitis, corneal ulcer, and corneal opacity.

Current Reported Results (continued)

CL Complication Treatment Plans required :

Antibacterial/anti-inflammatory topical/oral meds (40%)

Lubricants (33%)

Antibacterial topical/oral meds (26%)

Refit correct contact lenses (9%)

Decrease/discontinue contact lens wear (5%)

Current Reported Results (continued)

CL Complication Outcomes:

Short-term vision loss (18%)

Returned to pre-incident status (18%)

Permanent vision loss (8%)

Permanent scarring (3%)

Penetrating keratoplasty (1%)

Since 2005, Permanent vision loss increased.

Current Reported Results (continued)

CL Complication’s cause financial impact:

Average Out of Pocket cost from patient $98.18

Average Third Party Payment for office visit's $158.33

Average Patient Loss of Income $108.92----------------------------------------------------------------------------------Total Cost per incidence $365.43

Since 2005 Total costs increased 34%

ARBO supports on going Public Protection

ARBO realizes the ongoing research has provided important information to entities involved in setting health care policy, rules, and regulations for patient eye health.

ARBO encourages the Federal Government to continue its effort to police and eliminate the ability to purchase a contact lens without a valid prescription.

ARBO requests your help!

• ARBO has taken the lead on this important discovery and requests all eye care professionals utilize the Contact Lens Complication Form every time they encounter patients who enter their offices with signs, symptoms, or complaints about a contact lens they purchased without a valid prescription.

The Political Landscape of contact lenses sold to the public without a verified

prescription

• The Fairness to Contact Lens Consumers Act took effect February 2, 2004. In July 2004, the FTC implemented the act.

• October 2005, the US Federal Trade Commission issued a formal warning to 1-800 Contacts, Inc. that cited “substantial number of complaints” arising from the company’s contact lens prescription verification practices.

• In order to protect the public safety, the “passive verification loophole” within FCLCA should be eliminated in any future legislation. A contact lens is a medical device and can cause ocular complications without proper verification.

• S 2480 limits consumer choice for contact lens purchasing to those lenses 1-800 can distribute. Similar state bills have been rejected in Florida, Georgia, Indiana, Louisiana, and West Virginia.

The Political Landscape of contact lenses sold to the public without a verified

prescription

• Washington – October 26, 2005 – The U.S. House of Representatives made final approval of a bill (S.172) to protect Americans from eye injuries due to the misuse of zero power “decorative” contact lenses.  Rep. John Boozman (R-AR) led the bi-partisan effort to pass S. 172 and close a 2 1/2 year old loophole that, in spite of warnings by the nation's eye care providers and Federal health officials, has allowed decorative contact lenses to be considered an unregulated cosmetic rather than a regulated medical device.  With mounting evidence of grievous harm resulting from the unsupervised use of decorative lenses provided to Congress by many eye health organizations, the U.S. Senate acted first and approved S. 172 in July with strong support from Senators Michael Enzi (R-WY), Mike DeWine (R-OH) and Edward Kennedy (D-MA). 

• President Bush signed the bill into law on November 9, 2005.

Thank you

• Thank you for supporting ARBO’s effort to inform the States Attorneys General, the FTC, the FDA, the Congress, and the Senate about CL Complications related to improper prescriptions. The Public Ocular Safety has been fortified!

• We have not finished, please continue to support ARBO’s effort in collecting contact lens complication data to help ensure public protection.