IMPORT ALERT #86-10, 4/1/03, "DETENTION WITHOUT PHYSICAL EXAMINATION OF
DECORATIVE CONTACT LENSES"


          TYPE OF
          ALERT:    Increased Coverage
               Detention without Physical Examination (DWPE)

               (Note: This import alert represents the Agency's current guidance
          to FDA field personnel regarding the manufacturer(s) and/or
          products(s) at issue.  It does not create or confer any rights for
          or on any person, and does not operate to bind FDA or the public).

          PRODUCT:  Decorative contact lenses that are (1) intended to change the
          appearance of the eye in decorative fashion and (2) intended for
          distribution directly to the wearer, without the involvement of a
          qualified eye care professional. The alert does not cover contact
          lenses that are intended for vision correction, prosthetic, or
          other medical use.

PRODUCT
CODE:          86H[][]PX
          86H[][]JK
          86H[][]QD
          86M[][]UW
          86M[][]VN
          86M[][]WL
          86N[][]CZ
          86N[][]IC
          86L[][]PL
          86L[][]PM

          PROBLEM:  FDA believes these products present substantial risks to ocular
          health, including corneal scarring and blindness, when dispensed
          without the involvement of a qualified eye care practitioner. In
          legal terms, they appear to be adulterated or misbranded under the
          Federal Food, Drug, and Cosmetic Act.

PAF:      HAZ   Hazardous Conditions
          AAP - Approvals

PAC FOR
COLLECTION:    82008

COUNTRY:  All (ZZ)

MANUFACTURER/
SHIPPER
FEI:      See Attachment

         CHARGE:    "The article is subject to refusal of admission pursuant to
         Section 801(a)(3) in that it appears to bear or contain a
         poisonous or deleterious substance which may render it injurious
         to users under the conditions prescribed in the labeling or under
         such conditions of use as are customary or usual. [Adulteration,
         Section 601(a)]."

                         or

               "The article is subject to refusal of admission pursuant to
          Section 801(a)(3) in that it is not a hair dye and appears to bear
          or contain a color additive which is unsafe within the meaning of
          Section 721(a). [Adulteration, Section 601(e)]."

                         or

               "The article is subject to refusal of admission pursuant to
          Section 801(a)(3) in that its labeling appears to be false or
          misleading within the meaning of Section 201(n). [MISBRANDING,
          Section 602(a)]."

OASIS CHARGE
CODE:          POISONOUS
          COSM COLOR
          COSM MISB

RECOMMENDING
OFFICE:   Office of the Chief Counsel (GCF-1)

REASON FOR
          ALERT:    This alert was initiated in response to information indicating a
          risk of permanent eye damage, including corneal infections
          resulting in scarring and (potentially) blindness, resulting from
          product use and particularly wear beyond the recommended period,
          lens sharing between individuals, improper fit.

          GUIDANCE: Review all entries of contact lenses to determine their PMA/510(k)
          status.  If a PMA/510(k) is not on file and the product is not
          listed on the Attachment, the product may be sampled and/or
          detained without physical examination as follows:

               *   If the product is labeled solely to change the appearance of
          the eye in decorative fashion, districts may sample and/or detain
          the shipment using the charges cited in this alert.  For guidance,
          contact James F. Saviola, O.D., F.A.A.O., CDRH, Office of Device
          Evaluation (HFZ-460) (FAX 301-480-4201).

               *   If the product is labeled for vision correction or prosthetic
          use, districts may detain the shipment using the appropriate
          charge as referenced in Import Alert# 89-08.

          Appropriate OASIS screening criteria has been set.

PRIORITIZATION
GUIDANCE: N/A

FOI:      No purging required

KEYWORDS: Decorative Contact Lenses, Noncorrective Contact Lenses, Cosmetic
          Contact Lenses, Novelty Contact Lenses, Plano Contact Lenses

PREPARED
BY:       Ted Poplawski, DIOP (301) 443-6553

DATE LOADED
INTO FIARS:    April 1, 2003                         ATTACHMENT FOR IMPORT ALERT# 89-10

Manufacturers/Shippers of Decorative Contact Lenses not recommended for DWPE

FIRM                               PRODUCT DESCRIPTION


At the time of publication in the Federal Register, there were no firms
identified.