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This article was originally published in The Gray Sheet

Executive Summary

CIBA VISION MIRAFLOW CONTACT LENS CLEANER DISINFECTION CLAIMS "exceed the approved indication for use and misbrand the device," FDA tells the firm in a Jan. 21 warning letter. Approved via a premarket approval application to clean -- not disinfect -- soft and hard contact lenses, MiraFlow Extra Strength Daily Cleaner is being touted by Ciba Vision as a disinfectant in promotional letters and other materials, the agency says. FDA specifically cites a letter sent by the firm to eye care professionals in which Ciba Vision writes: "As you can see, the antimicrobial power of MiraFlow has been well documented over the past years," and data show "how favorably MiraFlow compares with various disinfectants, cleaners, and [rigid gas permeable contact lens] solution against Acanthamoeba, a dangerous pathogen against which effective treatment is difficult." The statements refer to studies contained in two journal articles that Ciba Vision included with its "Dear Doctor" mailing. FDA notes that the studies "do not duplicate actual use conditions for the product as described in the package insert, which is the application of one or two drops of the solution to lenses in hand." The agency underscores in the warning letter that an approved PMA, not journal studies, are necessary to support a claim for disinfection. FDA also cites Ciba Vision for making false or misleading comparative statements, including "unsubstantiated claims of superiority." Certain promotional materials, for instance, declare that "MiraFlow offers cleaning efficacy and antimicrobial power that is superior to Opti-Free Daily Cleaner, Bausch & Lomb Sensitive Eyes Cleaner [and] ReNu Multi-Purpose Solution," according to FDA. The agency concludes the Jan. 21 letter with a warning that "continued distribution of this device may result in...regulatory action without further notice." Ciba Vision said Feb. 5 that it currently is formulating a response to the warning letter. Another warning letter to Ciba Vision, sent by FDA's Atlanta district office on Dec. 17, 1992, cites the firm for not establishing an adequate complaint handling system. The December letter was based on an inspection of Ciba Vision's Atlanta facilities on Oct. 7-22, 1992. "A review of a representative sampling of your complaints received since January 1992 revealed at least 15 instances when your firm neglected to conduct complaint failure investigations on products which failed to meet release specifications." The contact lens product problems included thick edges, surface damage, edge defects and glass fragments in the vial. Ciba Vision's quality assurance procedures require a failure investigation when returned lenses do not meet release specifications, FDA points out. Complaint investigations that were conducted were "not always performed in a timely manner," the agency tells Ciba Vision. For example, "instances were noted where samples associated with [medical device reporting] complaints were not analyzed until five to six months after submission to the Quality Engineering Branch." FDA also says that Ciba Vision did not submit an MDR malfunction report after receiving information in a complaint "which reasonably suggested that one of your marketed devices had malfunctioned and could cause or contribute to a serious injury if the malfunction recurred." The agency requests a written MDR report for the incident as well as "all other reportable events received by your firm within the two-year period prior to the date of this letter which have not been reported to FDA." In a response to the Dec. 17 letter, Ciba Vision said that it addressed actions taken or to be taken based on a Jan. 4 "clarification" meeting with FDA at the company's Atlanta headquarters. Actions taken, Ciba says, included "strengthening of existing complaint handling and MDR procedures" such as the firm's standard operating procedures for handling verbal or written complaints from non-eye care professionals. Ciba maintains that its response satisfactorily addresses the issues raised in the warning letter. In another recent warning letter, FDA asks Anaheim, California-based Medtronic Blood Systems to submit a 510(k) for a heparin coating that it has been using with its Bio-Pump centrifugal pump. In the Jan. 22 communication, the agency comments that the addition of the material, known as the Carmeda (CBAS) heparin- based coating, is a "significant change" to the Bio- Pump that requires premarket notification.

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