Contact Lens Care & Compliance
Recommendations from the 2014 Ophthalmic Devices Panel
BY SUSAN J. GROMACKI, OD, MS, FAAO
On May 13, 2014, the United States Food and Drug Administration (FDA) convened an Ophthalmic Devices Panel of the Medical Devices Advisory Committee meeting. At the meeting, the FDA discussed proposed changes to the Contact Lens and Care Product Guidance Documents and acquired input from the panel of optometrists, ophthalmologists, scientists, and consumer and industry representatives.
The well-documented outbreaks of contact lens-related keratitis and the subsequent, permanent recall of two multipurpose contact lens care solutions (both of which had passed the FDA’s recommended testing) occurred more than seven years ago. In fact, despite new lens materials and care solutions, the FDA has not yet updated the May 1997 Premarket Notification (510(k)) Guidance Document for Contact Lens Products or the May 1994 Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses—composed 17 and 20 years ago, respectively.
The FDA began the meeting with a series of presentations outlining its own research and its latest understanding of several contact lens and care product topics. Next, FDA representatives fielded panel questions; the public was allowed to attend the meeting, but could not ask any questions. Then, the panel was allotted time to deliberate. In the afternoon, the FDA allowed a pre-approved public member from the Contact Lens Institute to give a presentation. This was followed by more questions from the panel to the FDA representatives. Finally, the FDA presented questions to the panel on the presentation topics.
Points of Discussion
The panel covered the following topics. Note: These are talking points, not suggested changes.
1. A New Grouping Scheme for Silicone Hydrogel Lenses The FDA recently added a Group 5 for silicone hydrogel lenses and proposes subdivisions within this group based on water content, ionicity, and lens surface.
2. A New Clinical Test Matrix for Contact Lens Care Products with Silicone Hydrogel Lenses Current testing requires 20 lenses from Group 1, 20 from Group 4, and a total of 20 from a control group. Proposed testing includes 30 lenses from all five Group 5 subdivisions as well as 30 from Group 4 and 90 total controls.
3. New Care Solution Products Are to Be Screened for Lens Preservative Uptake in the Future In other words, the FDA will require a certain concentration of preservative to remain within the manufacturers’ specifications after the required soak time. Those not passing will be listed as incompatible lenses in solution labeling.
4. Testing Under “Real World” Conditions This includes adding soil, extending the soaking time, and measuring lens uptake.
5. The Use of Tap Water with GP Lenses Although the FDA contraindicates this practice on its website, 15 of 18 GP lens solutions still allow a tap water rinse as part of their labelled instructions.
Complete details of the meeting are available at www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OphthalmicDevicesPanel/UCM400198.pdf. CLS
Dr. Gromacki is a diplomate in the American Academy of Optometry’s Section on Cornea, Contact Lenses and Refractive Technologies and practices in Chevy Chase, Md.