[11/3/2023] Cardinal Health Inc. has initiated a voluntarily recall for all lots of six Leader brand ophthalmic products. The list FDA provided on October 27 included five products branded as Leader. The list has been updated to include the sixth product.
Additionally, Harvard Drug Group LLC also initiated a voluntary nationwide recall for all lots of two Rugby Laboratories brand eye drops. The agency has updated the list of products to include the national drug codes (NDCs) that have been confirmed. FDA will provide additional information as it becomes available. [10/30/2023] FDA is updating the list of over-the-counter eye drop products consumers should not purchase or use to include Equate Hydration PF Lubricant Eye Drop 10 mL sold by Walmart in stores and online. Walmart is removing the product from their store shelves and website. [10/27/2023] FDA is warning consumers not to purchase and to immediately stop using 26 over-the-counter eye drop products due to the potential risk of eye infections that could result in partial vision loss or blindness. Patients who have signs or symptoms of an eye infection after using these products should talk to their health care provider or seek medical care immediately. These products are marketed under the following brands:
FDA recommended the manufacturer of these products recall all lots on October 25, 2023, after agency investigators found insanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility. FDA also recommends consumers properly discard these products. CVS, Rite Aid and Target are removing the products from their store shelves and websites. Products branded as Leader, Rugby and Velocity may still be available to purchase in stores and online and should not be purchased. FDA has not received any adverse event reports of eye infection associated with these products at this time. FDA encourages health care professionals and patients to report adverse events or quality problems with any medicine to FDA’s MedWatch Adverse Event Reporting program. Please click the link below for the full article. www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-certain-eye-drops-several-major-brands-due-risk-eye#eyedrops
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From the AOA:
The New York Times (2/2, Holpuch) reports Global Pharma, “the manufacturer of a brand of over-the-counter eye drops said that it was recalling the product, EzriCare Artificial Tears, after it was linked to a drug-resistant bacteria strain that has caused at least one person’s death and vision loss in five others.” The CDC “has advised people to stop using the eye drops, as the agency investigates an outbreak of a strain of the bacteria pseudomonas aeruginosa,” which “had never been identified in the United States before the current outbreak and is resistant to a class of antibiotics called carbapenems.” The Washington Post (2/2, Ables) reports the CDC’s warning comes “after 55 patients in 12 states were identified with infections caused by a strain...between May and January.” The AP (2/2, Stobbe) reports, “EzriCare, the company that markets the eye drops in the U.S., said it is not aware of any evidence definitively linking the outbreak to the product, but that it has stopped distributing the eye drops.” Ousley Vision Center is a healthcare facility and we take the safety of our patients and staff seriously. In our office, many safeguards are in place on an ongoing basis for the protection of our patients and staff. We ask that you make wise decisions and take proper precautions for your personal health and safety when entering our office.
Please let our staff know if you are more comfortable working with a mask on and we are more than happy to accommodate you during your visit. Upon entering our facility we are still requesting that all patients use hand sanitizer or wash their hands before proceeding with their exam or optical needs. Thank you! Due to the rise in local COVID-19 cases, we are asking ALL patients to wear a mask, even if you have been fully vaccinated.
Ousley Vision Center takes the health and safety of our patients and staff very seriously. We have many safeguards in place for everyone's protection. Thank you for your participation! Recent CDC updates state: fully vaccinated people can resume activities without wearing a mask with some exceptions.
Ousley Vision Center is a healthcare facility and we take the safety of our patients and staff seriously. In our office, many safeguards are in place on an ongoing basis for the protection of our patients and staff. We ask that you make wise decision and take proper precautions for your personal health and safety when entering our office. Please let our staff know if you are more comfortable working with a mask on and we are more than happy to accommodate you during your visit. Thank you! As of March 3rd, 2021, Gov. Abbott has lifted the mask mandate in the state of Texas. At this time, in consideration of our patients and staff, we will continue to require masks while in our office.
Thank you! Want to pick up your contacts/glasses/prescriptions curbside? We now have two spots reserved for you! Just call us when you arrive and let us know which spot you're in!
972-317-3937 We are still open and seeing patients! We have adjusted our hours to 8:30 a.m. - 5:00 p.m., (or by appointment) until further notice. If you are unsure we will be here, please call our office to ensure we will be here when you arrive.
We have missed our patients and are now scheduling regular, non-urgent and non-critical care exams.
In order to maximize your safety and minimize your risk of exposure to COVID-19, we have made changes in our office and with our procedure
Please follow our Instagram and Facebook pages for updates, specials, medical information and new styles in eyewear. The world has changed since your last visit with us, but one thing remains constant: our commitment to your health and well-being. We look forward to seeing you soon! Thank you for supporting our locally owned and operated business. Your Ousley Vision Team Due to the recently announced Denton County mandatory business COVID-19 restrictions, we are closing our practice until April 2, 2020.The health and well-being of our patients and staff are always our top priority. We are closely following the latest guidelines and restrictions to do our part in the promotion of the safety of our community.
We take our role seriously as front-line ocular healthcare providers, especially during this time when our services may actually keep someone out of the Emergency Room or Urgent Care (so those healthcare providers can focus on the priority of responding to COVID-19 testing and cases). We are open to seeing emergency or urgent patients on a case-by-case basis. If you feel you have an urgent concern regarding the health of your eyes, please call our office at 972-317-3937. We are checking our voicemail hourly. A doctor will return your call to assess your need and will meet you at the office if deemed necessary. In the mean time, if you have a question or need an appointment, please call and leave a message. We will still be checking our voicemail messages and will return your call when we re-open on April 2nd . And, of course, we will let you know as soon as we open our doors again. If you have any glasses or contact orders you have placed and wish to pick up we are offering curbside service on Thursday (3/26) and Friday (3/27) only. We hope to "see" you all soon and we will keep you updated on any changes. |
Stay tuned!Here we will post updates so you always know what's going on with the practice! Archives
November 2023
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