Eye Ointment Product Recall

Thane, Maharashtra, India, Brassica Pharma Pvt. Ltd. is voluntarily recalling Eye Ointment products listed in the table below with expiration date ranging from February 2024 to September 2025. The products are being recalled due to lack of sterility assurance at the facility noted during an inspection conducted by the Food and Drug Administration (FDA). Company Announcement Date: February 22, 2024 FDA Publish Date: February 26, 2024 Product Type: Drugs Reason for Announcement: Due to Potential Lack of Sterility Assurance. Company Name: Brassica Pharma Pvt. Ltd. Brand Name: Multiple brands Product Description: Eye ointment products Company Announcement FOR IMMEDIATE RELEASE – 12 February, 2024 – Thane, Maharashtra, India, Brassica Pharma Pvt. Ltd. is voluntarily recalling Eye Ointment products listed in the table below with expiration date ranging from February 2024 to September 2025. The products are being recalled due to lack of sterility assurance at the facility noted during an inspection conducted by the Food and Drug Administration (FDA). Risk Statement: For those patients who use these products, there is a potential risk of eye infections or related harm. These products are intended to be sterile. Ophthalmic drug products pose a potential heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses. To date, Brassica Pharma Pvt. Ltd. has not received any reports of adverse events up to 16th February 2024 related to this recall.   Product Name Package Description Brand Name NDC Lot# Exp Date Exp Date Equate Lubricant Eye Ointment [...]

2024-03-19T08:40:30-04:00March 6, 2024|Blog Posts, SCLERAL, PROSE|

Understanding Ocular GVHD: A Comprehensive Guide

*This article is a guideline only and not to be construed as medical advice. Always contact your eye care doctor with questions and for treatment options. Ocular Graft-versus-Host Disease (GVHD) is a complex condition that can significantly impact the eyes of individuals who have undergone hematopoietic stem cell transplantation. This comprehensive guide aims to provide valuable insights into ocular GVHD, covering its causes, symptoms, diagnosis, and management. What is Ocular GVHD?  Ocular GVHD is a manifestation of graft-versus-host disease, a common complication that arises after stem cell or bone marrow transplantation. In this condition, the donor's immune cells attack the recipient's tissues, leading to inflammation and damage in various organs, including the eyes. Causes and Risk Factors  Understanding the causes and risk factors of ocular GVHD is crucial for both patients and healthcare professionals. The primary trigger is the transplantation process itself, where the immune cells from the donor recognize the recipient's tissues as foreign and initiate an immune response. Other risk factors include the type of transplant, age, and the presence of pre-existing ocular conditions. Symptoms of Ocular GVHD  Recognizing the symptoms of ocular GVHD is vital for early intervention. Common symptoms include dry eyes, redness, light sensitivity, blurred vision, pain, and a gritty or burning sensation. Patients may also experience excessive tearing or mucous discharge. Diagnosis  Accurate diagnosis is essential for effective management. Ophthalmologists play a key role in diagnosing ocular GVHD by conducting a thorough eye examination, assessing symptoms, and utilizing advanced diagnostic tools such as tear [...]

2024-03-07T14:49:03-05:00March 5, 2024|Blog Posts, PROSE|

The Impact of Ocular GVHD on Quality of Life

*This article is a guideline only and not to be construed as medical advice. Always contact your eye care doctor with questions and for treatment options. Ocular Graft-versus-Host Disease (GVHD) is a complex and challenging condition that arises as a complication of allogeneic hematopoietic stem cell transplantation. This condition affects the eyes, leading to a range of symptoms that can significantly impact the quality of life of affected individuals. In this article, we delve into the intricate details of ocular GVHD and its profound implications on the well-being of patients. Understanding Ocular GVHD  Ocular GVHD occurs when donor immune cells recognize the recipient's tissues as foreign and mount an attack. This immune response targets the ocular surface, resulting in inflammation, damage to the cornea, and a host of ocular symptoms. Common symptoms include dry eyes, blurred vision, light sensitivity, and chronic eye discomfort. Quality of Life Impact  Persistent Discomfort: Ocular GVHD is often accompanied by persistent discomfort, ranging from a gritty sensation to a burning or stabbing pain. These symptoms can significantly reduce an individual's overall comfort and well-being, impacting daily activities and productivity. Visual Impairment: The condition can lead to visual impairment, making it challenging for patients to perform routine tasks such as reading, driving, or using digital devices. The resulting dependency on others for assistance can contribute to feelings of frustration and loss of independence. Emotional Toll: Coping with chronic ocular symptoms can take a toll on an individual's mental health. The emotional burden of dealing with a [...]

2024-03-07T14:48:51-05:00March 4, 2024|Blog Posts, PROSE|

Managing Ocular GVHD: Tips and Strategies for Patients 

*This article is a guideline only and not to be construed as medical advice. Always contact your eye care doctor with questions and for treatment options. Ocular Graft-versus-Host Disease (GVHD) is a challenging condition that affects the eyes of individuals who have undergone allogeneic hematopoietic stem cell transplantation. It occurs when transplanted immune cells recognize the recipient's tissues as foreign and attack them. Managing ocular GVHD requires a multifaceted approach to alleviate symptoms and improve overall eye health. In this article, we'll explore effective tips and strategies for patients grappling with this condition. Understanding Ocular GVHD  Before delving into management strategies, it's essential to comprehend the symptoms associated with ocular GVHD. Common signs include dry eyes, redness, light sensitivity, blurred vision, pain, and a gritty or burning sensation. The severity of these symptoms can vary, making personalized management crucial for each patient. Regular Eye Exams Routine eye examinations play a pivotal role in managing ocular GVHD. Patients should schedule regular appointments with their ophthalmologist to monitor any changes in their eye health. Early detection of complications can lead to more effective interventions, minimizing potential damage. Lubricating Eye Drops One of the primary complaints in ocular GVHD patients is dry eyes. Lubricating eye drops, artificial tears, and gels can provide relief by moisturizing the eyes and alleviating discomfort. Patients should use preservative-free formulations to prevent irritation. Prescription Medications For more severe cases, ophthalmologists may prescribe medications such as cyclosporine eye drops or corticosteroids to manage inflammation and immune responses. These medications [...]

2024-03-07T14:48:41-05:00March 3, 2024|Blog Posts, PROSE|

Navigating Ocular GVHD in Pediatric Patients: Overcoming Challenges and Essential Considerations

*This article is a guideline only and not to be construed as medical advice. Always contact your eye care doctor with questions and for treatment options. Ocular Graft-versus-Host Disease (GVHD) poses unique challenges when it affects pediatric patients. This condition arises as a complication of allogeneic hematopoietic stem cell transplantation, where the donor's immune cells attack the recipient's tissues, including the eyes. Managing ocular GVHD in children requires a specialized approach due to their distinct needs and considerations. In this blog post, we'll explore the challenges associated with ocular GVHD in pediatric patients and discuss crucial considerations for effective management. Understanding Ocular GVHD Ocular GVHD manifests as a chronic, immune-mediated disorder affecting the ocular surface. In pediatric cases, it presents an added layer of complexity, as children may have difficulty expressing their symptoms, making early diagnosis and intervention challenging. Challenges in Pediatric Cases  Communication Barriers: Children may struggle to articulate their symptoms or discomfort, making it crucial for healthcare providers to adopt a comprehensive approach that involves parents, caregivers, and age-appropriate communication techniques. Symptom Recognition: Ocular GVHD symptoms can overlap with other eye conditions, complicating diagnosis. Redness, dryness, light sensitivity, and blurred vision may be attributed to various factors, necessitating a keen eye for subtle signs. Treatment Compliance: Pediatric patients may find it challenging to adhere to complex treatment regimens. Balancing the efficacy of therapies with their impact on a child's daily life is vital for long-term success. Considerations for Pediatric Ocular GVHD Management Multidisciplinary Approach: Collaboration between pediatricians, ophthalmologists, [...]

2024-04-03T12:41:50-04:00March 2, 2024|Blog Posts, PROSE|

Ocular GVHD Symptoms and Warning Signs: What to Look For

*This article is a guideline only and not to be construed as medical advice. Always contact your eye care doctor with questions and for treatment options. Ocular Graft-versus-Host Disease (GVHD) is a serious condition that can affect individuals who have undergone allogeneic hematopoietic stem cell transplantation. While the disease primarily targets the eyes, its symptoms can often go unnoticed in the early stages. In this blog post, we'll delve into the crucial information you need to recognize the warning signs of ocular GVHD and seek timely medical intervention. Understanding Ocular GVHD  Ocular GVHD occurs when transplanted immune cells attack the recipient's eye tissues, leading to inflammation and damage. Recognizing the symptoms early on is vital for effective management and prevention of complications. Symptoms and Warning Signs of Ocular GVHD  Dry Eyes: Ocular GVHD often manifests as severe dry eyes, causing discomfort and blurred vision. Redness, Irritation, and Eye Pain: Persistent redness, irritation, and pain may be potential indicators of ocular GVHD. Light Sensitivity: Increased sensitivity to light can be an overlooked symptom of ocular GVHD. Blurred Vision: If you notice sudden or gradual blurred vision, it's crucial to consider ocular GVHD as a possible cause. Treatment and Management  Regular Eye Exams: Routine eye exams are essential for early detection; make them a priority, especially if you're at risk. Seek advice from ophthalmologists experienced in managing ocular GVHD for a comprehensive evaluation. Immunosuppressive Therapy: Understand how immunosuppressive medications can help control the immune response and minimize eye damage. Lifestyle Modifications: Lifestyle [...]

2024-03-07T14:48:20-05:00March 1, 2024|Blog Posts, PROSE|

PROSE Treatment Success Rates

In 2024, we surveyed 2,000 PROSE patients with ocular surface disease. The survey respondents reported high success rates, however, 62% of respondents reported they waited 3 or more years for a PROSE referral. Given the high success rate of PROSE, we hope to improve awareness of PROSE treatment earlier in individuals’ eye care journeys, both for patients and their referring specialists. Results Percent of survey respondents who reported that their eye health and vision improved after getting PROSE: Overall = 95% Dry eye = 87% Keratoconus = 98% Corneal transplant/scarring = 93% Exposure = 77% Ocular GVHD = 97% Sjögren’s: = 100% SJS/TENS = 100% Post-LASIK = 100% Percent of survey respondents who reported that their quality of life improved after getting PROSE: Overall = 96% Dry eye = 87% Keratoconus = 98% Corneal transplant/scarring = 95% Exposure = 92% Ocular GVHD = 97% Sjögren’s: = 100% SJS/TENS = 100% Post-LASIK = 100%

2024-04-04T13:54:58-04:00February 16, 2024|Blog Posts, PROSE|

Corneal Cross Linking: A Breakthrough Treatment for Keratoconus

This article is a guideline and should not be construed as medical advice. Always contact your eye care doctor with questions and for treatment options. In recent years, the field of ophthalmology has witnessed remarkable advancements in the treatment of various eye conditions, and one such breakthrough is Corneal Cross-Linking (CXL) for keratoconus. This innovative procedure has proven to be a game-changer, offering hope to individuals suffering from this progressive eye disorder. In this article, we will explore the intricacies of Corneal Cross-Linking, its benefits, and why it has become a widely acclaimed treatment for Keratoconus. Understanding Keratoconus Keratoconus is a corneal disorder characterized by the thinning and bulging of the cornea, leading to distorted vision. This condition often manifests during adolescence or early adulthood and can progress over time, causing significant visual impairment. Traditionally, treatment options were limited, and individuals with keratoconus faced the possibility of corneal transplantation. However, the advent of Corneal Cross-Linking has revolutionized the approach to managing this condition. What is Corneal Cross-Linking? Corneal Cross-Linking is a minimally invasive, outpatient procedure designed to strengthen the cornea and halt the progression of keratoconus. The procedure involves the application of riboflavin (Vitamin B2) eye drops to the cornea, followed by exposure to ultraviolet (UV) light. This combination induces a chemical reaction that strengthens the collagen fibers in the cornea, enhancing its structural integrity. Benefits of Corneal Cross-Linking  Halt Progression: One of the primary benefits of Corneal Cross-Linking is its ability to halt the progression of keratoconus. By strengthening [...]

2024-04-04T13:28:11-04:00February 15, 2024|PROSE|

How to Choose the Best Keratoconus Scleral Lens Specialist for Your Needs 

This article is a guideline only and is not to be construed as medical advice. Always contact your eye care doctor with questions and for treatment options. Living with keratoconus can be challenging, but the right scleral lens specialist can make a significant difference in your vision and overall quality of life. Choosing a keratoconus scleral lens specialist requires careful consideration and research. In this guide, we'll explore the key factors to consider when making this crucial decision to ensure you receive the best care tailored to your unique needs. Credentials and Expertise Start by researching the credentials and expertise of potential scleral lens specialists. Look for professionals who have specific training and experience in fitting scleral lenses for keratoconus patients. Board certification and memberships in relevant professional organizations are indicators of a specialist's commitment to staying updated on the latest advancements in the field. Patient Reviews and Testimonials Word of mouth is a powerful tool, especially in healthcare. Search for patient reviews and testimonials about different scleral lens specialists. Platforms like Healthgrades, Yelp, or Google reviews can provide insights into the experiences of other keratoconus patients. Pay attention to reviews that highlight the specialist's ability to address individual needs and provide personalized care. Technology and Equipment Opt for a scleral lens specialist who employs the latest technology and equipment. Advanced diagnostic tools can contribute to a more accurate fitting process, ensuring that your scleral lenses are custom-tailored for optimal comfort and vision correction. Inquire about the technology used during [...]

2024-04-04T13:46:24-04:00February 15, 2024|PROSE|

What to Expect When Visiting a Scleral Lens Specialist

This article is a guideline only and is not to be construed as medical advice. Always contact your eye care doctor with questions and for treatment options. Living with keratoconus can be challenging, but advancements in eye care have brought forth effective solutions, one of which is the use of scleral lenses. If you've recently been diagnosed with keratoconus or are considering scleral lenses as a treatment option, visiting a specialist is an important step in your journey to better vision. In this article, we'll explore what you can expect when visiting a keratoconus scleral lens specialist. Understanding Keratoconus  Before delving into the specialist visit, it's important to understand what keratoconus is. Keratoconus is a progressive eye condition in which the cornea thins and bulges into a cone-like shape. This distortion can cause visual impairment, making it challenging to see clearly. Scleral lenses are specially designed lenses that vault over the entire corneal surface, providing a more stable and comfortable vision correction option for individuals with keratoconus. Think of the scleral lens as a “new” cornea, which creates the shape of a typical cornea and allows light to enter the eye at the correct angle for good vision. The Specialist's Expertise A keratoconus scleral lens specialist is an optometrist or ophthalmologist with expertise in fitting and managing scleral lenses. During your visit, the specialist will conduct a comprehensive eye examination to assess the severity of your keratoconus and determine if scleral lenses are the right fit for you. Customized Fitting [...]

2024-04-04T14:11:02-04:00February 15, 2024|PROSE|
Go to Top