FDA warning on certain eye drops and saline (updated 2/1/24)

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|

Eye Drops Recalled – Read the full list here

A number of eye drops and saline have been recalled due to unsanitary manufacturing conditions.  Please review the product listings and links below. If you have these drops stop using them immediately.   January 31, 2024 - FDA  warning regarding copycat redness relief drops: https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-warns-consumers-over-copycats-bausch-lomb-eye-drops-2024-01-31/   January 2024: Addipak 5ml Lot: 3BO85 was recalled. FOR IMMEDIATE RELEASE –November 13, 2023– Mumbai, Maharashtra, Kilitch Healthcare India Limited is voluntarily recalling the eye drops products listed in the table below to the consumer level with all lots within expiry with expiration dates ranging from November 2023 to September 2025 for all the below-mentioned products. These products are being recalled due to potential safety concerns after FDA investigators found insanitary conditions. Read the full release here: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/kilitch-healthcare-india-limited-issues-voluntary-nationwide-recall-various-eye-drops-potential  Product Product Information NDC NO Retailer / Label LUBRICATING TEARS EYE DROPS 15 ML Dextran 70- 0.1% w/v, Glycerin 0.2% w/v, Hypromellose 0.3% w/v 0536-1282-94 Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops 15 ml Polyvinyl alcohol Eye Drops 1.4% w/v 0536-1325-94 Rugby High Performance Lubricant Eye Drops 15 ml (Single Pack) Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops 11673-522-15 Target High Performance Lubricant Eye Drops 15 ml (Twin Pack) Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops 11673-522-30 Target MULTI-ACTION RELIEF DROPS 15ML Polyvinyl alcohol 0.5% w/v, Povidone 0.6%w/v, Tetrahydrozoline 0.05% Eye Drops 11822-2254-3 Rite Aid LUBRICATING GEL DROPS 10ML Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops 11822-4540-3 Rite Aid LUBRICANT EYE DROPS 10ML (TWIN PACK) Propylene glycol Eye Drops 0.6% [...]

2024-02-01T10:36:14-05:00February 1, 2024|Clinic Updates, Blog Posts, SCLERAL, PROSE|

BostonSight Partners with Moorfields Eye Hospital to Bring BostonSight SCLERAL and Education to the UK

FOR IMMEDIATE RELEASE Contact: Michele Hart BostonSight mhart@bostonsight.org Needham, Mass. –October 17, 2023 – BostonSight®, a nonprofit healthcare organization that advances the treatment of diseased and damaged corneas and dry eye, announced today a licensing partnership with Moorfields Eye Hospital NHS Foundation Trust in the United Kingdom. “This partnership continues our commitment to ensure no one suffers loss of sight from corneal disease or irregularities and brings us one step closer to a world where everyone who needs a scleral lens can access one,” said Sara Yost, BostonSight’s President and CEO. “Patient care is the cornerstone of BostonSight’s mission. With Moorfields’ aligned focus on clinical care, scientific research, education, and medical device manufacturing, the partnership between our organizations makes a fantastic match.” Under the agreement, Moorfields will manufacture and distribute BostonSight SCLERAL® lenses in the UK through the NHS (National Health Service). BostonSight and Moorfields will also collaborate on educational initiatives, for both patients and doctors, to increase awareness of the benefits of scleral lenses and the conditions they treat. “Being able to produce these scleral lenses in-house will give our optometrists flexibility to effectively manage ocular surface disease and corneal ectasia, to provide comfort and relief to patients, and help improve their vision,” said Sarah Canning, head of optometry at Moorfields Eye Hospital. About BostonSight® BostonSight is a nonprofit healthcare organization that advances the treatment of diseased or damaged corneas and dry eye. Our ongoing commitment to research and achieving optimal patient outcomes through innovative scleral lens design, education, and [...]

2024-04-04T13:17:37-04:00October 17, 2023|Blog Posts, Press Release, SCLERAL|

Lora Castle Joins BostonSight as Director of Professional Affairs and Consultation

Will provide training, consultation, and fitting support to BostonSight SCLERAL customers and grow industry-wide scleral education. Needham, Mass. –May 16, 2023, BostonSight® announced today that Lora Castle, COA, NCLE, joins the organization as Director of Professional Affairs and Consultation for BostonSight SCLERAL. Ms. Castle brings 14 years of industry experience to BostonSight. BostonSight SCLERAL aims to provide the best scleral lens fitting experience and outcomes with a data-driven lens design, integrated FitConnect® design and ordering platform, and expert fitting support. With continued growth in customers, Ms. Castle will cultivate relationships with BostonSight SCLERAL customers and the industry through educational programs at meetings, conferences, workshops, and customer roundtables; onsite training visits; and exceptional customer service and fitting support. “Lora brings a wealth of fitting knowledge and will support BostonSight SCLERAL’s growing customer base to ensure success,” said Karen G. Carrasquillo, OD, PhD, FAAO, FSLS, FBCLA, BostonSight’s Senior VP of Clinical and Professional Affairs. “She will be dedicated to consultation, fitting support, and education that empowers practitioners and helps them meet the needs of all their patients. We’re thrilled to have her on board.” Ms. Castle previously served as Consultant, Vice President of Professional Services at Metro Optics, a manufacturer of custom contact lenses in the United States. Prior to that she worked as a program consultant in the Ophthalmic Assistant Program at Austin Community College where she taught and as a Supervisor and as a Certified Ophthalmic Assistant and Contact Lens Specialist at Eye Physicians of Austin, Texas. She has vast [...]

2024-04-03T12:41:07-04:00May 16, 2023|Blog Posts, Press Release, SCLERAL|

Successfully Managing Keratoconus with BostonSight SCLERAL

Sam went on a trip to Mexico for his honeymoon saw… a blurry tropical view. “I was so disappointed to be somewhere new and not able to see it,” he says. “Looking up at the night sky I’d see six moons instead of one.” Living with Keratoconus Sam has keratoconus. Keratoconus is a condition that affects at least 1 in 2,000 people in the U.S. It is a leading cause of corneal transplantation and a life-long disease that can cause blindness if left untreated. Keratoconus causes progressive thinning or distortion of the cornea, including a bulging cornea. This changes the corneal shape and significantly impacts vision. Symptoms can include higher order aberrations (HOAs) such as blurry vision, double vision, ghosted vision, and glare and halos around lights, as well as light sensitivity, corneal scarring, difficulty seeing at night, and eye irritation or headaches with eye pain. However, most cases of keratoconus can be successfully managed. Sam's Journey Sam’s keratoconus journey began when in seventh grade. He had already been wearing glasses since fourth grade, but his eye care provider noticed something unusual and sent him to a specialist, where he was diagnosed with keratoconus. He started wearing hard contacts to manage the condition. Later, a practitioner moved him into rigid gas permeable lenses, known as RGPs. Sam says that many keratoconus patients are started with RGPs. But RGPs were uncomfortable sitting on his distorted and thinned cornea, left significant ghosted images, and required a lot of care. “I always had [...]

2022-11-17T09:31:09-05:00November 17, 2022|SCLERAL, Blog Posts|

BostonSight Partners with Conoptica to Bring BostonSight SCLERAL Lenses and Education to Europe

Needham, Mass. –July 20, 2022 – BostonSight®, a nonprofit healthcare organization that advances the treatment of diseased or damaged corneas and dry eye announced today a licensing partnership with Conóptica of Spain. Conóptica is a subsidiary of Hecht Contactlinsen, a premier vision care company in Germany. Under the agreement, Conóptica will manufacture and distribute BostonSight SCLERAL lenses in Spain, Portugal, and  Morocco, and may expand to additional European markets in the future. “We’re excited to partner with Conóptica to bring BostonSight SCLERAL lenses to Europe,” said Sara Yost, BostonSight’s President and CEO.  “This partnership works toward our vision of ensuring that no one suffers loss of sight from corneal irregularities or corneal disease and brings us one step closer to making sure that everyone who needs a scleral lens, anywhere, can access one.” Conóptica has been providing gas-permeable lenses, eyecare equipment, and training to eye care practitioners in Spain and beyond since 1963. “We are committed to bringing the best scleral lens products, service, and education to our customers,” said Albert Noguera, President of Conóptica. “Adding BostonSight SCLERAL to our specialty lens offerings broadens our portfolio, thereby helping more people access the sight-saving benefits of scleral lenses. We are pleased to strengthen our relationship with BostonSight to educate practitioners so they may develop greater expertise in using scleral lenses to treat patients with dry eye, keratoconus, and other corneal issues.” About Conóptica Conoptica has more than 55 years of experience in the contact lens and optometry industry. The company provides products, [...]

2024-04-04T13:16:19-04:00July 19, 2022|Press Release, SCLERAL|

Dr. Bita Asghari, Associate Director of Clinical Education, Featured on Two Podcasts

Dr. Bita Asghari, PROSE provider and BostonSight's Associate Director of Clinical Education, was recently featured on two podcasts: Clique on Dry Eye: The Intersection of Scleral Lenses and Dry Eye Disease (19 min) Scleral contact lens expert, Dr. Bita Asghari, discusses how scleral contact lenses intersect with other dry eye therapies to bring patients maximal comfort.  Find out where sclerals can fit into your treatment strategy.   Try Not to Blink: Is it a Fit Issue or an Eye Issue In this special episode, Try Not to Blink hosts, Jimmy and Roya, talk to Dr. Asghari about her background and how she fulfilled her American Dream though her optometric career.

2024-04-04T13:36:35-04:00June 17, 2022|Blog Posts, In the Media, SCLERAL, PROSE|

BostonSight Announces Patient Marketing Campaign for BostonSight SCLERAL

Aims to inform patients of the benefits of scleral lenses for specific eye conditions    Needham, Mass. –April 19, 2022 –BostonSight announced today it has launched a patient marketing campaign for BostonSight SCLERAL®.  BostonSight SCLERAL is a commercially available scleral lens product manufactured by BostonSight. The intent of the campaign is to provide patients with easily accessible content about scleral lenses and to promote confidence that scleral lenses might be the right solution for their eye condition.   The campaign focuses on finding relief from three conditions for which scleral lenses are often used: dry eye disease, keratoconus, and post-LASIK ectasia. Current estimates put dry eye as affecting 1 in 100 adults and keratoconus at 1 in 2,000 people in the U.S., while post-LASIK ectasia is a rare but devastating side-effect of LASIK surgery. Each condition includes a profile of a patient with the condition, how the condition affected their life, their treatment path, and the outcome from using a scleral lens. When people can relate to a patient story, they can envision a positive outcome for themselves.  “Scleral lenses are becoming more and more common in the eye care industry, and they have enormous benefits,” said Karen G. Carrasquillo, OD, PhD, FAAO, FSLS, FBCLA, BostonSight’s VP of Clinical and Professional Affairs. “We want patients to know about the benefits of scleral lenses so they can find them earlier in their eye care journey. This campaign provides patients with the foundational tools to advocate for themselves and start a conversation with [...]

2024-04-04T12:18:14-04:00April 19, 2022|Press Release, SCLERAL|

How to Put in Eye Drops

Numerous eye health conditions require treatment with eye drops. Depending on your symptoms and diagnosis, various formulations may be recommended by your healthcare provider. Some eye drops are purchased over-the-counter whereas others require a prescription. While the use of eye drops to treat eye health problems might seem simple at first, many people find the use of eye drops more difficult in practice. Our BostonSight® PROSE patients are more than familiar with these challenges as most first-line treatments for eye conditions require the use of some type of eye drops. In fact, research has shown that even experienced eye drop users often are ineffective with their applications. To best treat your condition, it’s important to use your eye drops as directed by your physician. The National Institutes of Health provides a fact sheet with photos and offers these additional tips to use drops safely and correctly. Putting in eye drops – tips  Wash your hands before using eye drops, to prevent dirt or germs from getting into your eye. Tilt your head back and gently pull your lower eyelid down. Look up. Hold the bottle close to your eye, but do not let it touch your eye. Squeeze the eye drops into your lower eyelid, again without touching your eye. Let go of your eyelid and close your eyes (do not squeeze them shut). To prevent eye drops from leaking into your nose and throat, gently apply pressure to the inner corner of your eye. Use a clean, separate tissue to blot each eye if needed. Keep [...]

2022-10-12T14:32:57-04:00December 17, 2021|Blog Posts, SCLERAL, PROSE|

Dr. Karen Carrasquillo publishes case report in Contamac’s Global Insight

Dr. Karen Carrasquillo, OD, PhD, FAAO, FSLS, FBCLA, and VP of Professional and Clinical Affairs, published a case report in Contamac's Global Insight on September 30. Titled "Refitting Success: Reducing Suction and Maximizing Oxygen Permeability," Dr. Carrasquillo recounts the case of a 60-year-old woman with a history of keratoconus and dry eye syndrome in both eyes, history of corneal scraping in the left eye 25 years prior, history of post hydrops left eye, and questionable potential history of amblyopia left eye. Despite a good lens fit, the patient reported pressure sensation with device wear and difficulty with device removal at the end of the day. These symptoms are traditionally associated with lens compression and suction with increased wear time. Read the case report to see how Dr. Carrasquillo modified the lens design so that the patient was able to achieve 20/25+2 best corrected visual acuity with an average comfortable daily wear of up to 12 hours.

2024-04-03T12:32:17-04:00October 4, 2021|PROSE, In the Media, SCLERAL|
Go to Top