Through the Eye to the Spine

HOT TOPIC

New Recall for Eye Care Products Over Manufacturing Violations

A nationwide recall was recently issued for multiple OTC eye care products, including artificial tears and lubricant eye drops, due to serious manufacturing violations identified during an FDA audit. The recall, initiated by BRS Analytical Service and distributed by AvKARE of Pulaski, Tennessee, affects approximately 1.8 million cartons of five ophthalmic solutions shipped between May 26, 2023, and April 21, 2025.

The FDA audit revealed deviations from Current Good Manufacturing Practices, raising concerns about the products’ sterility and quality, which could pose significant health risks, including potential infections or, in extreme cases, vision loss. Consumers are urged to immediately stop using the affected products, which include various lot numbers detailed in the recall notice, and to report any adverse reactions to the FDA’s MedWatch program. Customers are also instructed to complete the “Quantity to Return” section of the recall notice and submit it via email to customerservice@avkare.com, even if they no longer possess the products. The exact health hazards remain unspecified, but the manufacturing issues suggest a risk of unacceptable product quality. This recall follows a pattern of recent eye care product recalls, including earlier cases linked to bacterial contamination, highlighting ongoing challenges in ensuring the safety of ophthalmic solutions. For a complete list of affected lot numbers and further details, consumers are directed to AvKARE’s recall notice.

My Two Cents

Another big eye drop recall. Interestingly, as I wrote this, I couldn’t figure out the precise reason for the recall. The only information present is “serious manufacturing violations.” Hopefully, this information will be shared with the eye care industry so that we can all learn from it. Not only that, but it would also help instill confidence and security in the public regarding what is available to them for help in combating dry eye and other ocular issues. Once again, this underscores my firm belief in not only strongly recommending certain drops to my patients, but also especially prescribing them from the chair! If you simply toss a sample of whatever is lying around at your patient without good reason, you are only helping to commoditize these products, which are so much more than that. For many patients, they are a perfectly good first-line treatment.

OUTSIDE THE LANE

Neurosurgeons Remove Spinal Tumor Through Eye Socket

In a groundbreaking procedure at the University of Maryland Medical Center (UMMC), neurosurgeons successfully removed a rare chordoma tumor from the spine of a 19-year-old patient using a novel transorbital approach through her eye socket, marking the first such surgery.

This case is significant for eye care professionals because the patient initially presented with double vision, which led to the diagnosis of the chordoma, a rare developmental bone tumor, which was wrapped around the patient’s spinal cord and vertebrae near the skull base, posing risks of paralysis or death if untreated. The surgical team, led by Mohamed A.M. Labib, MD, CM, accessed the tumor by cutting through the conjunctiva inside the lower eyelid, removing the eye socket’s bottom and part of the cheekbone and carefully avoiding damage to the eye, eustachian tube, and major blood vessels. Post-tumor removal, Kalpesh Vakharia, MD, MS, reconstructed the eye socket with a titanium plate and the cheek with hip bone, leaving no external scars. Despite some residual nerve damage affecting left eye movement, the patient’s prognosis is excellent following proton therapy.

This case reinforces the importance of thorough investigation of visual symptoms, as double vision was critical to early detection. It also highlights the potential for transorbital approaches in complex surgeries, offering insights for ophthalmologists collaborating in multidisciplinary settings.

My Two Cents

Woahhhhh, this is amazing! What a novel way to get through to the spinal cord. Kudos to those Terps over at UMMC for coming up with such a unique procedure. It’s also noteworthy that the rare chordoma tumor was first identified following the patient’s initial symptom of double vision. The ever-dreaded patient complaint of double vision actually ended up being true double vision and not just “blur,” which is so often the case in my clinic. Remember to take all patient complaints of double vision very seriously, as it could very well be the result of an issue like this!

CAN YOU RELATE

As you undoubtedly heard, the Catholic church recently announced its new pope, Cardinal Robert Prevost, herein known as Pope Leo XIV—the first ever American pope in the Catholic Church’s 2,000+ year history! He’s one of us. (Even if you’re from Canada, it’s close enough.) Not only that, he’s from the Midwest, which warms my heart as well.

Why is this important? Well, in the grand scheme of things, it’s not, really. But it really does underscore the potential of everyone with whom we come in contact. Those friends and classmates from optometry school who you spent nearly each day with for roughly 3 years? One of them could be the brains behind the next big innovation in our profession! Encourage them!

One of your pediatric patients may be so moved by your compassion or care they may end up following in your footsteps. Heck, they may end up taking over for you when you retire! It’s crazy to think about, but it happens! We need to remember that every person we encounter has limitless potential. Any chance you get, be kind and nurture and feed the curiosity and hunger in those around you. They may be capable of bringing great things our way. You never know when you could be speaking to the next president of the United States, president of the American Optometric Association, or even the next pope!