News: Manufacturing Deviations Prompt Voluntary Recall of Ophthalmic Products
Due to cGMP manufacturing deviations identified during an audit by the US Food and Drug Administration (FDA), pharmaceutical distributor AvKare released an urgent voluntary drug recall announcement on its website for several
ophthalmic products.

The announcement noted that “Health Hazard to the user is unknown, cGMP deviations may lead to products of unacceptable quality, and it is not possible to rule out patient risks resulting from use of these products." 

Additionally, the announcement noted that the recall is being carried out with the knowledge of the FDA, and further use of these products should immediately cease.

The below marketed products are subject to the recall:

• NDC# 50268-043-15 Artificial Tears Ophthalmic Solution
• NDC# 50268-066-15 Carboxymethylcellulose Sodium Ophthalmic Gel 1%
• NDC# 50268-068-15 Carboxymethylcellulose Sodium Ophthalmic Solution
• NDC# 50268-126-15 Lubricant Eye Drops Solution
• NDC# 50268-678-15 Polyvinyl Alcohol Ophthalmic Solution

For more information about the products being recalled, read the full notice here:  https://www.avkare.com/recall  The FDA has also published the number of cases in the recall here: https://www.accessdata.fda.gov/scripts/ires/?Event=96741

Bausch + Lomb Releases Scleral Contact Lenses for Higher-Order Aberrations
Bausch + Lomb announced the U.S. launch of Zenlens Chroma HOA (higher-order aberration) scleral contact lenses. The custom, wavefront-guided scleral lens technology reduces higher-order aberrations and enhances vision by minimizing blurring and distortion, according to a press release. Lens stability is achieved through proprietary Zenlens technologies, including SmartCurve and Bi-Elevation, says Bausch + Lomb. For more information on Zenlens Chroma HOA, visit www.bauschsvp.com/lenses/zenlens.

Coalition of Healthcare Leaders Announce Artificial Intelligence Alliance 
A group of leaders in health care have formed the Alliance for Healthcare from the Eye to “transform disease detection and coordinated care delivery with oculomics and artificial intelligence (AI), according to a press release. Specifically, this consortium of health systems, clinicians, industry innovators, life science companies, nonprofits and policymakers, and payors aim to drive a shift from reactive to proactive healthcare by leveraging ocular data. Michael Chaglasian, OD, FAAO, and Howard Purcell, OD, FAAO, are among the members of this newly formed group. 

Doheny Eye Institute Names Mary D. Allen Endowed Chair in Vision Research
Doheny Eye Institute, a vision research institution, announced that Kaustabh Ghosh, PhD, was awarded the Mary D. Allen Endowed Chair in Vision Research, according to a press release. This is a faculty position supported by a generous gift made to the Institute by Mrs. Allen in 1990. Dr. Ghosh is a principal investigator at Doheny Eye Institute, an associate professor of Ophthalmology at UCLA’s David Geffen School of Medicine, and participating faculty member at UCLA’s Molecular, Cellular, and Integrative Physiology Interdepartmental PhD Program.

The Vision Council Updates Members on Latest Tariff Developments
The Vision Council updated its members on the latest developments regarding tariffs. Specifically, as of May 12, the United States and China have mutually decided to temporarily reduce tariffs on U.S. and Chinese imports for a 90-day period, according to the press release. This means the United States will lower its “reciprocal” tariff assessed against Chinese origin materials from 125% to 10%, while China will decrease its “reciprocal” tariff likewise on U.S. origin exports from 125% to 10%. These reductions officially went into effect on May 14 and are set to expire in August, unless extended through additional negotiations. OM