Hubble Contacts concerns grow after woman loses eye, AOA asks where’s enforcement?

Hubble Contacts faces legal woes anew after a customer loses her eye, alleging product liability, with the AOA mounting pressure on federal regulatory and health agencies to take “real action” that keeps Americans safe.

Emergence of the 31-page lawsuit against Vision Path, Inc., doing business as Hubble Contacts, in June drew the immediate attention of not only media outlets but also optometry’s advocates as the AOA and affiliates had spent years documenting and sharing cases of patient harm related to Hubble Contacts’ products and business practices with market regulators. While these advocacy efforts culminated in 2022 with a $3.5 million settlement between Hubble Contacts and federal agencies over breaches to federal law, the AOA maintained that strict enforcement was still needed to allay serious health risks.

            ⏩ How the AOA is responding to the Hubble Contacts lawsuit.

That admonition may have been sadly validated a year later when a New Mexico woman claimed she sustained severe and permanent injuries mere weeks after using the brand’s lenses that resulted in repeated medical visits and, ultimately, total loss of her right eye, noted AOA President Ronald L. Benner, O.D., in a letter sent to the Federal Trade Commission (FTC) and Food and Drug Administration (FDA) weeks after news of the patient’s lawsuit.

“The 2022 settlement alone is not sufficient, and we are concerned that the FDA and FTC’s ongoing leniency toward Hubble Contacts continues to put the American public at risk. Stronger, more meaningful action is direly needed,” the AOA letter reads.

Per the lawsuit, the woman claims she purchased Hubble Contact lenses using an eyeglass prescription in 2020 and alleges that verification and provider information was not required at the time of order. The lenses arrived with no care or wear instructions, the complaint alleges, and after a half dozen times wearing the product, she stopped using the lenses only a few months later. Only weeks after ceasing wear, she developed a “corneal ulcer and perforated multiorganism infection with near total melt and extrusion of lens,” believed to be derived from contact lens wear. After months of procedures, the woman underwent a complete removal of her right eye and continues to seek care.

The lawsuit alleges Hubble Contacts lenses “were unsafe, defective and inherently dangerous in that the contact lenses were subject to a high rate of eye infections and corneal damage during normal and customary use since Defendant did not verify prescriptions and instead used a ‘one size fits all’ base curve measurement.” This, despite the fact that other lens designs were available.

Time to take ‘real action’ to keep the public safe

In that letter sent to the FTC and FDA on July 20, the AOA argued meaningful enforcement action is overdue not only given Hubble Contacts’ track record of exploiting the very market and patient safety regulations it was penalized for violating in 2022, but also for the scores of documented cases of patient harm or suspected breaches of market laws flagged by the AOA, affiliates and eye care providers over the years.

In 2017, the AOA first requested investigation of Hubble by the FTC, Department of Justice (DOJ) and the Postal Inspection Service on suspected violations of the Racketeer Influenced and Corrupt Organizations statute, Fairness to Contact Lens Consumers Act (FCLCA) and Contact Lens Rule, and mail fraud. This was followed by a request for additional information from the FDA over a warning letter the agency sent to Hubble’s then lens manufacturer, St. Shine Optical, for facility and manufacturing violations, in addition to the AOA’s flagging of a statement on Hubble’s website that claimed such lenses were not significantly different than other popular U.S. brands.

In subsequent years, the AOA transmitted to the FTC over 80 documented cases of suspected patient harm and possible violations of the FCLCA and Contact Lens Rule regarding Hubble. Such activity even drew the attention of a media exposé that independently validated the AOA’s concerns.

But it wasn’t until 2022 that the DOJ and FTC announced Hubble (Vision Path, Inc.) would pay $1.5 million in civil penalties, $2 million in consumer redress and subject the online contact lens seller to ongoing compliance monitoring and a full range of operating restrictions as part of a settlement to resolve allegations that the company repeatedly violated the FCLCA, Contact Lens Rule and the FTC Act. Months later, Texas Attorney General Ken Paxton also announced a settlement with Hubble (Vision Path, Inc.) whereby the company would pay $300,000 in civil penalties, including refunding two dozen Texas consumers.

These settlements reflected a sustained, years-long effort by the AOA, state affiliates and member doctors nationwide to sound an alarm over potential patient health and safety threats. However, while the AOA was relieved to see that the FTC and DOJ had finally taken some action to address these violations, the AOA harks back to a statement within the 2022 settlement that “absent injunctive relief by this Court, [Hubble Contacts] is likely to continue to injure consumers and harm the public interest.”

⏩ What can doctors do to support the AOA’s contact lens advocacy?

The recent AOA letter to the FDA and FTC also notes that the partnership between Hubble Contacts and the online vision testing company Visibly (formerly Opternative) raises further red flags; “consumers who have never been fit with Hubble Contacts are being encouraged to switch to the Hubble Contacts brand,” the letter states.

“Given the well documented health care risks of Hubble Contacts’ unethical business practices, we are very concerned that FTC and FDA are allowing the company to use Visibly to attract customers and to subvert the contact lens evaluation and fitting process,” the AOA letter reads.

Although Visibly received FDA approval to use its product for individuals 22 to 40 years old, the company continues to leverage a COVID-19 enforcement waiver to offer its product outside these bounds to individuals 18-55 years old, and the company says as much on its website.

Essentially, these companies have been given a green light to operate almost entirely without regulatory oversight, the AOA contends, and Hubble Contacts has even touted a relationship with FTC staff to bolster the company’s credibility by claiming the regulator’s satisfaction with its changes.

“The reality is that the American public is freely able to seek contact lenses from Hubble that have never been prescribed by a doctor through an online vision testing system that has not received FDA approval to determine whether it is safe and effective,” the AOA letter concludes. “The AOA is seeking immediate action by FDA and FTC to address this serious and concerning business partnership.”

How you can support the AOA’s contact lens advocacy

Contact lenses are a safe, effective vision correction option when worn and cared for properly. However, poorly fitted or improperly used contact lenses can result in serious eye health and vision complications, which is why these FDA-regulated medical devices require oversight and prescription from an eye doctor as outlined by the FCLCA and Contact Lens Rule.

The AOA takes seriously its mission to serve as not only a reliable public source of information on issues affecting Americans’ eye health and vision care but also a resource for helping doctors safeguard their patients’ eyesight. Toward that end, the AOA regularly meets with federal regulatory officials to urge that more be done to crack down on dishonest internet and direct-to-consumer sellers, efforts bolstered by informed reports from doctors nationwide.

Better documentation of illegal contact lens transactions helps the AOA build a case for increased enforcement by federal regulators. Here’s how doctors can support the AOA’s contact lens advocacy by reporting illegal sales or adverse events:

• Report unlawful sales of medical products on the internet.
• Report suspicious business practices with the FTC complaint assistant.
• Report adverse reactions or problems with contact lenses.

Additionally, doctors are encouraged to complete this form when encountering such issues to arm the AOA with actionable data for regulators. For questions or more information, please contact StopIllegalCLs@aoa.org.