MAUDE Adverse Event Report: MENICON CO. LTD. ACUVUE ABILITI OVERNIGHT THERAPEUTIC LENSES FOR MYOPIA MANAGEMENT; LENS, CONTACT, ORTHOKERATOLOGY, OVERNIGHT

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

I noticed that the acuvue abiliti overnight therapeutic lenses for myopia management includes instructions for use that are inconsistent with the indications for which the device was approved.The name of the product itself also includes false representations by indicating unsubstantiated claims of therapeutic value.The original pma (p990018) was issued in 1999 and was supplemented to include orthokeratology lenses in 2019, and then in 2021 a further supplement was approved to add the private label trade name (acuvue abiliti overnight therapeutic lenses for myopia management ) to the pma.Shortly thereafter on may 12, 2021 johnson & johnson issued a press release (https://www.Jjvision.Com/press-release/johnson-johnson-vision-announces-fda-approval-acuvuer-abilititm-overnight-0) announcing that the ortho-k lenses have been approved for "myopia management" with a footnote citing the instructions for use filed with the fda.While the change in indications for the medical device are not included on the fda website, the original pma indicates the usage as being for refractive correction, rather than "myopia management".We have reviewed a subsequent version of the device ifus dated may 24, 2022, which now specify that the lenses are fda approved for the "correction and control of myopia".While both "myopia management" and "myopia control" are relatively vague terms, the general usage in the market today for both terms is in relation to slowing the progression of myopia or in slowing eyeball elongation.See for example misight daily use contact lenses, which received the first fda approval for an indication to slow the progression of nearsightedness in children.(https://www.Fda.Gov/news-events/press-announcements/fda-approves-first-contact-lens-indicated-slow-progressionnearsightedness- children#:~:text=fda%20approved%20the%20first%20contact%20lens%20to%20slow,for%20children%208-12%20at%20the%20start%20of%20treatment.) johnson & johnson may be taking the position that refractive correction is one part of a broader field of myopia management or myopia control, the addition of the term "therapeutic lenses for myopia management" it clearly leads the user to believe that the 2021 pma supplement was approval for use in slowing the progression of myopia.(see for example https://www.Hcplive.Com/view/fda-approves-orthokeratology-contact-lenses-for-myopia-management).If the fda reviewed the supporting clinical trial data, and specifically have approved the lenses with the indication of slowing the progression of myopia in children, then i think that it is important to note that has been clearly added to the pma.If it the indication has been approved but not added to the pma, then it leads to market confusion.On the other hand, if the additional indication was not intended to be added, then the j&j materials are misleading or false representations.Similarly, if the fda has approved the additional indication for the product, then it is important for the market to have that clearly stated so that the criteria for other competitors for obtaining the indication are clearly understood.This is an important and growing field and it is important that clear standards are upheld to ensure the integrity of the market and protection of the children using the products.

• Brand Name: ACUVUE ABILITI OVERNIGHT THERAPEUTIC LENSES FOR MYOPIA MANAGEMENT
• Type of Device: LENS, CONTACT, ORTHOKERATOLOGY, OVERNIGHT
• Manufacturer (Section D): MENICON CO. LTD.
• MDR Report Key: 18437449
• MDR Text Key: 331985617
• Report Number: MW5149741
• Device Sequence Number: 1
• Product Code: NUU
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/02/2024
• Patient Sequence Number: 1