MAUDE Adverse Event Report: MOODY GLOBAL LIMITED MOODY SOFT CONTACT LENSES; LENSES, SOFT CONTACT, DAILY WEAR

Model Number	LONG ISLAND
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Mislabeled prescription contact lenses: on (b)(6) 2024, i received a prescription from my ophthalmologist for a pair of prescription contact lenses named "long island blue" manufactured by "moody lenses us" and on (b)(6) 2024, i ordered and purchased these contact lenses from moody via their online store (https://www.Moodylenses.Com/us).On (b)(6) 2024, moody fulfilled my order, shipped my lenses, and emailed me a paid invoice clearly listing on my invoice the "long island blue" contact lenses that i ordered.On (b)(6) 2024, i received my shipment from moody containing the contact lenses.Inside the shipment were two (2) small boxes, one box labeled "long island blue 3.50", and a second box labeled "long island blue 3.75".However, upon opening each box i noticed that the plastic contact lens case containing each contact lens was labeled differently than its outer box.The contact lens case whose box was labeled as "long island blue 3.50" was labeled "barbie gray 3.50" while the contact lens case whose box was labeled as "long island blue 3.75" was labeled as "barbie gray 3.75".I then went to moody's website and identified that "barbie gray" is a completely different model and color of contact lens that moody sells on their website.On (b)(6) 2024, i emailed moody's customer support team (info@moody-lenses.Com) and informed them of the problem with my contact lens order, which included a photo of both contact lens boxes, and their respective, mislabeled, plastic contact lens case.On (b)(6) 2024, moody responded to my email stating that "we have double checked your order in our system, and it seems that we shipped the correct products.According to your picture, the product name identified that the product is long island.Please kindly note that barbie is not the name of the product.Sorry for the confusion".On (b)(6) 2024, i responded to moody's customer support team asking them to take a closer look at the printing on each plastic contact lens case and compare it to the printing on each case's respective contact lens box, which does not match.In my email, i highlighted for them in "yellow" the printing on each plastic contact lens case.On (b)(6) 2024, moody responded to my email stating "we were informed that "barbie" is a label signed by our supplier, it does not mean the style.All the lenses in this batch have this mark.Please rest assured that we sent you the right [long island].If you still have concern, you can flip over the lenses and check the color".However, upon review of moody's website, this statement is obviously inaccurate because moody's website sells another contact lens named "barbie gray".As for verifying the color of the lenses, the plastic case that the lenses are packaged in is somewhat opaque (i.E., cloudy) making it difficult to clearly determine the true color of the lenses without opening its seal, which would then void any return possibility.On (b)(6) 2024, i shared the mislabeled contact lens information from moody with my ophthalmologist who strongly advised me not to wear contact lenses whose case label does not match the label on its respective box.He further recommended that i file a complaint with the us food & drug administration (fda) if the manufacturer refused to correct the situation.Further communications with moody resulted in them offering me a partial refund if i didn't file a complaint with the fda and destroyed the lenses, which i declined.Ref report: mw5152654.

• Brand Name: MOODY SOFT CONTACT LENSES
• Common Device Name: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): MOODY GLOBAL LIMITED; 8 the green ste a; dover DE 19901
• MDR Report Key: 18886597
• Report Number: MW5152653
• Device Sequence Number: 8982394
• Product Code: LPL
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 03/07/2024

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
• Device Model Number: LONG ISLAND
• Device Catalogue Number: 60700091350
• Device Lot Number: U231216010314
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/11/2024
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PRESCRIPTION CONTACT LENSES
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White