MAUDE Adverse Event Report: ALCON RESEARCH, LLC. AIR OPTIX PLUS HYDRAGLYDE CONTACT LENS; LENSES, SOFT CONTACT, EXTENDED WEAR

Lot Number 10557006

Device Problems Product Quality Problem (1506); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 01/28/2022

Event Type  malfunction  

Event Description

I ordered contacts from (b)(6) website.The contacts were delivered today and upon inspection the boxes had blue stickers on them.They were not adhered very well so i peeled them back.The contact box says "for sale in (b)(6) only." upon closer inspection, the boxes do not have an english on them besides the brand name and line the contacts come from.All other information is in a different language.All 4 boxes i ordered have the blue sticker on them and all 4 says "for sale in (b)(6) only." the packaging is also different then what is advertised on the website and what the manufacturer shows the packaging should be.The company claims to be a usa based business out of (b)(6) and the box was shipped from (b)(6).I will be returning the product.(or trying too).Fda safety report id# (b)(4).

• Brand Name: AIR OPTIX PLUS HYDRAGLYDE CONTACT LENS
• Type of Device: LENSES, SOFT CONTACT, EXTENDED WEAR
• Manufacturer (Section D): ALCON RESEARCH, LLC.
• MDR Report Key: 13425091
• MDR Text Key: 285013923
• Report Number: MW5107136
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/28/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 10557006
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White