MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC ACUVUE LENS; LENSES, SOFT CONTACT, DAILY WEAR

Device Problem Defective Component (2292)

Patient Problem Blurred Vision (2137)

Event Date 06/18/2020

Event Type  malfunction  

Event Description

I bought contact lens through (b)(6).Returned lens with form because they're defected.Explained lenses are blurry.Currently have the same prescription that was provided.This company will not refund me, its asking for a new script and that the acuvue manufacturer won't accept without this information.Acuvue manufacturer website clearly refund no questions asked.

• Brand Name: ACUVUE LENS
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC
• MDR Report Key: 10407152
• MDR Text Key: 203153233
• Report Number: MW5096066
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): Y
• 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: 08/11/2020

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 Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 19 YR
• Patient Weight: 77