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

Device Problem Break (1069)

Patient Problem Visual Impairment (2138)

Event Date 11/17/2011

Event Type  Injury  

Event Description

I am from (b)(6), was told for years i was dealing with an eye doctor only to find out they have been illegally been selling me contact lenses for years.Everyone i know has been going there, and not too long ago i almost lost my eyes due to some damaged contacts.

• Brand Name: ACUVUE CONTACT LENS
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): JOHNSON AND JOHNSON VISION CARE INC.
• MDR Report Key: 13111443
• MDR Text Key: 282991820
• Report Number: MW5106330
• Device Sequence Number: 1
• Product Code: LPL
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 19 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Hispanic
• Patient Race: White