MAUDE Adverse Event Report: VISTAKON/ JOHNSON AND JOHNSON ACUVUE 1 DAY MOIST CONTACTS

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/12/2017

Event Type  No Answer Provided  

Event Description

We were called by robot call from (b)(6) for a renewal of contacts for the patient.It was the wrong rx so i called the patient and she told me that she did not order from them.She called them and they said that they were reordering the contacts even though she did not request the reorder.

• Brand Name: ACUVUE 1 DAY MOIST CONTACTS
• Type of Device: CONTACTS
• Manufacturer (Section D): VISTAKON/ JOHNSON AND JOHNSON; FL
• MDR Report Key: 7013668
• MDR Text Key: 91914119
• Report Number: MW5073209
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 44 YR