MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ US ACUVUE VITA; SOFT CONTACT LENS, DAILY WEAR

Catalog Number ATL

Device Problem No Apparent Adverse Event (3189)

Patient Problem Corneal Ulcer (1796)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On 11oct2017 a johnson and johnson sales representative called to report that a patient at an eye care providers (ecp) office was diagnosed with ¿borderline ulcers¿ while wearing the acuvue vita brand contact lenses.The representative did not have the details of the event, but provided the ecp contact details for additional information.Calls were placed to the ecps office on 12oct2017, 17oct2017 and 25oct2017 for additional medical and product information, but no return calls have been received.On 25oct2017 a call was placed to the sales representative and advised that no return calls have been received from the ecp.The representative reported he/she will go to the ecps office on 26oct2017 and request the ecp to call with details of the event.No additional medical information has been received.The date of the event is unknown.This event is being reported as a worst-case event as no return call was received from the pts treating ecp to verify the diagnosis and treatment.The lot number and the suspect product availability for return are unknown.If additional information is received it will be reported within 30 days of receipt.Serious reportable event trends are reviewed quarterly in franchise management review meetings.

• Brand Name: ACUVUE VITA
• Type of Device: SOFT CONTACT LENS, DAILY WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. ¿ US; 7500 centurion parkway; jacksonville FL
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 6999049
• MDR Text Key: 90975606
• Report Number: 1057985-2017-00125
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: ATL
• Device Lot Number: UNK-ATL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2017
• Initial Date FDA Received: 11/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention