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 (b)(6) 2017 a patient (pt) called to report he/she had ¿severe issues¿ with the acuvue vita brand contact lenses.A return call was placed to the pt who reported he/she was on the way to an eye care providers (ecp) appointment as pt had an ¿eye ulcer¿ from the vita contact lenses.On 29aug2017 a return call was placed to the pt and the additional information was provided as follows: pt reported he/she was wearing the lenses daily.Pt stated the ¿ulcer¿ started to occur and the pt did not wear lenses for seven days, then went to the ecp.Pt reported an ecp visit on (b)(6) 2017.Pt reported the lenses started hurting on (b)(6) 2017 and the suspect lenses were removed and then reinserted the lenses on the (b)(6) 2017 when he/she went to the ecp.The pt was prescribed an antibiotic eye drop (medication name was not provided) every two hours for seven days and is still using the eye drops qid in the os.The pt reported he/she has stopped using the acuvue lenses.The pt reported that he/she was advised by the ecp that he/she ¿had this issue because she was consistently wearing the lenses¿.The pt reported the ecp told the pt he/she could wear the vita brand contact lenses overnight, but he/she ¿tries to wear them how they¿re supposed to be.¿ the pt refused to provide the treating ecp information and did not want the ecp contacted.No additional medical information was provided.The event date is (b)(6) 2017.The lot number was not provided.The suspect lenses were requested for return, but have not been received.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: 6887058
• MDR Text Key: 87201268
• Report Number: 1057985-2017-00112
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/28/2017

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
• Initial Date Manufacturer Received: 08/28/2017
• Initial Date FDA Received: 09/22/2017
• 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