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 Date 03/20/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2018 a patient (pt) called to report a diagnosis of corneal ulcer od while wearing the acuvue vita brand contact lens.The pt reported the lenses are tearing after one day of wear.Pt went to an eye care provider (ecp) who diagnosed the od corneal ulcer (date of visit was unknown) and reports a follow-up visit tomorrow.Pt reported wearing a 1 week trail of the acuvue vita brand contact lenses without issue, but reports the lenses tearing since (b)(6) 2018.Pt could not recall the date of the recent corneal ulcer event.No additional medical information was received.On 31may2018 a call was placed to the pts ecp and a representative provided additional information: -pt reported the acuvue vita brand contact lenses had been tearing soon after opening a new contact lens package.Pt was diagnosed with an od corneal ulcer on (b)(6) 2018.The pt was refit with a competitor brand contact lens on (b)(6) 2018 and allowed to return to contact lens wear.No additional medical information was provided.Multiple attempts were made to contact the pt for additional information, but no additional information has been received.It is unknown if the suspect lens is available for return for evaluation.A lot history review was performed and revealed the following: the batch record did not show any abnormalities in monomer and solution testing.All parameters tested were within specification.All sterilization requirements were successfully completed.Lot b00mdk8 was produced under normal conditions.If any further relevant information is received, a supplemental report will be filed.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: 7558605
• MDR Text Key: 109740445
• Report Number: 1057985-2018-00078
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/01/2021
• Device Catalogue Number: ATL
• Device Lot Number: B00MDK8
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2016
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention