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

Catalog Number ATL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Corneal Ulcer (1796); Dry Eye(s) (1814); Irritation (1941)

Event Date 01/04/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter's phone number: (b)(6).

Event Description

On (b)(6) 2020 a johnson and johnson sales representative in (b)(6) reported a patient (pt) experienced dry eye and corneal ulcer (affected eye unknown) while wearing the acuvue® vita¿ brand contact lens.The pt is currently wearing glasses.No additional medical information was provided.On 06jan2020 a call was placed to the pts eye care provider (ecp) who provided additional information: the ecp reported the event occurred (b)(6) 2020 and that both eyes were affected.The pt experienced dry eye on the 3rd day of contact lens wear.The pt visited the treating ecp who diagnosed the pt with dry eye and corneal ulcer.The ecp recommended the pt stop wearing lenses for about a month.The pt was advised the eyes are dry and the pt should wear a daily contact lens instead.The ecp will contact the pt for additional medical information.On 08jan2020 a call was placed to the pt who provided additional medical information: the pt reported the date of the event was (b)(6) 2020, the 3rd day of contact lens wear.The pt advised both eyes were affected.The pt last visited the ecp on (b)(6) 2020.The pt reported the diagnosis provided by the ecp was ¿serious dry eye and pt pupils were scratched.¿ the pt reported the pupils were scratched due to the dryness.The pt reports symptoms of eye heaviness and eye pinching with the symptoms continuing.The treating ecp prescribed ¿1 liquid eye drop and 1 gel drop¿ every night and artificial tears drops to apply hourly.The name of the prescribed medications were unknown at the time of the call.The pt will visit the ecp on sunday ((b)(6) 2020) and will provide the medical report from the ecp visit.On 10jan2020 the pt was contacted and will provide the prescribed medications.No further information was provided.On 23jan2020, additional information was received from the johnson and johnson affiliate: the patient (pt) has not returned to visit the eye care provider (ecp).The pt provided the names of the medications used: hylo-comod, every 1 hour (artificial tears); restasis, instill 1-2 drops 2 times a day (the pt has already stopped using); solcoseryl eye gel, apply once a day.The pt reported an appointment to the ecp this week (unspecified date).No further information was provided.On 29jan2020, additional information was received from the johnson and johnson affiliate: the pt visited the ecp today and was advised to return to the ecp again on (b)(6) 2020.No further information was provided.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 b00t89h was produced under normal conditions.The suspect od contact lens was discarded.No additional investigation can be conducted.This report is for the od event.A separate report will be filed for the os event.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

On (b)(6) 2020 the patient (pt) provided the medical certificate with additional medical information.The pt went to see the eye care provider (ecp) on (b)(6) 2020 and had dry eye syndrome.Medical certificate exam date: (b)(6) 2020; diagnosis: h04.1, other disorder of lacrimal gland, dacryops dry eye syndrome lacrimal; cyst ¿ gland atrophy.Dry eye; the eye care provider recommended the pt to take leave 1 day, (b)(6) 2020.The pt has a follow-up eye appointment on (b)(6) 2020.No additional medical information was provided.This report is for the od event.A separate report will be filed for the os event.If any further relevant information is received, a supplemental report will be filed.

• 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
• MDR Report Key: 9644331
• MDR Text Key: 190384158
• Report Number: 1057985-2020-00009
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): Y
• PMA/PMN Number: K160212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• 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: B00T89H
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention