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U.S. Department of Health and Human Services

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

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JOHNSON & JOHNSON VISION CARE, INC. ¿ US ACUVUE VITA SOFT CONTACT LENS, DAILY WEAR Back to Search Results
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
Evaluation codes: (b)(4). Initial reporter's phone number: (b)(6).
 
Event Description
On 06jan2020 a johnson and johnson sales representative in thailand 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 (b)(6) 2020 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 os contact lens was discarded. No additional investigation can be conducted. This report is for the os event. A separate report will be filed for the od event. If any further relevant information is received, a supplemental report will be filed.
 
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Brand NameACUVUE VITA
Type of DeviceSOFT 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 Key9644311
MDR Text Key190473983
Report Number1057985-2020-00008
Device Sequence Number1
Product Code LPL
Combination Product (y/n)Y
Reporter Country CodeTH
PMA/PMN Number
K160212
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
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 Received01/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberATL
Device Lot NumberB00T89H
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/15/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/29/2020 Patient Sequence Number: 1
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