• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Iritis (1940); Irritation (1941); Discomfort (2330)
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
On (b)(6) 2019, a representative from an eye care provider¿s (ecp) reported that a patient (pt) was diagnosed with iritis while wearing acuvue® vita¿ brand contact lenses (cl). The pt was diagnosed with iritis in both eyes (ou) in (b)(6) 2018. The pt experienced ¿lots of irritation and discomfort¿ and wearing the cls made it worse. The pt visited the ecp several times due to the irritation and discomfort. The pt is currently wearing a different brand of cls. The representative refused to provide any additional medical information. No additional medical information is expected to be received. The suspect lens is not available for return. The representative reported lot # b00p9n8 and lot # b00q02x, but refused to provide which lot # is for the pt's right eye (od) or left eye (os). This report will reflect both lot #'s reported. 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 b00p9n8 was produced under normal conditions. 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 b00q02x was produced under normal conditions. If any further relevant information is received, a supplemental report will be filed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key8279633
MDR Text Key134241825
Report Number1057985-2019-00011
Device Sequence Number1
Product Code LPL
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K160212
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberATL
Device Lot NumberUNK-ATL
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/03/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/25/2019 Patient Sequence Number: 1
-
-