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U.S. Department of Health and Human Services

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

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JOHNSON & JOHNSON VISION CARE, INC. - US ACUVUE® VITA¿ LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Catalog Number ATL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Corneal Scar (1793); Eye Infections (4466)
Event Date 07/01/2021
Event Type  Injury  
Event Description
On (b)(6) 2021 an eye care provider (ecp) in (b)(6) called to report a patient (pt) has scarring on the eye (affected eye is unknown) while wearing the acuvue® vita¿ brand contact lenses (cls). The ecp advised the lenses tore on the pts eye. The pt had to visit a hospital, had an ¿infection¿ and wore eyeglasses for 2 weeks. The pt was prescribed floxal, fml liquid film, lacry, tobrex. The medication details and frequency of the prescribed medication are unknown. The reporting ecp didn¿t have the exact date the pt visited the hospital. The ecp reported the event occurred sometime after (b)(6) 2021. No additional medical information was provided. On (b)(6) 2021 additional medical information was provided. The affected eye is the od. The pt was prescribed floxal, fml liquid film, lacry and tobrex for 14 days. The pt has no loss of visual acuity and has returned to cls wear. The pt contacted the ecp regarding the event on (b)(6) 2021, but the date of the event was not provided. No additional medical information has been received. No additional medical information is expected. 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 b00x66p was produced under normal conditions. The od suspect cls was discarded. No additional evaluation can be conducted. If any further relevant information is received, a supplemental report will be filed.
 
Manufacturer Narrative
Suspect product discarded.
 
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Brand NameACUVUE® VITA¿
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
JOHNSON & JOHNSON VISION CARE, INC. - US
7500 centurion parkway
jacksonville FL 32256
Manufacturer Contact
helene aguilar
7500 centurion parkway
jacksonville, FL 32256
9044433835
MDR Report Key13029104
MDR Text Key287912276
Report Number1057985-2021-00179
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K160212
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 12/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberATL
Device Lot NumberB00X66P
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/24/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/17/2021 Patient Sequence Number: 1
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