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U.S. Department of Health and Human Services

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

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JOHNSON & JOHNSON VISION CARE, INC. - US ACUVUE® VITA¿ FOR ASTIGMATISM LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Catalog Number AAS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Corneal Scar (1793); Red Eye(s) (2038)
Event Date 09/01/2021
Event Type  Injury  
Event Description
On 18oct2021 an email received from a distributor advised an eye care provider (ecp) in (b)(6) reported a patient (pt) was diagnosed with redness and corneal opacities while wearing the acuvue® vita¿ for astigmatism brand contact lenses (cls). On 26oct2021 the reporting ecp provided additional medical information. The event occurred in (b)(6) 2021. The pt reported redness after using the lenses for 3 to 4 hours ou. After 4 days both eyes were still red. The ecp diagnosed the pt with corneal opacities in od and the os and the pt was referred to an ophthalmologist. The treatment is unknown. The ophthalmologist advised the pt not to use the lenses as a ¿resolution¿ and after 15 days, the pts eyes were fine. The ecp advised the ophthalmologist refused to share any additional details. No additional medical information was provided. 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 b00nxhm was produced under normal conditions. This report is being submitted for the pts os event. The event for the pts od will be submitted in a separate report. The suspect os 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¿ FOR ASTIGMATISM
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
JOHNSON & JOHNSON VISION CARE, INC. - US
7500 centurion parkway
jacksonville FL 32256
Manufacturer Contact
richard holmes
7500 centurion parkway
jacksonville, FL 32256
9548020487
MDR Report Key12782833
MDR Text Key282126096
Report Number1057985-2021-00170
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K160212
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/01/2022
Device Catalogue NumberAAS
Device Lot NumberB00NXHM
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/21/2017
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: 11/09/2021 Patient Sequence Number: 1
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