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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. - US UNK-SOFT CONTACT LENSES

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JOHNSON & JOHNSON VISION CARE, INC. - US UNK-SOFT CONTACT LENSES Back to Search Results
Catalog Number UNK-SOFT CONTACT LENSES
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Corneal Ulcer (1796); Fungal Infection (2419); Eye Pain (4467)
Event Date 08/28/2021
Event Type  Injury  
Manufacturer Narrative
Unknown product availability.
 
Event Description
On 24oct2021 during a routine review of the fda maude database, voluntary medwatch report # mw5104266 was discovered. The initial reporter advised that a patient (pt) was diagnosed with ¿fungal keratitis due to sleeping in contact lenses. ¿ the date of the event is reported as (b)(6) 2021. ¿patient problems: pain. ¿ it is unknown which eye was the affected eye. No contact name or information was provided. No additional information can be obtained. It is unknown what acuvue daily contact lens brand was worn at the time of the event. The lot number of the suspect product was not provided. It is unknown if the suspect product is available for return for evaluation. No additional evaluation can be conducted. If any further relevant information is received, a supplemental report will be filed.
 
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Brand NameUNK-SOFT CONTACT LENSES
Type of DeviceUNK-SOFT CONTACT LENSES
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 Key12790186
MDR Text Key280810537
Report Number1057985-2021-00172
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 03/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK-SOFT CONTACT LENSES
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 11/10/2021 Patient Sequence Number: 1
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