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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON AND JOHNSON VISION - USA UNK-SOFT CONTACT LENSES

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JOHNSON AND JOHNSON VISION - USA UNK-SOFT CONTACT LENSES Back to Search Results
Catalog Number UNK-SOFT CONTACT LENSES
Device Problem No Apparent Adverse Event (3189)
Patient Problem Uveitis (2122)
Event Type  Injury  
Manufacturer Narrative
(b)(6).
 
Event Description
On (b)(6) 2018 a patient (pt) reported that she had been diagnosed with uveitis while wearing an unspecified brand of contact lenses in 2014 while residing in the (b)(6). On (b)(6) 2018 the pt was contacted to obtain additional information about the 2014 event, but she stated that she cannot provide any further information and her medical records were left in (b)(6). The pt stated that she will ask her mother in (b)(6) if she can send the medical records. No additional information has been received. The suspect product is not available for return, as it was discarded. No product or lot information was available. No analysis could be conducted. (b)(4).
 
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Brand NameUNK-SOFT CONTACT LENSES
Type of DeviceUNK-SOFT CONTACT LENSES
Manufacturer (Section D)
JOHNSON AND JOHNSON VISION - USA
7500 centurion parkway
jacksonville FL
Manufacturer Contact
rose harrell
7500 centurion parkway
jacksonville, FL 32256
9044433364
MDR Report Key7400776
MDR Text Key104531976
Report Number1057985-2018-00039
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,other
Reporter Occupation
Type of Report Initial
Report Date 03/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK-SOFT CONTACT LENSES
Device Lot NumberUNK-UNK-SOFT CONTACT LENSES
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/16/2018
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: 04/05/2018 Patient Sequence Number: 1
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