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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ US ACUVUE OASYS1 DAY WITH HYDRALUXE TECHNOLOGY LENSES, SOFT CONTACT

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JOHNSON & JOHNSON VISION CARE, INC. ¿ US ACUVUE OASYS1 DAY WITH HYDRALUXE TECHNOLOGY LENSES, SOFT CONTACT Back to Search Results
Catalog Number TSP
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Irritation (1941); Swelling (2091)
Event Type  Injury  
Manufacturer Narrative
(b)(4). (b)(6).
 
Event Description
On (b)(6) 2018 a call was received from an eye care provider (ecp) in italy who reported a patient (pt) had a ¿severe allergic reaction¿ to the acuvue oasys®1 day with hydraluxe¿ brand contact lenses within 5 minutes of insertion of the suspect lens. The pts eye (affected eye not provided) was swollen and the pt had an ¿anaphylactic shock and almost went into a coma¿. The pt allegedly went to a local hospital for evaluation. The event occurred 2 weeks ago, (b)(6) 2018. The pt discontinued use of the contact lenses (cl). The reporting ecp provided limited information; the ecp did not examine or treat the pt. On (b)(6) 2018 a johnson and johnson physician contacted the reporting ecp to request additional information. The ecp reported irritation and after the patient removed the suspect lens, there were no further issues. No additional medical information was provided. On (b)(6) 2018 the johnson and johnson physician received additional information from the reporting ecp. The ecp was able to contact the pt. The pt reported that they did not seek medical treatment or receive any medication after the reported event. No additional information is expected to be received. The lot number of the suspect product unknown. The suspect lens was discarded and not available for return for evaluation. This event is being reported as a worst-case event as it was unconfirmed if the pt sought medical intervention or treatment at the time of the event. If any further relevant information is received, a supplemental report will be filed. Serious reportable event trends are reviewed quarterly in franchise management review meetings.
 
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Brand NameACUVUE OASYS1 DAY WITH HYDRALUXE TECHNOLOGY
Type of DeviceLENSES, SOFT CONTACT
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 Key8081296
MDR Text Key127543015
Report Number1057985-2018-00136
Device Sequence Number1
Product Code LPL
Combination Product (y/n)Y
Reporter Country CodeIT
PMA/PMN Number
K042275
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 10/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberTSP
Device Lot NumberUNK-TSP
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 Received10/24/2018
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?
Type of Device Usage

Patient Treatment Data
Date Received: 11/16/2018 Patient Sequence Number: 1
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