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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 Pain (1994); Red Eye(s) (2038); Uveitis (2122)
Event Date 12/20/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
On (b)(6) 2018, a patient (pt) called to report ¿lasting redness¿ while wearing the acuvue oasys 1 day with hydraluxe brand contact lens. The pt recently changed from the acuvue oasys brand contact lens to the acuvue oasys 1 day with hydraluxe brand contact lens. On day 6, the pt noted a ¿prickly¿ feeling in the od. The pt removed the suspect od lens on arrival home but the ¿prickly¿ sensation, photophobia and eye pain continued. The pt went to sleep for a few hours and the symptoms worsened. The pt went to the eye care provider (ecp) the next day and was diagnosed with od uveitis. The pt was prescribed prednisolone eye drops qid for 6 days. The pt will follow-up with the ecp next week and reports will likely be put on a taper schedule for the eye drops. The pt reported the od was feeling much better today after starting the prednisolone eye drops, but still has some photophobia. The pt has not had a diagnosis of uveitis in the past. The pt does not sleep in the lenses. Multiple calls were placed to the pts treating ecp¿s office and additional medical information was requested, but no information was provided. No additional medical information has been received. The suspect od contact lens was discarded by the pt. No evaluation can be conducted. 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 j001scn was produced under normal conditions. If any further relevant information is received, a supplemental report will be filed.
 
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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 Key8249907
MDR Text Key133227555
Report Number1057985-2019-00007
Device Sequence Number1
Product Code LPL
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K042275
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 12/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberTSP
Device Lot NumberJ001SCN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/21/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/09/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/15/2019 Patient Sequence Number: 1
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