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U.S. Department of Health and Human Services

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

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JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND 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 Corneal Ulcer (1796); Discomfort (2330)
Event Type  Injury  
Manufacturer Narrative
(b)(4). (b)(6).
 
Event Description
On (b)(6) 2018 a patient (pt) from (b)(6) called to report os eye pain upon inserting the acuvue oasys®1 day with hydraluxe brand contact lens. The pt went to see a doctor who diagnosed an os corneal ulcer. The pt was prescribed tobramycin eye drops and recombinant human epidermal growth factor eye drops to use q 1 hour. On (b)(6) 2018 a call was placed to the pt and additional information was provided: the pt went to the eye care provider (ecp) on (b)(6) 2018 and advised the corneal ulcer has not resolved. The ecp prescribed norfloxacin eye drops every 2 hours. The pt was also advised to apply sodium hyaluronate eye drop as needed for discomfort. The medical report was requested. On (b)(4) 2019 a call was placed to the pt who refused to provide the medical report. No additional medical information has been received. The event date is reported as (b)(6) 2018. The os suspect contact lens was discarded. 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 5636560104 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. ¿ IRELAND
one technological park plassey
limerick
EI
Manufacturer Contact
rose harrell
7500 centurion parkway
jacksonville, FL 32256
9044433364
MDR Report Key8245621
MDR Text Key132987479
Report Number9617710-2019-00001
Device Sequence Number1
Product Code LPL
Combination Product (y/n)Y
Reporter Country CodeCH
PMA/PMN Number
K042275
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberTSP
Device Lot Number5636560104
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/26/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/14/2019 Patient Sequence Number: 1
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