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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE - IRELAND ACUVUE OASYS®1 DAY WITH HYDRALUXE¿ TECHNOLOGY LENSES, SOFT CONTACT, DAILY WEAR

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JOHNSON & JOHNSON VISION CARE - IRELAND ACUVUE OASYS®1 DAY WITH HYDRALUXE¿ TECHNOLOGY LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Catalog Number TSP
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bacterial Infection (1735)
Event Date 11/01/2021
Event Type  Injury  
Event Description
On (b)(6) 2021 an eye care provider (ecp) in (b)(6) called to report a patient (pt) had an ¿eye infection¿ in the os while wearing the acuvue® oasys 1-day with hydraluxe® brand contact lens (cls). The event occurred ¿sometime this week¿, (b)(6) 2021. The pt went to a doctor who prescribed an unknown ¿antibacterial eye drop. ¿ the ecp ¿thinks¿ the pt had a ¿bacterial eye infection¿ but can¿t be sure. The pts os is currently fine. No additional medical information was provided. On (b)(6) 2021 a call was placed to the pts reporting ecp who advised the pt does not wish to be contacted. The ecp will call the pt to see if the pt will provide any additional medical information. No additional medical information is known. This event is being reported as a worst-case event as we were unable to verify the pts diagnosis and treatment. 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 6311720101 was produced under normal conditions. The suspect os cls was discarded. No additional evaluation can be conducted. If any further relevant information is received, a supplemental report will be filed.
 
Manufacturer Narrative
Suspect product discarded.
 
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Brand NameACUVUE OASYS®1 DAY WITH HYDRALUXE¿ TECHNOLOGY
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
JOHNSON & JOHNSON VISION CARE - IRELAND
1 technological park plassey
limerick LK130 01
EI LK13001
Manufacturer Contact
helene aguilar
7500 centurion parkway
jacksonville, FL 32256
9044433835
MDR Report Key13014080
MDR Text Key287697840
Report Number1057985-2021-00176
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeSN
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 12/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberTSP
Device Lot Number6311720101
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/28/2018
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: 12/15/2021 Patient Sequence Number: 1
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