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U.S. Department of Health and Human Services

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

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JOHNSON & JOHNSON VISION CARE, INC. - US 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 Neovascularization (1978)
Event Date 02/02/2022
Event Type  Injury  
Manufacturer Narrative
Suspect product availability unknown.
 
Event Description
On (b)(6) 2022 a representative of johnson and johnson vision care received notification from an eye care professional (ecp) in the united kingdom that a patient (pt) required hospital treatment for severe neovascularization while wearing acuvue oasys® 1-day contact lenses with hydraluxe¿ technology contact lenses (cls). On (b)(6) 2022, the johnson and johnson representative advised that the ecp refused to provide any additional information regarding the pt¿s event. The ecp also refused to provide the pt¿s contact information as the pt didn¿t want to be contacted. The ecp reported ¿the incident is not necessarily due to the cls themselves. No additional medical information was provided. The date of the event is unknown, therefore the received date of the complaint ((b)(6) 2022) will be used as the date of event. It is unknown which eye(s) was affected. The suspect lot number was not provided. No additional investigation can be conducted. This event will be submitted as a worst-case event as we were unable to verify the pt¿s diagnosis and treatment. It is unknown if the suspect contact lens(es) are available for return for evaluation. If any further relevant information is received, a supplemental report will be filed.
 
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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, INC. - US
7500 centurion parkway
jacksonville FL 32256
Manufacturer Contact
helene aguilar
7500 centurion parkway
jacksonville, FL 32256
9044433835
MDR Report Key13606261
MDR Text Key287668115
Report Number1057985-2022-00015
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K042275
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 02/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberTSP
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/02/2022
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? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/25/2022 Patient Sequence Number: 1
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