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

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.

• Brand Name: ACUVUE OASYS®1 DAY WITH HYDRALUXE¿ TECHNOLOGY
• Type of Device: LENSES, 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 Key: 13606261
• MDR Text Key: 287668115
• Report Number: 1057985-2022-00015
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K042275
• Number of Events Reported: 1
• 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 Received: 02/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: TSP
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2022
• 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