MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. - US ACUVUE® OASYS®; LENSES, SOFT CONTACT, EXTENDED WEAR

Catalog Number PH

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Eye Injury (1845); Blurred Vision (2137); Loss of Vision (2139)

Event Date 06/12/2023

Event Type  Injury  

Event Description

On (b)(6) 2024, an email was received from the johnson and johnson legal department who reported receipt of a letter from a patient¿s (pt) legal representative advising a pt experienced right eye (od) vision loss while wearing an acuvue® oasys® brand contact lens (cl).On (b)(6) 2023, the pt experienced ¿severe damage¿ to the od, beginning with blurred vision, a cut to the cornea, then loss of od vision.The pt is scheduled for a cornea replacement in (b)(6) 2024.No additional medical or product information has been received.The suspect lot number was not provided.It is unknown if the suspect od cl is available for return for evaluation.No additional evaluation can be conducted.If any further relevant information is received, a supplemental report will be filed if applicable.

Manufacturer Narrative

H3 other text : suspect product availability is unknown.

• Brand Name: ACUVUE® OASYS®
• Type of Device: LENSES, SOFT CONTACT, EXTENDED 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 ; 9047429918
• MDR Report Key: 18816844
• MDR Text Key: 336741156
• Report Number: 1057985-2024-00007
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: PH
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/06/2024
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other; Disability