MAUDE Adverse Event Report: HOOD CONTAINER CORPORATION AIR OPTIX NIGHT AND DAY JOHNSON AND JOHNSON; LENSES, SOFT CONTACT, EXTENDED WEAR

Patient Problem Eye Infections (4466)

Event Date 03/14/2024

Event Type  Injury  

Event Description

Pseudomonas corneal infection after sleeping in air optix night and day lens.Reference report: mw5153279.

• Brand Name: AIR OPTIX NIGHT AND DAY JOHNSON AND JOHNSON
• Type of Device: LENSES, SOFT CONTACT, EXTENDED WEAR
• Manufacturer (Section D): HOOD CONTAINER CORPORATION
• MDR Report Key: 18990000
• MDR Text Key: 338936210
• Report Number: MW5153278
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 90 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White