MAUDE Adverse Event Report: JOHNSON AND JOHNSON ACUVUE OASYS

Device Problem Contamination (1120)

Patient Problems Bacterial Infection (1735); Corneal Ulcer (1796)

Event Date 06/28/2017

Event Type  Injury  

Event Description

Patient wearing contact lenses overnight and using tap water to re-wet lenses before putting them in.Developed severe sight/eye threatening bacterial corneal ulcer which is still undergoing treatment.Will probably need tectonic corneal graft and has already been cultured and glued twice.

• Brand Name: ACUVUE OASYS
• Type of Device: ACUVUE OASYS
• Manufacturer (Section D): JOHNSON AND JOHNSON
• MDR Report Key: 6724627
• MDR Text Key: 80534824
• Report Number: MW5071085
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/17/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 63 YR