MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ US UNK-SOFT CONTACT LENSES

Catalog Number UNK-SOFT CONTACT LENSES

Device Problem No Apparent Adverse Event (3189)

Patient Problems Corneal Scar (1793); Corneal Ulcer (1796); Fungal Infection (2419)

Event Type  Injury  

Event Description

On (b)(6) 2018, while speaking with a patient (pt) about a current event, medical documentation that the pt provided revealed a corneal ulcer, possible ¿fungal¿ infection in the od.Medical records from eye care provider (ecp) visit on (b)(6) 2017: additional comments: ¿in the past (10 years ago) i had a fungal infection od due to my contact lens solution.Had daily scraping at pts ecp office¿.Slit lamp exam: od corneal scar superiorly 3 mm irregular shape, minimal thinning and edema within stroma tr centrally.Od severity of corneal scar/opacity: moderate.It was noted that pt has a ¿history of severe corneal ulcer od (? fungal) - no evidence of infection at that time¿.A call was placed to the pt requesting additional information.On (b)(6) 2018, the pt was contacted and stated that the event happened 14-15 years ago when a ¿solution scare occurred¿.The pt was unable to provide the name of the treating ecp, but stated the ecp at that time would try to ¿save¿ the eye.The pt was unsure if acuvue brand lenses were being worn at the time of the event.On (b)(6) 2018, the pt was contacted and stated that the ¿infection was due to the solution that was not related to lenses¿.No additional information was provided.No additional information was received.This od event is being submitted as a worst-case event as it is unknown what contact lens brand the pt wore at the time of the event.If additional information is received, will report within 30 days of receipt.(b)(4).

• Brand Name: UNK-SOFT CONTACT LENSES
• Type of Device: UNK-SOFT CONTACT LENSES
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. ¿ US; 7500 centurion parkway; jacksonville FL
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 7523603
• MDR Text Key: 108610086
• Report Number: 1057985-2018-00072
• 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: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/23/2018

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: Lay User/Patient
• Device Catalogue Number: UNK-SOFT CONTACT LENSES
• Device Lot Number: UNK-UNK-SOFT CONTACT LENSES
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/23/2018
• Initial Date FDA Received: 05/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention