MAUDE Adverse Event Report: JOHNSON AND JOHNSON VISION - US UNK-SOFT CONTACT LENSES

Catalog Number UNK-SOFT CONTACT LENSES

Device Problem No Apparent Adverse Event (3189)

Patient Problems Unspecified Infection (1930); Red Eye(s) (2038)

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

On (b)(6) 2017 a patient (pt) from (b)(6) called to report a current issue with an acuvue brand contact lens.In a follow-up call placed to the pt on 08nov2017, the pt reported he/she was advised by an eye care provider (ecp) he/she had a ¿severe eye infection¿ caused by a ¿fungus¿ on the lens and almost lost vision in the right eye while wearing an unknown acuvue brand contact lens.The pt reported the lenses were astigmatism lenses.Pt reported the event date was eighteen years ago (1999).The pt reported the ecp did not perform any cultures on the right eye or on the suspect lens.The pt reported the right eye was red, no other symptoms reported.The pt was prescribed eye drops (name of the eye drop and how many times per day it was prescribed were unknown) and the treatment was for fifteen days.The pt reported he/she was advised to discontinue contact lens wear for six months.Pt reported the right eye was better in fifteen to twenty days.Pt reported he/she went to a different ecp after the six months and was informed the pt ¿probably didn¿t need to stop wearing lenses for six months and according to the symptoms it was not a severe issue, and the pts eyes were healthy¿.Pt could not recall his/her contact lens replacement schedule and reported ¿it was prolonged wear, probably about nine to twelve months¿.The pt could not recall the treating ecps name or contact information.No additional medical information has been received.No additional medical information is expected.The lot number is unknown and the suspect product is not available for return.This event is being submitted as a worst-case event as the diagnosis and treatment were unable to be verified with the pts treating ecp.If additional information is received it will be reported within 30 days of receipt.Serious reportable event trends are reviewed quarterly in franchise management review meetings.

• Brand Name: UNK-SOFT CONTACT LENSES
• Type of Device: SOFT CONTACT LENSES
• Manufacturer (Section D): JOHNSON AND JOHNSON VISION - US; 7500 centurion parkway; jacksonville FL
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 7072850
• MDR Text Key: 93429783
• Report Number: 1057985-2017-00136
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/08/2017

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: 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: 11/08/2017
• Initial Date FDA Received: 11/30/2017
• 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