MAUDE Adverse Event Report: JANSSEN PHARMACEUTICA N.V. VISINE FOR CONTACTS (US); NONE

Lot Number DKB3P01

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Red Eye(s) (2038)

Event Type  Injury  

Event Description

This spontaneous report was received from a (b)(6)-year-old female pt reporting on herself from the us: (b)(6).The pt's height was not reported and weight was (b)(6) pounds.The pt's med history included: anxiety, chronic pain, depression, jaw bone pain, latex allergy, smoking and wisdom teeth removal.The pt was treated with visine for contacts (us) (drops, opthalmic (eye), batch (b)(4), expiry 20-oct-2015) at least once or twice a day, 4 to 5 days initiated on an unspecified to moisten the eyes.Concomitant medications included ibuprofen and oxycodone for jaw bone pain, escitalopram oxalate for depression and clonazepam for anxiety.The pt bought the product about 2 and a half weeks ago.She used it to keep her eyes moist because she wears contacts.The pt applied the product at least once or twice a day, 4 to 5 days in a row.On (b)(6) 2014, her right eye turned completely red had taken her contacts out that night and then went to sleep.The next morning, (b)(6) 2014, when she woke up, her other eye was completely red.She thought again it was her contacts.She took them out and wore her glasses; she had started to get a film in her eyes (film on eyes) with green mucus (mucus in eyes).She didn't understand because she wasn't around anyone who was sick.She thought she would wait a day before she put her contacts in.The following day, her eyes were matted shut.She went to her eye doctor and the doctor asked her if she was using anything else besides her contact solution.The doctor told her that she didn't have pink eye, but that she had some kind of bacteria in her eyes (eye infection bacterial nos).The doctor prescribed her two different kinds of eye drops to use 4 times a day.She had to throw her contacts away along with the case they were in and to stop using the product (visine).The pt was recovering from eye infection bacterial nos, eyes turned red and film on eyes and had recovered from mucus in eyes on an unspecified date.This report was associated with a product qual complaint.This report was serious (medically significant).This case is linked to drug/device case (b)(4).

• Brand Name: VISINE FOR CONTACTS (US)
• Type of Device: NONE
• Manufacturer (Section D): JANSSEN PHARMACEUTICA N.V.; beerse 2340
• Manufacturer Contact: 199 grandview rd; skillman, NJ 08558 ; 6108505961
• MDR Report Key: 4092410
• MDR Text Key: 16557053
• Report Number: 2246407-2014-00700
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Type of Report: Initial
• Report Date: 08/15/2014

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/20/2015
• Device Lot Number: DKB3P01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/15/2014
• Initial Date FDA Received: 09/04/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CLONAPIN (CLONAZEPAM), 0.5 MG, 2 IN 1 DAY; IBUPROFEN, 800 MG, 2 IN 1 DAY; OXYCODONE, 5MG; LEXAPRO (ESCITALOPRAM OXALATE), 20 MG, 2 IN 1 DAY
• Patient Outcome(s): Other
• Patient Age: 29 YR
• Patient Weight: 54