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 Ulcer (1796); Unspecified Infection (1930); Neovascularization (1978); Pain (1994); Loss of Vision (2139)

Event Date 02/20/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Unable to confirm complaint; device not returned.

Event Description

On 09apr2018 during a routine maude database search, a health care professional reported that a ¿patient (pt) had been buying ¿colored contacts¿ without a prescription and sleeping in them for years.The pt came to my office with pain in the eyes.The pt had massive amounts of neovascularization in both corneas completely covering the pt's central vision.The pt also had a beginning ulcer.The pt's immediate infection was treated, but the pt was lost to f/u.The pt will most likely have resulting vision loss and will never be able to wear contacts again due to the damage.¿ no contact information was provided.No additional information is expected.The event date is reported as (b)(6) 2018.The mw report number is: mw5075734.It is unknown which eye had the ¿beginning ulcer¿.It was not reported which acuvue brand contact lens the pt was wearing at the time of the event.No lot number was provided and it is unknown if the suspect product is available.This report is for the pts os event.The pts od event will be submitted in a separate report.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: 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
• MDR Report Key: 7481409
• MDR Text Key: 107190179
• Report Number: 1057985-2018-00070
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability