MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION - IRELAND 1-DAY ACUVUE® DEFINE¿ WITH LACREON®; LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number 1DL

Device Problem No Apparent Adverse Event (3189)

Patient Problem Corneal Ulcer (1796)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2017 our affiliate in (b)(6) received a complaint from an eye care provider (ecp) who reported a patient (pt) was diagnosed with a corneal ulcer while wearing a 1-day acuvue define with lacreon brand contact lens.Per the affiliate, it was requested no further contact with the patient (pt) or ecp be attempted for follow-up medical and product information.No additional medical information is available.The lot number and the product availability were not provided.The date of event was not reported and it is unknown which was the affected eye.This event is being reported as a worst-case event as the diagnosis and treatment were unable to be verified by the 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: 1-DAY ACUVUE® DEFINE¿ WITH LACREON®
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION - IRELAND; one technological park plassey; limerick ; EI
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 6900555
• MDR Text Key: 87631454
• Report Number: 9617710-2017-05046
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: KN
• PMA/PMN Number: N18033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/06/2017

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: 1DL
• Device Lot Number: UNK-1DL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2017
• Initial Date FDA Received: 09/28/2017
• 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