MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ US 1-DAY ACUVUE DEFINE WITH LACREON; LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number 1DL

Device Problem No Apparent Adverse Event (3189)

Patient Problems Irritation (1941); Pain (1994); Red Eye(s) (2038)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2017, our affiliate in (b)(6) received a call from a patient (pt) who reported experiencing eye pain and redness while wearing 1 day acuvue define with lacreon contact lenses.Pt reported the eye was red for about 2 days.Pt reported the lot number for the product in question was discarded, however, the pt reported the product in question was available for return.Pt reported he/she will present to a doctor and call back.Pt reported the event occurred in (b)(6) 2017.0n (b)(6) 2017, pt called to report he/she presented to an eye care provider (ecp) and would provide the medical receipts.Pt declined to provide a copy of the doctor¿s medical report.Pt reported experiencing an ¿eye wound¿ with eye irritation and eye redness.Pt reported being prescribed loteprednol etabonate and levofloxacin eye drop every 2 hours.Pt reported the left eye was affected.The lot number is unknown.No suspect product is available.No additional medical information has been received.No additional information is expected.This os event is being reported as a worst case as the ¿eye wound¿ diagnosis and treatment were unable to be verified by 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: 1-DAY ACUVUE DEFINE WITH LACREON
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• 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: 6835554
• MDR Text Key: 84272766
• Report Number: 1057985-2017-00101
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: N18033
• 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: 08/09/2017

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
• Initial Date Manufacturer Received: 08/09/2017
• Initial Date FDA Received: 08/31/2017
• 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