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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Irritation (1941); Uveitis (2122); Discharge (2225); Excessive Tear Production (2235)

Event Type  Injury  

Manufacturer Narrative

Eval: device not returned; no findings available; no problem detected; adverse event without identified device or use problem.

Event Description

On 26jun2018 an email was received from a patient (pt) who reported about two months ago both eyes became very irritated and ¿infected¿ while wearing the 1-day acuvue define with lacreon brand contact lenses.Pt reported pt ¿had to 6 weeks off of contacts entirely¿.On 10jul2018 a call was placed to the pt and additional information was provided: pt was diagnosed with uveitis ou 2 months ago ((b)(6) 2018) while wearing the suspect 1-day acuvue define with lacreon brand contact lenses.Pt reported light sensitivity, irritation, tearing, discharge ou and went to an eye care provider (ecp).Pt was advised to discontinue contact lens wear and prescribed a steroid eye drop tid and liquid tears.Pt advised the event resolved and was cleared to return to contact lens wear.The pt was given trial lenses in acuvue oasys brand contact lenses.Pt is interested in finding a daily wear colored lens.Pt reported both eyes are currently fine.At the time of the call the pt didn¿t have the treating ecp contact information for additional information.On 01aug2018 an email was received from the pt with additional information: the pt provided the name of an ecp, but no contact information.The pt reported a possible return visit to the ecp provided.An internet phone search was conducted for the ecp contact telephone number.A call was placed to the ecp¿s office, but it was disconnected.Correct ecp contact information was requested from the pt, but nothing additional has been received.This report is being submitted for the pt¿s os as a worst-case event as the diagnosis and treatment were unable to be verified by the treating ecp.The report for the pts od will be filed in a separate report.The lot is unknown, and the suspect lens was discarded.If any further relevant information is received, a supplemental report will be filed.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: 7757606
• MDR Text Key: 116257518
• Report Number: 1057985-2018-00098
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: N18033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2018
• 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
• Date Manufacturer Received: 07/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention