MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND 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 Inflammation (1932); Keratitis (1944); Pain (1994); Red Eye(s) (2038); Discomfort (2330)

Event Date 11/29/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2018, an eye care provider (ecp) from (b)(6) reported that the patient (pt) had inflammation after wearing 1-day acuvue® define¿ with lacreon® brand contact lenses (cl).The pt reported left eye (os) pain and redness while wearing the cl on (b)(6) 2018.The pt¿s os was still red after the suspect cl was removed.The pt visited an ecp who diagnosed keratitis os and was prescribed anti-inflammatory eyedrop once every 2 hours; artificial tear eyedrops to apply whenever the pt feels discomfort; eye ointment once before sleep (unspecified names of medications).The pt was informed by the ecp that this was considered aggressive treatment.The pt reported a follow-up visit ¿after several days.¿ the pt noted that the os is currently better.On (b)(4) 2018, additional information was received from the pt: the pt reported that the name of the eye drops was "sodium hyaluronate eye drops" and "ofloxacin eye drops" (once every 2 hours).The pt was unable to provide the name of the eye ointment.Pt was willing to send the medical report.On (b)(6) 2018, a prescription receipt was received with the following additional information: prescription: ofloxacin eye ointment, 2 times a day; sodium hyaluronate eye drops, 3 times a day; levofloxacin eye drops, every 2 hours.Multiple attempts were made to the pt to obtain the medical report, but nothing additional has been received.The suspect cl is not available for return.A lot history review was performed and revealed the following: the batch record did not show any abnormalities in monomer and solution testing.All parameters tested were within specification.All sterilization requirements were successfully completed.Lot 2344330103 was produced under normal conditions.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: 1-DAY ACUVUE DEFINE WITH LACREON
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND; one technological park plassey; limerick ; EI
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 8196765
• MDR Text Key: 131483376
• Report Number: 9617710-2018-05073
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: N18033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/03/2018

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 Expiration Date: 01/01/2023
• Device Catalogue Number: 1DL
• Device Lot Number: 2344330103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 12/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention