MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND 1-DAY ACUVUE TRUEYE (NARA A); LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number 1D4

Device Problem No Apparent Adverse Event (3189)

Patient Problems Corneal Ulcer (1796); Irritation (1941)

Event Date 03/24/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2018, an eye care professional (ecp) in spain who reported a (patient) pt experienced torn lenses and eye irritation on (b)(6) 2018 while wearing 1-day acuvue trueye contact lenses (cls).The ecp reported the pt presented to the hospital, however, the diagnosis and treatment was unknown.On (b)(6) 2018 the ecp was contacted and provided the following information: ecp reported the pt was diagnosed with a ¿small¿ corneal ulcer on the right eye (od) and was prescribed eye drops (unspecified name, dosage, and duration).On (b)(6) 2018 the ecp was contacted and provided the following information: ecp reported that the ulcer had resolved and the pt¿s eye was fully recovered.The pt was instructed to discontinue cl wear for 2-3 weeks and the pt is currently wearing glasses.Multiple attempts were made for additional information.Additional information is not expected.The suspect cl is not available, as it was discarded.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 5631820101 was produced under normal conditions.If additional information is received, will report within 30 days of receipt.Serious reportable event trends are reviewed quarterly in franchise management review meetings.

• Brand Name: 1-DAY ACUVUE TRUEYE (NARA A)
• 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: 7469037
• MDR Text Key: 106760985
• Report Number: 9617710-2018-05030
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K073485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/11/2018

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: 09/01/2022
• Device Catalogue Number: 1D4
• Device Lot Number: 5631820101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2018
• Initial Date FDA Received: 04/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention