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 Irritation (1941); Keratitis (1944); Pain (1994); Red Eye(s) (2038)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2018, a patient (pt) from (b)(6) wearing 1-day acuvue trueye contact lenses (cls) reported that in (b)(6) 2018 the pt experienced irritation, redness, and pain after removal of the cl and visited an eye care professional (ecp).The pt was diagnosed with keratitis in the left eye (os).The pt was prescribed antibacterial eye drops (unspecified name, dosage, duration) and was instructed to discontinue cl wear for two weeks.The pt¿s os is currently recovered.The suspect product was discarded.On (b)(6) 2018, the pt was contacted and reported that the eye drops that were prescribed were gatiflo eye drops 0.3% (gatifloxacin hydrate), to be applied every 2-3 hours for the first 3 days until the follow-up visit and then tid.The pt revisited the clinic after a week from the follow-up visit and was diagnosed with recovery and was instructed to discontinue the gatiflo eye drops.Additional information is not available as the patient refused consent to contact the treating ecp.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 5829210105 was produced under normal conditions.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 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: 7527240
• MDR Text Key: 108728167
• Report Number: 9617710-2018-05034
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K073485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/23/2018

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: 5829210105
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/23/2018
• Initial Date FDA Received: 05/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention