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

Catalog Number 1D4

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Corneal Ulcer (1796); Corneal Clouding/Hazing (1878); Pain (1994)

Event Date 09/13/2019

Event Type  Injury  

Event Description

On (b)(6) 2019, a call was placed to the pt who reported that on (b)(6) 2019, the pt experienced pain in the right eye (od).The pt called the treating eye care provider (ecp) from a previous corneal ulcer event for od (reported in mdr # 9617710-2019-00033 on (b)(6) 2019), and the treating ecp advised the pt to resume the same previously prescribed treatment and discontinue cl wear until the issue resolves.The pt was previously prescribed ofloxacin every 2 hours for the first day, then 4 times a day for 7 days.The pt is currently on the third day of treatment and reported that the od is better.The pt noted no longer experiencing any pain.The pt does not have any follow-up appointment scheduled.The pt reports a daily wear schedule and does not sleep in cls or use any solution to clean cls.No further information was provided.On (b)(6) 2019, a call was placed to the treating ecp and additional information was provided: visit on (b)(6) 2019: the pt was diagnosed with central corneal ulcer at inferior nasal to visual axis; corneal ulcer was on the od and roughly the same spot as the previous corneal ulcer; pt was treated with 0.3% ofloxacin q2h for the first day then qid for 1 week.The ecp noticed some haze but thinks it will clear over time.The pt does not have a follow-up appointment scheduled.No further information was provided.No additional information has been received.The suspect od 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 5358090102 was produced under normal conditions.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: 1-DAY ACUVUE TRUEYE (NARA A)
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE ¿ IRELAND; one technological park plassey; limerick ; EI
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 9175293
• MDR Text Key: 173187712
• Report Number: 9617710-2019-00034
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K073485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2023
• Device Catalogue Number: 1D4
• Device Lot Number: 5358090102
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 34 YR