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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Irritation (1941); Pain (1994); Excessive Tear Production (2235); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

On (b)(6) 2019, a patient (pt) from (b)(6) reported irritation and discomfort in the left eye (os) while wearing 1-day acuvue® trueye® (nara a) brand contact lenses (cl). The pt continued to wear the cls for a week and experienced an increase in pin-pricking pain, irritation, and tearing in the os after removal of the suspect cl. The pt sought medical attention on (b)(6) 2019 and was diagnosed with bacterial eye infection os. The pt was instructed to discontinue cl wear for 3 days and return for follow-up (fu). The pt was prescribed levofloxacin ophthalmic solution (unspecified dosage and frequency). On (b)(6) 2019, the pt returned for fu, and the eye care provider (ecp) found no issue with the os. No further treatment or fu was instructed. The pt currently has no problems with the os and has resumed cl wear in a different brand of cls. Event date is (b)(6) 2019. On (b)(6) 2019, additional information was received from the pt: the pt was prescribed levofloxacin ophthalmic solution 1. 5%, 5 times per day. On (b)(6) 2019, additional information was received from the treating ecp: the pt was seen on (b)(6) 2019 complaining of pain os. The pt was diagnosed with a corneal infection os, which the ecp considered infectious. The ecp prescribed antibiotic drops; culture was not conducted; focal site location: inferior part, outward from the center; size was not measured, but approximately 1 mm; pt was instructed to discontinue cl wear and return for fu. Pt returned for fu on (b)(6) 2019. Recovery not confirmed. The pt was allowed to return to cls wear on (b)(6) 2019 with no return of symptoms; no scarring noted. No additional information has been received. The suspect os 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 5836300106 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, INC. ¿ IRELAND; one technological park plassey; limerick ; EI
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 8441639
• MDR Text Key: 139540714
• Report Number: 9617710-2019-00005
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): Y
• 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,health profe

Reporter Occupation

• Type of Report: Initial
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 1D4
• Device Lot Number: 5836300106
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2018
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 03/21/2019 Patient Sequence Number: 1