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 Bacterial Infection (1735); Irritation (1941); Keratitis (1944); Neovascularization (1978); Red Eye(s) (2038)

Event Date 03/13/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On 03apr2017 an eye care provider (ecp) called our affiliate in the (b)(6) to report that the patient (pt) ¿had a serious eye infection on his/her eyes¿ while wearing the 1-day acuvue trueye brand contact lenses. It was reported that the ecp is the pts parent. The ecp reported that the pt called approximately three weeks ago and complained of a ¿white spot on his/her eye, but reported no pain or other symptom. ¿ the ecp advised the pt to go to an ophthalmologist, who gave eye drops. The pts eye felt gritty after eye drops were put in and reported that the pts ¿eye turned pink. ¿ the pt is still using eye drop today. On 10apr2017 a return call was placed to the ecp (pts parent) in the (b)(6) by a johnson and johnson professional affairs physician and the additional information was provided: the right eye is the affected eye; two lesions approximately 0. 8 mm in size at 11 o¿clock; no anterior chamber reaction; symptoms: photophobia and redness, initially mild but escalating to significant over two hours; va prior to event 6/6; current va not known (review appointment scheduled (b)(6) 2017; ophthalmology report: 1. Contact lens related keratitis; paraxial superior sub-epithelial corneal fibrosis; myopic astigmatism; corneal micropannus. Treatment: ofloxacin initially every hour, chloramphenicol 1% bes; prednisolone 0. 5 % preservative free for two weeks; treatment suggests this was a moderate case of bacterial keratitis. On 17apr2017 an email was received from the affiliate in the (b)(6) that no corneal scrapes were taken. The event date is reported as (b)(6) 2017. A follow-up appointment is scheduled for (b)(6) 2017. The pt is still receiving ongoing treatment with prednisolone drops. Additional medical information was requested. The product was requested for return, but it has not yet been received. 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 5512010110 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.

Manufacturer Narrative

Additional medical information was received from the affiliate in the united kingdom on 14may2017: the pt is reported as doing well and is continuing the steroid drops. On 16may2017 additional information was received as follows: the va is reported as 6/7. 5 (0. 1 logmar) since the last appointment. No additional information was received; no additional information is expected. 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 park blvd.; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 6523091
• MDR Text Key: 73763025
• Report Number: 9617710-2017-05002
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K073485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 06/01/2018
• Device Catalogue Number: 1D4
• Device Lot Number: 5512010110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2014
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 04/26/2017 Patient Sequence Number: 1