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

Catalog Number 1D4

Device Problem No Apparent Adverse Event (3189)

Patient Problem Corneal Ulcer (1796)

Event Date 11/06/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2018 a johnson and johnson sales representative in (b)(6) reported that a patient (pt) presented to an eye care provider (ecp) and was diagnosed with a corneal ulcer in the right eye while wearing the 1-day acuvue trueye brand contact lenses on (b)(6) 2017.The pt was prescribed flumetholon ophthalmic suspension 0.1%, cravit ophthalmic solution 1.5%.The pt returned for follow-up visits on (b)(6) 2017 and (b)(6) 2017.The pt received cefamezin 2g for infusion kit intravenously and the symptom healed with scar formation.The right eye is fine currently.On (b)(6) 2018 an email was sent to the johnson and johnson sales representative and requested additional a medical interview with the pts treating ecp.On (b)(6) 2018 additional information was received: the johnson and johnson sales representative will conduct a medical interview in the week on (b)(6) 2018.On (b)(6) 2018 an email was received from the sales representative and additional information was provided: on (b)(6) 2018 a medical interview was conducted with the eye clinic representative.The pt was diagnosed with 2 corneal ulcers od; ¿focal site: peripheral, at 3 o¿clock and 6 o¿clock.Size: not measured, about 0.5 mm x 0.5 mm each; infectiveness: none; the symptom was va affected.Va od was originally 1.2 (20/16).On (b)(6) 2018, va od was 0.6 (20/32), on (b)(6) va od was 0.9 (20/20); treatment: on (b)(6) 2017, flumetholon ophthalmic suspension qid, cravit ophthalmic solution 1.5% qid, keflex oral medicine 4 tablets / day¿.Follow-up visits on (b)(6) 2017; cefamezin 2g for infusion kit, flumetholon ophthalmic suspension qid, cravit ophthalmic solution 1.5% qid, keflex oral medicine 4 tablets/day; instructions to discontinue contact lens wear for 7 days from (b)(6) 2017; ¿the pt¿s last consultation date was (b)(6) 2017; seriousness: not serious; outcome: resolved.The symptom healed with scar formation¿.On (b)(6) 2018 the sales representative visited the clinic and the ecp reported the doctor adopts antibiotic injection therapy to hasten resolution.No additional medical information was provided.No additional medical information has been received, no additional medical information is expected.The lot number is unknown and the suspect lens was discarded.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

On 12mar2018 during a file review it was noted that there was a date error on the initial mdr.Continued on page 3 - "(b)(6) 2018" should be (b)(6) 2017.It was also incorrectly noted that the product was not labeled for single use.The product is labeled for single use.

• Brand Name: 1-DAY ACUVUE TRUEYE (NARA A)
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. ¿ US; 7500 centurion parkway; jacksonville FL
• MDR Report Key: 7321396
• MDR Text Key: 101781316
• Report Number: 1057985-2018-00025
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• PMA/PMN Number: K073485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/12/2018

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 Catalogue Number: 1D4
• Device Lot Number: UNK-1D4
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/06/2018
• Initial Date FDA Received: 03/07/2018
• Supplement Dates Manufacturer Received: 03/12/2018
• Supplement Dates FDA Received: 03/16/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention