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 Problems Bacterial Infection (1735); Corneal Ulcer (1796); Pain (1994); Red Eye(s) (2038); Swelling (2091)

Event Date 06/16/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On 15aug2017 a patient (pt) called our affiliate in (b)(4) to report right eye pain, redness, and swelling while wearing the 1-day acuvue trueye brand contact lens on (b)(6) 2017.The pt reported he/she went to an eye care provider (ecp) who diagnosed ¿a part of the pts right corneal was peeled off, which might be caused by bacteria¿.The pt was instructed to discontinue contact lens wear for six weeks.The pt reported follow-up visits to the ecp the next day, day three, and a week after the first visit per ecp instructions.The pt reported after a week the right eye was better.The pt returned to contact lens wear, but the date of return to wear was unknown.The pt reported he/she has continued follow-up visits to the ecp to check the condition of the right eye after the return to lens wear.The doctor prescribed eye drops of levofloxacin 1.5%, fluorometholone, and tobramycin 0.3%, with ophthalmic ointment (erythromycin lactobionate, colistin sodium methanesulfonate).The pt was instructed to apply the eye drops and the ointment once every hour at the first visit.The pt reported the right eye is fine currently.On 17aug2017 a face to face meeting with the pts treating ecp was requested.On 01sep2017 the pts ecp sent an email and provided the additional information as follows: diagnosis: - focal site: - size: - infectiveness: (y: staphylococcus); seriousness: serious (basis: pain); influence to visual acuity: none; outcome: recovered; dates of pt¿s visit: 7 visits and pt has a return appointment; treatment/medication for the pt: antibiotic on 01sep2017 a medical interview with the pts treating ecp was scheduled for (b)(6) 2017.On 07sep2017 the affiliate in (b)(4) had a face to face medical interview with the pts treating ecp and the additional medical information was provided: the pt presented to the ecp on (b)(6) 2017; pt was diagnosed with corneal ulcer od; pt was using the cl with compliance; infectiveness: yes; culture: yes (coagulase negative staphylococci that was detected from corneal scraping; focal site and size: located at 11 o¿clock in upper cornea, size 1 millimeter, off pupil; va affect: na; treatment: levofloxacin eye drops 1.5%, tobramycin eye drops 0.3%, and erythromycin lactobionate eye ointment q1h; instruction to discontinue the cl wear: instructed until the symptom resolved; instruction to return to clinic: on (b)(6) 2017.On (b)(6) 2017, pt returned to clinic: outcome: resolving.On (b)(6) 2017, pt returned to clinic: outcome: resolving; on (b)(6) 2017, pt returned to clinic: outcome: resolving; treatment: fluorometholone eye drops 0.1% was additionally prescribed as opacity remained in affected area.On (b)(6) 2017, pt returned to clinic: outcome: resolved.No visit since then.No additional medical information was obtained; no additional medical information is expected.The lot number is unknown and the suspect product 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.

• 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
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 6851635
• MDR Text Key: 85305741
• Report Number: 1057985-2017-00109
• 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,health profe
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/15/2017

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: 08/15/2017
• Initial Date FDA Received: 09/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention