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 02/05/2018

Event Type  Injury  

Event Description

On (b)(6) 2018 a johnson and johnson sales representative in (b)(4) reported that a patient (pt) was diagnosed with a corneal ulcer in the left eye on (b)(6) 2018 while wearing the 1-day acuvue trueye brand contact lens.The pt went to an eye care provider (ecp) and was prescribed flumetholon ophthalmic suspension 0.1%, cravit ophthalmic solution 1.5%, and tarivid eye ointment.On (b)(6) 2018, the pt received cefamezin 2g for infusion kit intravenously.The pt was instructed to return for follow-up visit on (b)(6) 2018.A medical interview was requested.On 07feb2018 and email was received from the johnson and johnson sales representative with additional information: the sales representative will visit the clinic for medical interview next week.On 08feb2018 the sales representative will conduct a medical interview on (b)(6) 2018.On (b)(6) 2018 the sales representative visited the eye clinic for a medical interview.The clinic representative reported the diagnosis was corneal ulcer os; focal site: peripheral, at half past five.Size: not measured, about 0.5 mm x 0.5 mm; infectiveness: nor recorded; the ecp did not measure va after (b)(6) 2018.On (b)(6) 2018, va os was 1.0; treatment: (b)(6) 2018, cefamezin 2g for infusion kit, flumetholon ophthalmic suspension 0.1% qid, cravit ophthalmic solution 1.5% qid, keflex oral medicine 4 tablets/day, tarivid eye ointment.On (b)(6) 2018 follow-up appointment: cefamezin 2g for infusion kit, bestron for ophthalmic qid, cravit ophthalmic solution 1.5% qid, keflex oral medicine 4 tablets / day, tarivid eye ointment.No contact lens wear continuing from (b)(6) 2018; pt instructed to return for follow-up visit on (b)(6) 2018; seriousness: not serious; outcome: improved; follow-up visit on (b)(6) 2018.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.On 14feb2018 an email was received from the sales representative who provided additional information: a correction was made to the medication prescribed on (b)(6) 2018: pt was prescribed cefamezin 2g for infusion kit, cravit ophthalmic solution 1.5% qid, keflex oral medicine 4 tablets / day, tarivid eye ointment and bestron for ophthalmic qid.On (b)(6) 2018, the pt returned to the clinic for follow-up and was prescribed flumetholon ophthalmic suspension 0.1% qid, bestron for ophthalmic qid, cravit ophthalmic solution 1.5% qid, keflex oral medicine 4 tablets/day and tarivid eye ointment.No infusion.A very small scar is still remaining.No follow-up visit was scheduled.On 01mar2018 the sales representative provided the additional information: on (b)(6) 2018 the pt returned to the clinic and the ecp confirmed recovery.The ecp prescribed cravit ophthalmic solution 1.5%.No additional medical information was 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.

• 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: 7321322
• MDR Text Key: 101778435
• Report Number: 1057985-2018-00024
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/06/2018

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2018
• Initial Date FDA Received: 03/07/2018
• 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