MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND 1-DAY ACUVUE DEFINE WITH LACREON; LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number 1DL

Device Problem No Apparent Adverse Event (3189)

Patient Problems Corneal Scar (1793); Corneal Ulcer (1796); Inflammation (1932); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On apr.19, 2018 a johnson and johnson sales representative in (b)(4) reported a patient (pt) was hospitalized after developing inflammation (affected eye unknown) wearing inserting 1-day acuvue® define¿ with lacreon® contact lens (cls).Additional information was requested.On 19apr2018: the pt reported additional information: the end of (b)(6) 2017 or early (b)(6) 2017, the pt could not open the os while wearing the 1-day acuvue® define¿ with lacreon® for 3-4 hours.Pt reported the ¿cornea was on the verge of peeling away¿ and was unable to undergo exam.Pt was referred to a hospital and was hospitalized for 5 days due to a corneal ulcer os.Pt was instructed to discontinue cls wear and treated with stericlon, vigamox ophthalmic solution, ¿estron¿, odomel ophthalmic suspension and eye ointment (details unknown).Pt reports after discharge from the hospital the pt returned for 9 follow-up visits.On (b)(6) 2018 follow-up visit, pt was told that ¿cornea has formed pretty well but opacity is remaining¿.Pt will see an eye care provider (ecp) at a clinic and pt agrees to provide additional information.On 20apr2018: the treating hospital was contacted and a medical interview was requested.On 26apr2018 a call was placed to the pt and additional information was provided: on (b)(6) 2018: the pt had a follow-up visit at an eye clinic and was advised the pt had a corneal opacity.Pt was instructed to return in 1 month.Pt still has medication prescribed by the hospital.Pt was not prescribed any new medication.The pt refused to provide identification for release of medical information from the hospital, but agrees for contact for additional information in 1 month after follow-up appointment.No additional medical information has been received.All information received has been reported by the pt.We have been unable to confirm the pt diagnosis and treatment with the pts treating physician.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 3811120356 was produced under normal conditions.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.

Manufacturer Narrative

On 02jul2018 additional information was received from the affiliate: a call was placed to the eye care provider¿s (ecp) for a medical interview.The ecp reported that the patient (pt) did not return to the clinic in (b)(6) 2018.No additional medical information was provided.If any further relevant information is received, a supplemental report will be filed.Serious reportable event trends are reviewed quarterly in franchise management review meetings.

Manufacturer Narrative

On (b)(6) 2018, additional information was received from the patient (pt): on (b)(6) 2018, the pt went to the eye care provider (ecp) and reported no eye pain, but ¿little change¿ in the eye.No change in the corneal opacity and a follow-up (fu) visit scheduled in one month.On (b)(6) 2018, the pt¿s treating hospital was contacted for additional medical information.On (b)(6) 2018.The pts medical records were received with additional medical information: pts history of contact lens (cls) wear is unknown; but reported the pt wears soft cl on weekends and ¿hard¿ cl on weekdays.On (b)(6) 2017, the pt went to a hospital with complaints of os eye pain that began 20 days prior; diagnosis: corneal ulcer os, not infectious; no culture was taken; the corneal ulcer was slightly inferior from the central cornea os, size was not measured; corrected va: os 0.01.Treatment: vigamox ophthalmic solution, bestron for ophthalmic, stericlone drops q 2 hours, tarivide eye ointment before bedtime; cl wear discontinued; pt admitted to hospital for treatment.On (b)(6) 2017, pt¿s 3rd hospital day: improved; pain is improved; treatment of same eye drops were continued; no cl wear.On (b)(6) 2017: improved; finding: corneal opacity; treatment of same eye drops were continued; no cl wear; pt to return to hospital for fu.On (b)(6) 2018, the pt returned for fu visit; os unchanged; finding: corneal opacity; corrected va os: 1.2; treatment: vigamox ophthalmic solution and stericlone drops q 4 hours; no cl wear continued.On (b)(6) 2018 the pt returned for last visit: os unchanged; finding: same; treatment: flumetholon ophthalmic suspension 0.1% bid; no cl wear continued.Pt was referred to an eye clinic for fu.On (b)(6) 2018, additional medical records were received from the pts ecp: the pt was wearing the 1-day acuvue moist brand contact lenses.On (b)(6) 2017 the pt reported pain os and went to an eye clinic, but the symptoms continued.On (b)(6) 2017 pt presented with complaints of os eye pain and vision decrease; pt was diagnosed with os corneal ulcer 2 x 2 mm ¿inferior part of the central cornea¿, culture not taken.The symptoms had improved temporarily, but worsened on the return visit on (b)(6) 2017.The pt was referred to the hospital with corrected va os 0.7, unaided va os 0.08; treatment: bestron for ophthalmic, vigamox ophthalmic solution, hyalein ophthalmic solution all qid os.Cl wear discontinued.On (b)(6) 2018 fu visit: improved; slight opacity; treatment: flumetholon ophthalmic suspension; no cl wear.Return to clinic as instructed.On (b)(6) 2018, the pts ecp was contacted and additional information was provided: (b)(6) 2018, the pt presented for fu after hospital discharge.Pt was instructed to on discontinue cl wear for 6 months to ¿rest the cornea¿.The pt was advised to return to the clinic monthly for eye check.Ecp reported the flumetholon ophthalmic suspension 0.1% bid, ¿is not required semipermanently¿.If the pt is allowed to return to cl wear, regular eye exams will be advised.No additional information has been received.If any further relevant information is received, a supplemental report will be filed.Serious reportable event trends are reviewed quarterly in franchise management review meetings.Evaluation codes: code 1994 - pain.Code 1793 - corneal scar.

• Brand Name: 1-DAY ACUVUE DEFINE WITH LACREON
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND; one technological parkway; limerick ; EI
• MDR Report Key: 7512413
• MDR Text Key: 108233211
• Report Number: 9617710-2018-05032
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): Y
• PMA/PMN Number: N18033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/02/2018

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 Expiration Date: 11/01/2020
• Device Catalogue Number: 1DL
• Device Lot Number: 3811120356
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/19/2018
• Initial Date FDA Received: 05/14/2018
• Supplement Dates Manufacturer Received: 05/26/2018; 07/02/2018
• Supplement Dates FDA Received: 06/20/2018; 07/25/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability