MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND ACUVUE ADVANCE; LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number AVG

Device Problem No Apparent Adverse Event (3189)

Patient Problems Conjunctivitis (1784); Dry Eye(s) (1814); Foreign Body Sensation in Eye (1869); Itching Sensation (1943); Pain (1994); Red Eye(s) (2038); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On 01aug2017, our affiliate in (b)(6) received a call from a patient (pt) who reported experiencing eye pain, eye itching, and foreign body sensation while wearing acuvue advance contact lenses.Pt presented to a hospital on (b)(6) 2017 and reported being diagnosed with conjunctivitis in both eyes (ou) and being prescribed anti-inflammatory eye drops.Pt reported being prescribed tobramycin eye drops (used hourly), ofloxacin ointment (once a day) and amoxicillin and clavulanate potassium tablets (twice a day).Pt reported he/she would provide a copy of the medical report.Pt reported the product in question was available for return.Pt reported the symptoms began (b)(6) 2017.On (b)(6) 2017, a copy of the pts medical report was received: date of visit: 15:01, (b)(6) 2017.Chief complaint: feel foreign body sensation in both eyes for more than 3 days present history: the patient began to feel foreign body sensation and had redness in both eyes 3 days before.The patient do not have any eye distension, nausea and vomiting, headache and dizziness.The patient comes to our hospital today for treatment.Previous history: none.Physical examination: conjunctiva hyperaemia, cornea transparent, tyn¿s(-), pupils equal and reactive to light.Accessory examination: none.Prescription: anti-inflammatory and symptomatic treatment.Follow-up visit if any discomfort.On (b)(6) 2017 a call was placed to the pt and additional information was provided: pt reported he/she was still receiving treatment with a different kind of eye drop while in china; pt reported he/she was traveling in (b)(6)and will return home on (b)(6) 2017.On (b)(6) 2017 a follow-up call was placed to the pt and the additional medical information was obtained as follows: the pt reported he/she is still under treatment, but the treating regimen had changed; pt states he/she has not returned to wear cl since (b)(6); the pt states the ecp told the pt he/she had acute conjunctivitis and a bit dry eye syndrome; the pt reported he/she will provide the 2nd hospital visit.Multiple follow up calls were placed to the treating hospital for additional information, but no additional medical information was received.This event is being reported as a worst case event for the pts od event as it was not possible to confirm the pts diagnosis and treatment with the treating hospital.The pts os event will be submitted in a separate report.A lot history review was performed for lot l0032rv: 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 l0032rv was produced under normal conditions.One opened contact lens case was received which contained two suspect lenses; the parameters of the two lenses were measured and a visual inspection was performed.The lenses met company standards for base curve, center thickness, and diameter.The visual inspection revealed no visual attributes observed on the two lenses.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 11sep2017 our affiliate in (b)(6) received additional information from the pt via email.On 15sep2017 the medical information was received from translation with the following additional information as follows: -medical certificate dated (b)(6) 2017: patient (pt) was prescribed tobramycin, dexamethasone eye drops; vislube (sodium hyaluronate 0.18%), 1 drops in ou every 2 hours; pataday (olopatadine hydrochloride ophthalmic solution 0.2%), once daily morning.-medical report dated 26aug2017: -date of visit: (b)(6) 2017.Chief complaint: eye pain and eye strain feeling for more than 1 month; (with hyperthyroidism and hypothyroidism).Physical examination: some of the meibomain gland orifices were blocked, papillary hyperplasia in superior palpebral conjunctiva, cornea (-); iop: od 15.3mmhg, os 16.3mmhg; c (exam unk): od 5, os 9 ocular surface analysis; b scan: vitreous opacity diagnosis: conjunctivitis; dry eye; vitreous opacity b scan: ou vitreous opacity nibut:od:initial breakup time 2.87 second, average breakup time 3.16 second, grade 2;os:initial breakup time 8.6 second, average breakup time 8.6 second, grade 1 tear meniscus height: od:0.26mm, os:0.31mm.On (b)(6) 2017 a call was placed to the pt for additional medical information: pt reported the eyes were still feeling painful and itchy occasionally, after the last call, but stated eyes were feeling better today; pt confirmed that he/she has not worn lenses since the event in (b)(6) 2017; pt reported he/she will go for another follow-up appointment with the ecp tomorrow and will provide the medical report via email.No additional medical information has been received.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 (b)(6) 2017 the patients (pt) medical report was received and the additional information was provided.Date of visit: (b)(6) 2017.Chief complaint: feel foreign body sensation in both eyes for more than 3 days.Present history: the patient began to feel foreign body sensation and had redness in both eyes 3 days before.The patient do not have any eye distension, nausea and vomiting, headache and dizziness.The patient comes to our hospital today for treatment.Previous history: none.Physical examination: conjunctiva hyperaemia, cornea transparent, tyn¿s(-), pupils equal and reactive to light.Accessory examination: none.Prescription: anti-inflammatory and symptomatic treatment follow-up visit if any discomfort.Date of return visit: (b)(6) 2017.Distance visual acuity: od 0.1, os 0.1.Corrected distance visual acuity: od 0.6, os 0.6.Chief complaint: still feel the eyes itch and sore.Physical examination: lipid granules at the opening of meibomian glands of both upper and lower eyelids, conjunctival congestion, upper eyelid papilla, corneal (-), anterior chamber (-).Diagnosis: dry eye.Prescription: 0.02% fluorometholone eye drop, qid ou; 0.3% sodium hyaluronate eye drop, qid ou; vitamin a palmitate eye oculentum, qn ou; hot compress to make meibomian glands unobstructed.Follow-up visit after 1 month.Date of return visit: (b)(6) 2017.Illegible.Physical examination: ou meibomian glands illegible.Prescription: but: r 3 seconds, l 3 seconds illegible: r 2.1, l 2.1 illegible iop: r 16.10mmhg, l 16.3mmhg suggest opt.Prescription (b)(6) 2017.Polyethylene glycol eye drop (each ml: polyethylene glycol 4mg; propylene glycol 3mg) 1 bottle usage: 1ml qid ou vitamin a palmitate eye oculentum (5mg) 1 bottle usage: 0.25g qn ou receipt: treatment fee: rmb200, drug fee: rmb73.55.On (b)(6) 2017 a call was placed to the pt for additional medical information, but no additional information was received.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 11apr2018, the following additional information was received from the patient (pt): the pt visited the local hospital twice after the last communication in october 2017.The pt¿s eyes ¿felt fine¿ since (b)(6) 2018, after half a year of treatment.No additional information was received.If additional information is received, will report within 30 days of receipt.Serious reportable event trends are reviewed quarterly in franchise management review meetings.

• Brand Name: ACUVUE ADVANCE
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND; one technological park plasse; limerick ; EI
• MDR Report Key: 6826826
• MDR Text Key: 83866812
• Report Number: 9617710-2017-05035
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• PMA/PMN Number: K032340
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/01/2022
• Device Catalogue Number: AVG
• Device Lot Number: L0032RV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2017
• Date Manufacturer Received: 04/11/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention