MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE - IRELAND 1-DAY ACUVUE MOIST; LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number 1DM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Conjunctivitis (1784); Corneal Edema (1791); Corneal Scar (1793); Keratitis (1944); Local Reaction (2035); Red Eye(s) (2038); Visual Disturbances (2140); Excessive Tear Production (2235); Eye Pain (4467)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Suspect product discarded.

Event Description

On (b)(6) 2021, an eye care provider (ecp) in (b)(6) reported a patient (pt) experienced eye inflammation while wearing the 1-day acuvue® moist® brand contact lenses (cl).On (b)(6) 2021, the pt was contacted, and additional information was received.The pt reported discomfort and tearing os upon insertion of the cl on (b)(6) 2021.Upon cl removal, the pt experienced redness, swelling, tearing, and could not open os.The pt visited an ecp on (b)(6) 2021 and was diagnosed with conjunctivitis.The ecp prescribed ganciclovir, tobramycin, and oflaxacin eye drops, to use 4-5 timer per day.The pt reported the eye did not recover after using the medications, so the pt visited another hospital on (b)(6) 2021.The doctor diagnosed the pt with keratitis and prescribed pranoprofen, levofloxacin, and clindamycin eye drops (unspecified frequency, dosage, duration).The pt confirmed that only the os was affected.On (b)(6) 2021, additional information was provided by the pt.The pt only used pranoprofen, levofloxacin, and clindamycin eye drops for several hours yesterday and the eye felt very uncomfortable when using the medications.The pt reported the eye swelling was ¿more serious¿ yesterday afternoon, and the pt experienced increasing discharge today with difficulty opening the eye.The pt visited a doctor again and was prescribed gatifloxacin, deproteinised calf serum, and cefprozil tablets, to be used 3 times a day.The pt mentioned the doctor advised to stay in the hospital.On (b)(6) 2021, additional information was provided by the pt.The pt reported the od experienced eye swelling and tearing today.The pt visited a doctor who advised the os ¿infected¿ the od.The pt was prescribed ganciclovir eye ointment to use 6-8 times per day for os and 4 times per day for od, fluorometholone drops to 3 times per day, and levofloxacin drops to use once every half hour.The doctor instructed the pt to discontinue the previously prescribed medications.On (b)(6) 2021, the pt was contacted, and additional information was provided.The eyes are gradually recovering but continues to experience swelling, tearing, and more recently experiencing photophobia.The doctor gave the pt an infusion of aciclovir and vitamin c for 3 days and advised to have an additional 7 days of the infusion.On (b)(6) 2021, the pt reported the doctor believes the infection is a combination of viral and bacterial, with a higher chance of viral infection.On (b)(6) 2021, the pt¿s medical report was received.Date of visit: (b)(6) 2021.Conjunctival congestion in left eye (other documentation is unreadable).Diagnosis: conjunctivitis of left eye.Medication: levofloxacin eye drops; tobramycin eye drops; ganciclovir eye drops.Date of visit: (b)(6) 2021.Medical history: pain in both eyes, tears for more than 3 days.Contents of inspection: conjunctival congestion and edema in both eyes.Spot-like turbidity in the stromal layer of the cornea in both eyes.Diagnosis: 1.Keratitis of both eyes; 2.Conjunctivitis of both eyes; 3.Ametropia medication: pranoprofen eye drops, 4 times a day 0.05 ml each time; levofloxacin eye drops, 4 times a day 0.05 ml each time; clindamycin palmitate hydrochloride dispersible tablets, 1 tablet 3 times a day.Medical advice and suggestions: rest for a week.Date of visit: (b)(6) 2021.Medical history: pain in both eyes and tears.Both eyes are red and swollen.Contents of inspection: both eyes are red and swollen.Obvious swelling of the eyelids, hyperemia and edema of the bulbar conjunctiva, and spot opacity on the corneal surface.Diagnosis: 1.Keratitis of both eyes; 2.Conjunctivitis of both eyes; 3.Ametropia medical advice and suggestions:1.Need to be hospitalized; 2.Covid-19 examination.Date of visit: (b)(6) 2021.Medical history: pain in both eyes and tears.Contents of inspection: the left eye is swollen, conjunctival hyperemia and edema, corneal epithelial gray spots, slightly edema above and below the cornea, conjunctival follicle, and the anterior chamber is clear.Conjunctival hyperemia in the right eye, a little edema on the inside of the conjunctiva, gray spots on the corneal epithelium, and clear anterior chamber.Wbc 4.6×10¿/l diagnosis: 1.Keratitis of both eyes; 2.Corneal degeneration of both eyes; 3.Ametropia.Medical advice and suggestions: 1.Gatifloxacin eye drops, 4 times a day ; 2.Fluorometholone eye drops, 4 times a day; 3.Ganciclovir eye drops, 6 times a day; 4.Sodium hyaluronate eye drops, 4 times a day; 5.Ganciclovir ophthalmic gel, use it once before going to bed; 6.0.9%nacl 250ml, aciclovir injection 0.25, 5% glucose injection 250ml, vitamin c 2.0; 7.Review tomorrow.Date of visit: (b)(6) 2021.Sickness certificate: after examination by our hospital, it was diagnosed as: epidemic hemorrhagic conjunctivitis.Suggestions: 1.Pay attention to eye hygiene; 2.Follow-up review; 3.Rest for a week.On (b)(6) 2021, the pt was contacted, and additional information was received.The pt reported almost all the symptoms are resolved, however the doctor advised to continue using the medications prescribed on (b)(6) 2021 except for gatifloxacin.At the return visit yesterday, the doctor advised there are scars on the eyes.No further infusion is needed, but the pt was advised to take vitamin c.The pt has a return visit to the doctor next week.On (b)(6) 2021 additional medical reports were received from the patient (pt).Date of visit: (b)(6) 2021 ophthalmology visit.Medical history: pain in both eyes, tears for 3 days.Contents of inspection: conjunctival congestion and edema in both eyes; spot-like turbidity in the stromal layer of the cornea in both eyes.Diagnosis: keratitis ou; conjunctivitis ou; ametropia.Medication: pranoprofen eye drops qid; levofloxacin eye drops qid; clindamycin palmitate hydrochloride dispersible tabs-one tablet tid.Date of visit: (b)(6) 2021.Chief complaint: pain in both eyes.Inspection: conjunctival congestion and edema in both eyes; dot staining of cornea in both eyes.Diagnosis: conjunctivitis nos.Medication: gatifloxacin eye drops tid; cefprozil tabs, take 1 by mouth tid; recombinant bovine basic growth factor eye drop, tid.Date of visit: (b)(6) 2021.Inspection: redness and swelling of both eyes basically subsided; the conjunctival congestion of the od basically subsided; the conjunctival congestion of the os lower eyelid, the linear scar can be seen, no obvious edema of the cornea; clear anterior chamber.Medication: gancyclovir eye drops qid; sodium hyaluronate eye drops qid; vitamin c; fluorometholone eye drops os bid for 5 days, then once a day for 5 days follow-up review.On (b)(6) 2021 the pt reported the od suspect lens was discarded.The pt also reported the doctor stopped all antibiotics on a return visit on (b)(6) 2021, but kept antiviral medications, indicating a viral infection.No additional medical information was received.The suspect os product has been discarded.No additional evaluation can be conducted.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 3996740112 was produced under normal conditions.This report is for the pt¿s os event.The event for the pts od will be filed in a separate report.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

On 10feb2021 follow-up 1 for mdr # 9617710-2021-00102 was submitted to the fda.It was noted in a file review on 08mar2021 that section e.1., initial reporter country was submitted as united states in error.The correct initial reporter country is china.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

On 26jan2021 a call was placed to the patient (pt) who reported the eyes have recovered and no additional follow-up visits to the eye care provider is needed.The pt continues to use sodium hyaluronate tid and vitamin c.All other medications were discontinued.No additional medical information was provided.This report is for the pts os event.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: 1-DAY ACUVUE MOIST
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE - IRELAND; 1 technological park plassey; limerick, limerick LK130 01; EI LK13001
• MDR Report Key: 11229315
• MDR Text Key: 232639278
• Report Number: 9617710-2021-00102
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• PMA/PMN Number: N18033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup,Followup
• Report Date: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 1DM
• Device Lot Number: 3996740112
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention