MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE - IRELAND ACUVUE OASYS; LENSES, SOFT CONTACT, EXTENDED WEAR

Catalog Number PH

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

Patient Problems Chemosis (1775); Corneal Edema (1791); Corneal Scar (1793); Iritis (1940); Keratitis (1944); Red Eye(s) (2038); Visual Disturbances (2140); Excessive Tear Production (2235); Eye Pain (4467)

Event Date 05/01/2021

Event Type  Injury  

Event Description

On (b)(6) 2021 a patient (pt) in (b)(6) called to report discomfort and pain in the left eye (os) while wearing the acuvue® oasys® brand contact lens (cls).The pt visited a clinic and the doctor who examined the pt advised ¿something had been rubbed into the eye¿.The suspect cls in the os was observed to be fine.The pt was prescribed ¿antibiotic and drops¿.After the treatment the pt developed photosensitivity.On 20jul2021 additional information was provided.The date of the event is reported as (b)(6) 2021.The diagnosis is reported as acute keratouveitis.The pt was prescribed nevanak eye drops 0.1% 5ml fl-cap 1 drop 3 times a day for 7 days; dexamethasone, eye drops 0.1%, 5 ml, 1-2 drops, 4-5 times a day; vigamox, eye drops 0.5%, 5 ml, 1 drop 3 times a day for 7 days.On 02aug2021 additional information was provided.The pt is still currently under medical supervision.The os remains uncomfortable.The pt continues nevonak, vigamox and dexamethasone eye drops.The pt enclosed the medical records for four appointments.Date of visit: not reported.Complaints: redness, lacrimation ¿within a week¿ from os.Left eye: edema of the mucous membranes, pericorneal injection, no discharge, edema of the corneal epithelium, precipitates, transparent moisture, slight blurring of the iris.Diagnosis of the underlying disease: acute and subacute iridocyclitis os; clinical diagnosis: acute keratouveitis os.The patient is recommended to be monitored by an ophthalmologist and a second consultation after one year.On 03aug2021 additional translation of the pts medical records were provided: date of visit: (b)(6) 2021.Complaints: redness and lacrimation os for a week; no decrease in visual acuity.Os: clinical features of conjunctival edema, limbal injection, corneal edema, precipitates in the back surface of the corneal, slight shading of the iris pattern.Diagnosis: acute iritis.The pt was prescribed antibiotics, corticosteroids, and cornea-protector drugs.Date of visit: (b)(6) 2021 ¿ ¿positive trend¿.Os: clinical features of low conjunctival hyperemia peripheral corneal opacity on 2-3 o'clock.The treatment was continued.Date of visit: (b)(6) 2021: ¿positive trend¿.Residual manifestations of the disease.Continues to apply corticosteroids, and cornea-protector drugs.Date of visit: (b)(6) 2021.Os: the eye is calm, the cornea is transparent, at 3 o'clock there is a transparent subepithelial opacity.Diagnosis outcomes os: recent corneal opacity.Treatment completed.Moisturizing drops were recommended.The pt has returned to cls wear acuvue oasys, daily wear, one month ago.The eye condition is reported as normal.No additional medical information has been received.No additional medical information is expected.One opened lens case containing two lenses for lot number l004dg5.The parameters of the two opened lenses were measured and a visual inspection was performed.The lenses met company standards for power, base curve, center thickness, and diameter.No visual attributes were observed for the two opened lenses.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 l004dg5 was produced under normal conditions.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: ACUVUE OASYS
• Type of Device: LENSES, SOFT CONTACT, EXTENDED WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE - IRELAND; 1 technological park plassey; limerick LK130 01; EI LK13001
• MDR Report Key: 12320923
• MDR Text Key: 282226489
• Report Number: 9617710-2021-00114
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: PH
• Device Lot Number: L004DG5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention