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

Catalog Number PH

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

Patient Problems Dry Eye(s) (1814); Foreign Body Sensation in Eye (1869); Headache (1880); Keratitis (1944); Pain (1994); Red Eye(s) (2038); Swelling (2091); Burning Sensation (2146); Dizziness (2194)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2020, a distributor reported a patient (pt) in (b)(6) visited a hospital twice due to redness while wearing acuvue® oasys® brand contact lenses (cl).The pt is currently wearing glasses.Event date is 2020.It was reported that the pt¿s eyesight weakened due to the cl.No further information was provided.On (b)(6) 2020, additional information was received in an email correspondence between the pt and the distributor from (b)(6) 2020 through (b)(6) 2020: on (b)(6) 2020, the pt initially reported having an ¿eye infection¿ last week (unspecified date).The pt used acumed solution for soft lenses.On (b)(6) 2020, the pt reported visiting the hospital emergency room (er) for a second time on (b)(6) 2020 due to ¿left eye (os) turned extremely red and burned incredibly,¿ eyesight decreased, dizziness, and severe headache.The pt previously visited the er a week earlier (unspecified date) due to the ¿cls being out of order.¿ the pt was diagnosed with ¿conjunctivitis sicca, myopia.¿ the pt¿s treatment lasted 14 days and required different eye drops (unspecified) 6 times a day as well as occasional pain pills.The pt reported the doctor stated the pt ¿saw 60% in left eye.¿ on (b)(6) 2020, the pt reported that while using two suspect cls, the pt¿s eye ¿became infected¿ over the course of two weeks.The pt is still currently experiencing severe headaches.After using the prescribed medication, the pt reported that the os is very dry and still does not feel ¿healthy.¿ the pt must use eye drops otherwise a ¿strong film forms on the eye, which limits normal everyday vision and makes it exhausting.¿ the optician advised that the os was ¿deteriorating by 0.75 diopters and by a greater corneal curvature.¿ the pt required new glasses due to an ¿increasing weakness in the strength of os.¿ on (b)(6) 2020, the pt reported that at the first visit to the er (unspecified date), the pt was advised to discontinue cl wear for a week, but no medication was prescribed.There is no medical report available for the pt¿s first visit to the er.The redness disappeared after a week and the pt resumed cl wear with a new cl for 6 hours, at which time the pt experienced severe redness and ¿vision loss.¿ the pt reported that a local doctor gave the pt a ¿private prescription¿ a few weeks prior and stated that glasses were needed.On (b)(6) 2020, the pt reported experiencing pain and problems with the os as well as a drastic change in the os.The pt visited an ophthalmologist last week (unspecified date) for a check-up.The ophthalmologist determined that the os had ¿deteriorated again by -0.25.¿ the pt was unwilling to send any further paperwork regarding the event.The pt reported still having the suspect cls that caused ¿pain and inflammation¿ but will have them examined privately.The pt¿s hospital report: the pt visited the outpatient clinic on (b)(6) 2020; diagnosis od: conjunctivitis sicca r/l: myopia; symptom/event: od: red eye and foreign body sensation; general: r/l since childhood same sight on both eyes, good vision.No previous medication used for eyes; findings: visual acuity: od without correction (sc): 0.8, os sc: 0,7p; t appl.: os - 12mmhg; vaa (ocular surface): od - eyelids normal, conjunctiva inj++, chemosis, ectropion normal, cornea superficial punctate keratitis across limbus, clear, reflecting, fluo regular, anterior chamber deep and clean, pupil round and plays, lens age appropriate; fd+ r/l: vision clear, vitreous body inconspicuous, papilla sharp-edged, vital, cdr 0.1, vessels perfused, macula inconspicuous, retina centrally located; medication: od - dexa-gentamicin at 4 times a day, thealoz duo gel bei bedarf as needed; evaluation: contact lenses should be paused, and a follow-up visit to a registered ophthalmologist was recommended.Letter from optician: pt was fitted correctly for cls in (b)(6) 2014 for 2-weekly acuvue oasys brand cls.Eyesight test on (b)(6) 2020: od sphere -5.25, cylinder -1.00, axis 180; os sphere -5.25, cylinder -0.75, axis 180 (rest of document is illegible).Dated (b)(6) 2018: od -5.50, -0.50, 0°; os -4.75, -0.50, 4°.Medical certificate: dated (b)(6) 2020.Letter from eye clinic: confirming visit of examination in the clinic on (b)(6) 2020.No additional information has been received.This event is being reported as a worst-case event as it is unknown if there was a significant decrease in vision because the pt has not had an eye exam since 2018.The pt is unwilling to return the suspect os cls.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 l00484p 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, INC. ¿ IRELAND; one technological park plassey; limerick ; EI
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 10374228
• MDR Text Key: 203631120
• Report Number: 9617710-2020-00015
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• 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: L00484P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention