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

Catalog Number PH

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

Patient Problems Erosion (1750); Conjunctivitis (1784); Corneal Ulcer (1796); Foreign Body Sensation in Eye (1869); Pain (1994); Swelling (2091); Discharge (2225)

Event Date 10/23/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4) corneal ulcer, (b)(4) erosion, (b)(4) pain, (b)(4) swelling, (b)(4) discharge, (b)(4) conjunctivitis, (b)(4) foreign body sensation, (b)(4) device not returned, (b)(4) no findings available, (b)(4) no problem detected, (b)(4) contact lens, (b)(4) adverse event without identified device or use problem.

Event Description

On (b)(6) 2020 a patient (pt) called to report a film developed on the lenses within minutes while wearing the acuvue® oasys® brand contact lenses (cls).The pt reported the suspect cls ¿looked dirty¿ upon removal.On 04nov2020 additional information was provided by the pt.The pt had a cls exam on (b)(6) 2020 and had no issues.The pt opened a new cls on (b)(6) 2020 and reports os pain and swelling.The pt removed the suspect os cls and noted a black mark that looked embedded in the lens that didn¿t rinse off with disinfectant.The pt put in a second lens that felt ¿very filmy and cloudy¿ and felt like an eyelash on the eye.The pt tried to rinse the lens but had to wear it all day while working.The pt reported symptoms of upper and lower lid swelling.The pt went to an urgent care on sunday due to os pain and was prescribed ofloxacin 2 drops os qid for 5 days for ¿unspecified acute conjunctivitis.¿ the pt was advised if the symptoms were not better by tuesday, the pt should consult an ophthalmologist.The pt reported an additional symptom of foreign body sensation and the ofloxacin drops didn¿t help.The pt went to an ophthalmologist today and was diagnosed with an os marginal corneal ulcer.The pt was prescribed tobramycin-dexamethasone 1 drop tid and no cls wear.The pt has a follow-up appointment next wednesday at 1:30.Additional medical information was requested.On 05nov2020, an email was received from the pt reporting a follow-up appointment scheduled next week with the ophthalmologist.On 09nov2020 a call was received from the pts treating ecp and additional medical information was provided.The ecp advised the pt was diagnosed with an os mild marginal corneal ulcer and prescribed with tobramycin-dexamethasone 1 drop os tid.The treatment was standard in the office and the event was determined to be mild and not infectious.The os va was not affected.At this time the diagnosis of os mild marginal corneal ulcer was not determined to be a serious medical event.On 04dec2020 the pt provided medical reports for dates of visit (b)(6) 2020.Date of visit: (b)(6) 2020, urgent care visit with complaints of eye discharge.The pt was diagnosed with ¿unspecified acute conjunctivitis os.¿ the pt was advised to wash hands frequently, apply warm compress and prescribed an eye drop (not noted on medical record provided) as directed.The pt was advised to follow-up with ophthalmology if no relief or experienced worsening symptoms in 24-48 hours.Date of visit: (b)(6) 2020 the pt presented to ecp with complaints of os foreign body sensation.The pt was diagnosed with marginal os corneal ulcer, age related incipient cataract, bilateral.The pt was prescribed tobramycin-dexamethasone 1 drop os tid and advised to continue the ofloxacin previously prescribed.Pt was advised to follow-up in 1-2 weeks.Date of visit: (b)(6) 2020 the pt presented for a follow-up visit.Pt was diagnosed with os marginal corneal ulcer; blepharitis ou upper and lower eyelids; age-related incipient cataract, bilateral.The pt was advised with continue tobramycin-dexamethasone 1 drop os tid and taper drops to 1 drops/week.No significant improvement in corneal ulcer symptoms were noted and no sign of active inflammation.Symptoms likely multifactorial with a component of blepharitis.Lid hygiene, warm compresses, and frequent use of artificial tears with application of erythromycin to lids at bedtime were recommended.On 14dec2020 the pt called to provided additional information.The pt returned for follow-up visit today, where the ecp now diagnosed os corneal erosion and the eye is still swollen.The pt advised the ecp thinks it is because of the removal of the lens every day that is not allowing the eye to heal.No treatment information was provided.The pt reported that the ecp recommends a daily cls and if that doesn¿t work, try a lens for 30 days extended.On 15dec2020 the pt provided medical receipts, medical records previously received for date of visit (b)(6) 2020.New medical records were received for pt date of visit (b)(6) 2020.14dec2020: 1-month follow-up: the pt was diagnosed with recurrent corneal erosion os, unspecified blepharitis ou (upper and lower eyelids) and age-related incipient bilateral cataract.The tobramycin drops were discontinued.The pt is to follow-up again in 2-3 weeks.On receipt of the additional medical information provided 15dec2020, the diagnosis os event of recurrent corneal erosion was considered to be a serious reportable medical event.On 06jan2021, a call was placed to the pt who reported a scheduled follow-up appointment in about 2 weeks.No additional medical information has been received.Additional medical information was requested.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 b00vwg8 was produced under normal conditions.The suspect os contact lens was discarded.No additional investigation can be conducted.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

On (b)(6) 2021 the patient (pt) provided a medical report for date of visit (b)(6) 2020.Date of visit: (b)(6) 2020.Reason for visit: pt here for fu recurrent corneal erosion (rce) os today¿s dx: recurrent erosion of cornea, os; unspecified blepharitis os, upper and lower eyelids; age related incipient cataract os comments: recurrent erosion of cornea, left eye: no active ulcer today.Symptoms suspected to be 2nd to rce.Offered bcl, but pt defers (normally wears contact lenses and feels she could not tolerate this with the way her eye feels).Continue muro gtts qid, ung qhs.Sample given of prolensa to use qd.Ok to use tobradex qd sparingly.Return appointment: (b)(6) 2021 @ 8:00am.The pt also reported the os seems to have healed from the ulcer and the pt is beginning to return to wear daily contact lenses without irritation.No additional medical information was provided.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. ¿ US; 7500 centurion parkway; jacksonville FL
• MDR Report Key: 11131360
• MDR Text Key: 234285363
• Report Number: 1057985-2021-00001
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): Y
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• 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: B00VWG8
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/26/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 50 YR