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 Corneal Abrasion (1789); Corneal Scar (1793); Corneal Ulcer (1796); Dry Eye(s) (1814); Eye Injury (1845); Hypopyon (1913); Unspecified Infection (1930); Irritation (1941); Red Eye(s) (2038); Swelling (2091); Excessive Tear Production (2235); Discomfort (2330)

Event Date 09/28/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On 02oct2020 an email was received from an online distributor who reported a patient (pt) "believed the contacts are contaminated and caused an infection." the pt was wearing an acuvue(r) oasys(r) brand contact lens at the time of the event.No additional information was provided.Multiple attempts were made to contact the pt for additional medical and product information.On 04dec2020, a call was received from the pt who provided additional information.The pt put a new lens from a contact lens package in the od on a monday in (b)(6) 2020.The pt advised the od lens "felt weird, like it was inside out" so the pt removed the suspect lens, flipped the lens and reinserted it.At that time the pt could tell the lens was inside out.The pt noted nothing was visibly wrong with the suspect lens.The pt reported the lens felt weird all day.The pt woke the following day and called the primary care provider (pcp) because the "eye was white." the pcp advised the pt that it could be an infection and prescribed an antibiotic drop (name of the eye drop was unknown).The pcp advised the pt to call an ophthalmologist if not resolved in 3-5 days.The pt did not see the pcp due to the pandemic.The pt woke the following day and went to an eye care provider (ecp) because the pt "was blind in the od." the pt was prescribed moxifloxacin eye drop every hour, 24 hours, for months.The ecp "scraped and cultured the eye" but could not determine what organism caused the infection.The pt was referred to a specialist and was on a cornea transplant list.The pt advised the eye is healed and the pt is no longer on the cornea transplant list.Additional medical and product information was requested.The pt agreed to email the suspect od lot number, medical records and treating ecp information so additional information could be requested.The pt has tried to think of anything that could have caused the event, to no avail, and had not just cleaned the bathroom before inserting the suspect od lens.No additional information was provided.The date of event is (b)(6) 2020.On 08dec2020 a call was placed to the pts pcp for additional medical information.A representative reported the pt was seen on (b)(6) 2020 for possible eye infection.No additional medical information was provided.Multiple attempts were placed to the pts treating ecp for additional medical information, but nothing additional has been received.Multiple attempts were placed to the pt for additional medical and product information, but nothing additional has been received.No additional medical information has been received.The od suspect lot number is unknown.The pt refused to return the od suspect lens for evaluation.No additional investigation can be conducted.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

On 08dec2020, the treating primary care physician (pcp) office was contacted, and a representative reported the patient (pt) was seen on (b)(6) 2020 for ¿swollen eyes¿ and again on (b)(6) 2020 for a ¿possible eye infection.¿ the medical event for the pt¿s ¿possible eye infection¿ was reported to the fda on 18dec2020, mdr # 1057985-2020-00077.Multiple attempts were made to the pt and treating eye care provider (ecp) to obtain additional medical information for both the (b)(6) 2020 and (b)(6) 2020 medical events.No further information was received.On 29dec2020, an email was received from the pt providing the suspect contact lens lot # boovbmm for the (b)(6) 2020 event.The pt reported only the od was affected.On 06jan2021, an email was received from the pt with medical records from the treating ecp for the (b)(6) 2020 event.Date of visit: (b)(6) 2020.Patient presented for evaluation of corneal abrasion.Current prescriptions: tobradex.Impression: corneal ulcer with hypopyon, od; combined forms of age-related cataract, bilateral; dry eye syndrome of bilateral lacrimal glands; presbyopia, bilateral.Plan: cultures done today at slip lamp.No contact lens wear.Od: stop tobramycin.Start moxifloxacin every hour around the clock.Cyclogyl 3 times a day.Return for follow-up in 2 days (friday).Other medical records received were un-readable.On 08jan2021, a call was placed to the pt to confirm if the pt had experienced two separate events or one single medical event.The pt confirmed there was one event which started on (b)(6) 2020 and not (b)(6) 2020, as previously reported.The two events will now be reconciled as one medical event.The pt reported the event occurred after wearing an acuvue® oasys® cl from lot # boovbmm all day after experiencing discomfort od on initial insertion on (b)(6) 2020.The cl felt like it was inside out, so the pt removed the od cl, flipped it over and reinserted it in the od.The pt continued to wear the od suspect cl an additional 5 hours despite it being uncomfortable.Upon removal of the suspect od cl, the od was very red and irritated.The next morning on (b)(6) 2020, the pt called the pcp and was prescribed an antibiotic drop.The pt reported the od is currently fine and the infection has resolved.The pt will not return to contact lens wear and is currently wearing glasses.The visual acuity in the od was not affected; the pt currently has od dry eye since the event resolved.The pt will re-send the un-readable medical records if able to print them.The suspect od contact lens was requested for return for evaluation but has not yet been received.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 boovbmm was produced under normal conditions.If any further relevant information is received, a supplemental report will be filed.Section h.6.Evaluation codes: code 1796 - corneal ulcer.Code 1913 - hypopyon.Code 1789 - corneal abrasion.Code 2091 - swelling.Code 1814 - dry eye(s).Code 2038 - red eye(s).Code 1941 - irritation.

Manufacturer Narrative

On (b)(6) 2021 the patient (pt) sent additional medical records and advised the next appointment is (b)(6) 2021 with the eye care provider.Medical records summary: date of visit: (b)(6) 2020.Pt presents for evaluation of: corneal abrasion.Impression: corneal ulcer with hypopyon, od; age-related cataract, bilateral.Dry eye syndrome of bilateral lacrimal glands; presbyopia, bilateral plan: cultures done today at slit lamp.No cls wear.Od: stop tobramycin.Start moxifloxacin every hour around the clock and cyclogyl 3x/day.Return to clinic on 2 days.Date of visit: (b)(6) 2020.Reason for visit: corneal ulcer with hypopyon.Medication od: moxifloxacin 0.5% eye drops, 1 drop every hour; cyclogyl 1% eye drops, 1 drop 3x/day.Impression: corneal ulcer with hypopyon, od - significant improvement on current treatment.Plan: no cls wear.No water in the eye, avoid dusty or dirty environments od: continue moxifloxacin every hour around the clock and cyclogyl 3x/day.Return to clinic in 3 days.Date of visit: (b)(6) 2020.Reason for visit: corneal ulcer with hypopyon.Medication od: moxifloxacin 0.5% eye drops, 1 drop every hour; cyclogyl 1% eye drops, 1 drop 3x/day.Impression: corneal ulcer with hypopyon, od - improving on current treatment.Plan: no cls wear.No water in the eye, avoid dusty or dirty environments.Od: continue moxifloxacin every hour around the clock.Stop cyclogyl.Follow-up in 4 days, stressed sooner if any decrease in vision or increase in pain or light sensitivity.Date of visit: (b)(6) 2020.Reason for visit: corneal ulcer with hypopyon.Medication od: moxifloxacin 0.5% eye drops, 1 drop every hour.Impression: corneal ulcer with hypopyon, od - significant improvement on current treatment.Plan: no cls wear.No water in the eye, avoid dusty or dirty environments.Od: continue moxifloxacin every hour while awake - can decrease to every 2 hours overnight.Return in 1 week.Date of visit: (b)(6) 2020.Reason for visit: corneal ulcer with hypopyon.Medication od: moxifloxacin 0.5% eye drops.Impression: corneal ulcer right eye - improving on current treatment.Hypermetropia, bilateral, presbyopia, bilateral.Plan: new glasses, rx given today.Od: continue moxifloxacin every hour while awake, can decrease to every 4 hours overnight.Return in 7-10 days.Date of visit: (b)(6) 2020.Reason for visit: corneal ulcer with hypopyon.Medication: moxifloxacin 0.5% eye drops.Impression: corneal ulcer with hypopyon, od - appears nearly resolved to a scar.Plan: od: continue moxifloxacin every hour while awake and every 4 hours overnight for one more week, then stop.Return in 2 weeks.Date of visit: (b)(6) 2020.Reason for visit: corneal ulcer.Medication: moxifloxacin 0.5% eye drops.Impression: corneal ulcer with hypopyon, od - resolved to a scar.Dry eye syndrome of bilateral lacrimal glands.Hypermetropia, bilateral; presbyopia, bilateral.Plan: od, stop moxifloxacin.Return in 4-6 weeks.No additional medical information has been received.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

On 28mar2022 the patient (pt) provided additional medical reports by email.Date of visit: (b)(6) 2020.Pt presents for resolving corneal ulcer, cataract impression: combined forms of age-related cataract, bilateral.Dry eye syndrome of bilateral lacrimal glands.Hypermetropia: bilateral.Presbyopia: bilateral.Plan: return in 3-4 weeks.Od: stop moxifloxacin.Stop visine.Use refresh optive preservative free tears in both eyes.Date of visit: (b)(6) 2021.Impression: dry eye syndrome of bilateral lacrimal glands - improved with very frequent tears, but still significant symptoms and staining.Plan: discussed rx dry eye drops vs bilateral lid punctal plugs.Pt elects to move forward with rx dry eye drops.Continue frequent refresh optive preservative free artificial tears (do not decrease at all).Add cequa - 1 drop to ou 2x/day.Receipt dated: 10/09/2020 for moxifloxacin 0.5%, instill 1 drop in the od every hour around the clock.Receipt dated: 10/02/2020 for moxifloxacin 0.5%, instill 1 drop every hour around the clock in the od.Receipt dated: 10/07/2020 for moxifloxacin 0.5%, instill 1 drop in the od every hour around the clock.Receipt dated: 09/30/2020 for cyclopentol 1%, instill 1 drop into od three times daily.No additional medical information has been received.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
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 11040009
• MDR Text Key: 222671550
• Report Number: 1057985-2020-00077
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• 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: B00VBMM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 51 YR
• Patient Sex: Female