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 Bacterial Infection (1735); Corneal Abrasion (1789); Corneal Ulcer (1796); Foreign Body Sensation in Eye (1869); Hypopyon (1913); Red Eye(s) (2038); Blurred Vision (2137); Eye Pain (4467)

Event Date 07/25/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, a patient (pt) in japan called to report discomfort and foreign body sensation on (b)(6) 2022 in the left eye (os) on day 8 while wearing an acuvue oasys brand contact lens (cl).After the pt removed the os suspect cl, the symptoms continued.The following morning, the pt reported redness and pain.On (b)(6) 2022, the pt went to an eye clinic and was diagnosed with an os corneal ulcer.The pt was instructed to discontinue cl wear for a week and return to the clinic every day.The pt was prescribed cravit ointment and tobracin (frequency not provided).The pt reported a culture of the cl was also taken.On (b)(6) 2022, the pt returned to the eye clinic and advised the symptoms were not improving.The cravit ointment was replaced with tarvid ointment and ofloxacin (frequency not provided) was also prescribed.The pt is to continue daily visits to the eye clinic and continue with no cl wear.On (b)(6) 2022, the pt returned to the eye clinic and advised the corneal ulcer was not improving.The pt was advised to continue daily clinic visits with no cl wear.On (b)(6) 2022, a call was placed to the eye clinic and additional information was provided.A representative advised the pt developed a corneal ulcer after using a cl.The culture taken is pending results.No additional medical information was provided.On 03aug2022, a representative at the eye clinic reported the pt returned on (b)(6), (b)(6)and (b)(6).The os corneal ulcer worsened, and the pt was referred to a hospital.The culture results arrived, but the pt¿s medical chart was not available at the time of the call.No additional medical information was provided.On 05aug2022, the pt reported that the pt¿s care of the cl case was bad, not the fault of the cl.Currently the pt has redness and discomfort, but reports the symptoms are better than before.The pt returned to the eye clinic on (b)(6) and (b)(6) and advised the ¿symptom not very well.¿ no medication was prescribed.On (b)(6) 2022, the pt was referred to a hospital.The pt was advised the culture detected no bacteria.The pt was advised to return on (b)(6) 2022.The pt was instructed to use cravit eye drops as previously prescribed (frequency not provided).The hospital is far from the pt, so the pt is advised to return to the eye clinic until the next hospital visit.On (b)(6) 2022, the pt went to the eye clinic to hear about the culture result.¿the culture detected pseudomonas aeruginosa.No medication was prescribed.¿ on (b)(6) 2022, the pt went to the eye clinic and advised the os corneal ulcer was improving a little.The culture for the lens case detected pseudomonas aeruginosa.The pt was prescribed tarvid eye drops (frequency not provided), continue no cl wear and return to the clinic on (b)(6) 2022.On 06aug2022, the pt reported ¿the symptom is getting better although the pt can¿t see very well.¿ on (b)(6) 2022, the pt went to the eye clinic and advised the ¿symptom¿ is improving with a ¿scratch coming up to the surface.¿ the pt was prescribed cravit eye drops (frequency unknown).The pt is to continue with no cl wear and return to clinic (date not provided).On (b)(6) 2022, the pt went to the hospital for a visit and was advised the ulcer was getting better.The pt will continue follow-up visits to see how much of the eyesight recovers.The pt continues to avoid cl wear and advised better not to use a 2-week cl in the future.The pt has a return appointment on (b)(6) 2022, until then the pt was instructed to return to the local eye clinic.No medication was prescribed.The pt plans to go to the eye clinic to get eye drops on (b)(6) 2022.On (b)(6) 2022, the pt reported the corneal ulcer is getting better gradually.The pt went to the eye clinic on (b)(6) 2022 and was advised that the doctor is starting to see healing.The pt was prescribed cravit (frequency not provided) and continue with no cl wear.The pt plans to return on or after the (b)(6) 2022.On 20aug2022, the pt provided additional information.The pt went to the eye clinic on (b)(6) 2022.The pt was advised to continue with no cl wear and was advised the eye is ¿fine.¿ the pt was not advised to return to the eye clinic unless the eye worsened.No medication was prescribed.The pt has a return visit to the hospital on (b)(6) 2022 to see how much eyesight recovers.No additional medical information has been received.Bacterial infection and ¿how much of the eyesight recovers¿ were not reported as we were unable to confirm the diagnoses with the treating doctor.Multiple attempts have been made to obtain additional medical information from the treating doctor, but nothing has been received.A lot history review was performed and revealed the following: the batch records did not show any abnormalities in monomer and solution testing.All parameters tested were within specification.All sterilization requirements were successfully completed.Lot number l004zcx was produced under normal conditions.The os suspect cl was requested for return for evaluation, but it has not been received.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

Suspect product requested, not received.

Manufacturer Narrative

On 26aug2022, additional medical information was provided from the treating eye clinic.Adverse event: pseudomonas aeruginosa corneal ulcer.Seriousness: serious, though no hospitalization; patient (pt) visited daily.Initial findings: on illustration of os, ¿small black dot was drawn on the center of central cornea.¿ outcome as of (b)(6) 2022: resolving.(b)(6) 2022 visit: patient (pt) presents with chief complaint of pain from the former day.Diagnosis: corneal ulcer; infection: yes; focal site: central influence on visual acuity: yes.Treatment: cravit; tobracin; ecolicin.Pt instructed to discontinue contact lens (cl) wear.Pt instructed to return to the clinic on the following day.27jul2022: follow-up (fu) visit.Outcome: symptoms worsened.Va: not tested.Treatment: tarivid, ofloxin (changed as pt had a strong pain).Pt instructed to continue with no cl wear.Pt instructed to return to the clinic on the following day.28jul2022 fu visit: outcome: symptoms worsened; findings: ulcer; va: not tested.Pt instructed to continue with no cl wear.Pt instructed to return to the clinic.29jul2022: fu visit: outcome: hypopyon +; va: not tested.Pt instructed to continue with no cl wear.Pt instructed to return to the clinic.30jul2022: fu visit: outcome: culture detected pseudomonas aeruginosa.Pt instructed to continue with no cl wear.Pt instructed to return to the clinic on the following day.03aug2022: fu visit outcome: ¿tendency to improve.¿ pt instructed to continue with no cl wear.Pt instructed to return to the clinic on (b)(6) 2022.05aug2022 fu visit: outcome: ¿tendency to improve.¿ va: not tested.Pt instructed to continue with no cl wear.Pt instructed to return to the clinic on (b)(6) 2022.10aug2022 fu visit: va: corrected va: os 1.2; naked va: os 0.1.Treatment: tarivid and cravit.Pt instructed to continue with no cl wear.Pt instructed to return to the clinic.On 13sep2022 additional medical information provided by the pt.The pt missed a visit to the eye clinic yesterday, due to family illness.The pt plans to return to the eye clinic on (b)(6) 2022.The pt confirmed the eye is getting better and the vision is ¿quite recovering too.¿ no additional medical information has been received.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

On 21sep2022, the patient (pt) provided additional information.On (b)(6) 2022, the pt returned to the eye clinic and was advised the vision is gradually improving and is ¿making good progress.¿ the pt was advised by the eye clinic that it was ok to return to contact lens wear for ¿several hours a day seeing how it goes.¿ the pt has a return visit to the eye clinic in 2 months for visual acuity exam.Cravit eye drops were prescribed (no details were provided.The pt has not yet returned to contact lens wear.On 21sep2022, a call was placed to the pt¿s eye clinic and a representative provided additional information.The pt advised it was ¿hard to see¿ so a visual acuity exam will be conducted in 2 months.A medical interview will be requested after the pt returns in 2 months.No additional information was provided.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

One opened contact lens case was received from the customer, which contained (b)(4)lenses for lot # l004zcx.A magnified visual inspection revealed an edge chip on (b)(4) opened lens and excess lens material on the other opened lens.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

On 10nov2022 the japan affiliate provided additional medical information.The pt reported the staining was fully healed, although blurs.The va is 1.5.The pt advised no instruction to discontinue contact lens (cl) wear or return to the clinic was given.On 15nov2022, a call was placed the to treating eye clinic and a representative provided additional information.After the visit on (b)(6) 2022, the pt returned to the clinic on (b)(6) 2022, (b)(6) 2022 and (b)(6) 2022.The representative advised nothing is noted on the pt¿s chart that the pt was allowed to return to cl wear, but advised a doctor may have advised the pt of that.The representative confirmed the ecp advised ¿full recovery with a slight sequela.¿ the va on (b)(6) 2022 was confirmed as va 1.5.The pt plans the next visit for regular exam in half a year.A medical interview was requested.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 - IRELAND; 1 technological park plassey; limerick LK130 01; EI LK13001
• Manufacturer Contact: helene aguilar ; 7500 centurion parkway; jacksonville, FL 32256 ; 9047429918
• MDR Report Key: 15284827
• MDR Text Key: 298507343
• Report Number: 1057985-2022-00061
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2022
• 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: L004ZCX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Female