MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. - US ACUVUE OASYS®1 DAY WITH HYDRALUXE¿ TECHNOLOGY; LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number TSP

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

Patient Problems Bacterial Infection (1735); Corneal Edema (1791); Corneal Scar (1793); Corneal Ulcer (1796); Foreign Body Sensation in Eye (1869); Keratitis (1944); Red Eye(s) (2038); Blurred Vision (2137); Visual Disturbances (2140); Eye Pain (4467); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/06/2021

Event Type  Injury  

Manufacturer Narrative

The suspect os cls was discarded.

Event Description

On (b)(6) 2021 a representative at an eye care provider (ecp) in (b)(6) called to report a patient (pt) experienced os redness and foreign body sensation on (b)(6) 2021 while wearing an acuvue oasys®1 day with hydraluxe¿ technology brand contact lens (cls).The pt developed os eye pain after the os suspect cls was removed which currently continues.The pt will visit an ecp on (b)(6) 2021.On 08oct2021 the pt provided additional information.The pt reports current ¿cloudiness in white, for which cannot see at all¿.On (b)(6) 2021 the pt presented to an ecp and was diagnosed with ¿bacteria in keratitis¿.The pt was advised to discontinue cls wear.On (b)(6) 2021, on a return ecp visit, fluorometholone eye drops, vegamox eye drops and tarvid eye ointment were prescribed.A medical interview was requested for additional medical information.On (b)(6) 2021 an ecp at the pts treating eye clinic provided additional information.Diagnosis: probably bacterial keratitis.Seriousness: the pt was not able to see considerably, the event was considered serious.On the return visit (date not provided) some improvement was observed since the initial visit.A return visit is planned (no date was provided).On 13oct2021 the pt provided additional information.The pt advised the redness is better.The pt can also see better than before.On (b)(6) 2021 the pt returned for a follow-up visit and was instructed to return on (b)(6) 2021.Hyaluronic acid eye drops 0.1% qid was prescribed.The pt continues to use the previously prescribed medications.No additional medical information has been received.The os lot number is unknown.The suspect os cls was discarded.No additional evaluation 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 additional medical information.The pt went to the (b)(6) clinic on (b)(6) 2021.The pt can wear a contact lens and the pain is resolved, but the ¿white fogginess¿ remains with no improvement in over a month.On (b)(6) 2021 the pt has an appointment for ¿surgery scraping the surface.¿ the pt will return on (b)(6) 2021 for a follow-up (fu) appointment with an additional fu appointment on (b)(6)2021.A new prescription for rinderon-a (betamethasone sodium phosphate) was provided.On 26nov2021 additional medical information was provided by a representative at the (b)(6)clinic.On (b)(6) 2021 the pt returned to the clinic.The opacity remained.On (b)(6) 2021 the ¿surface cornea is to be scraped to enhance regeneration.¿ the pt was also instructed to use rinderon eye drops along with the previously prescribed eye drops until (b)(6) 2021.The medical record noted that keratitis and cloudiness remained.The pt has fu appointments on (b)(6) 2021.On (b)(6) 2021 the pt reported there is no change in the condition of the eye.The pt is using the eye drops as prescribed and hopes the cloudiness resolves after the eye surgery and the healing process.No additional medical information was provided.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

On 15nov2021 additional medical information was received from the patient¿s (pt) treating eye care provider.Date of visit: (b)(6) 2021 to the eye clinic.The pt presents with complaints of os eye pain.Diagnosis: corneal ulcer os at upper os, 1 mm; observation: ulcer + between limbus cornea and the center of cornea.Infectious; culture obtained.Va is considered affected.Treatment: vegamox ophthalmic solution; flumetholon ophthalmic suspension 0.1 % and tarvid eye ointment the pt was instructed to discontinue contact lens (cls) wear until recovery date of visit: (b)(6) 2021 observation: ulcer somewhat improved, edema increased; symptoms improved outcome: unchanging va: not measured treatment: hyaluronic acid eye drops 0.1% added pt to return in 1 week.Date of visit: (b)(6) 2021 observation: corneal opacity; outcome: resolving va: corrected: 1.0 os; naked vision: 0.09 os treatment: continue using eye drops; continue with no cls wear return in 1 month no additional medical information has been received.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

On 22dec2021 a call was placed to the patient¿s (pt) treating eye care provider (ecp) and a representative provided additional information.On (b)(6) 2021 the pt had a corneal ulcer curettage.Eye drops of vegamox qid and sodium hyaluronate qid, and tarvid eye ointment were prescribed.The pt was advised to discontinue rinderon eye drops.On (b)(6) 2021 the pt returned to the eye clinic for follow-up.The pt reported the eye improved though had blurry vision.The ecp instructed the pt to continue using the prescribed eye drop.The eye ointment was discontinued.The pt has a fu visit for (b)(6) 2022.The os va was ¿a little under 1.2¿.No additional medical information was provided.On 25dec2021 a call was placed to the pt who provided additional information.The pt will return for the (b)(6) 2022 ecp visit.The pt reports there is no improvement.If the vision doesn¿t improve the pt may agree to laser surgery.An additional fu call will be placed to the pt after the (b)(6) 2022 ecp visit.No additional medical information was provided.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

On 02feb2022, a representative at the patient¿s (pt) eye care provider's (ecp) office provided additional information.On (b)(6) 2022, the pt returned to the office with chief complaint of work is affected due to difficulty in seeing.An ecp advised ¿it would be better to take a surgery to scrape the cornea.¿ the eyedrops treatment was discontinued.Os naked vision was 0.1 and corrected vision was va 0.9.No additional medical information was provided.On (b)(6) 2022, the pt reported no change in the condition of the eye.The pt felt cloudiness improved only a little.The pt has an eye appointment on (b)(6) 2022 with clinic for eye surgery.On (b)(6) 2022, the pt reported no change in the current eye condition, os cloudiness remains.On (b)(6) 2022, the pt attended a visit to the clinic and an os eye exam was performed.The surgery was scheduled about a month later.The pt thinks the laser surgery is on (b)(6) 2022.After the surgery the pt will attend follow-up visits to the clinic on saturday, sunday, wednesday, and the next saturday.The pt confirmed the name of the surgery is ¿photo-therapeutic keratectomy (ptk).¿ on (b)(6) 2022, a call was placed to the eye clinic for the up-coming laser surgery.A medical interview was requested.No additional medical information was provided.On (b)(6) 2022, the additional medical information was provided from the pt.The surgery is scheduled for on (b)(6) 2022.The ecp advised the pt that ¿full removal would be impossible as it (opacity) reached the deep layer.¿ the pt is currently applying unknown ¿eyedrops every day to make the opacity as small and thin as possible.¿ the pt has another visit at the clinic before the surgery.No additional medical information has been received.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

On 26mar2022 a call was placed to the patient (pt) and additional information was provided.The pt advised the eye surgery scheduled on (b)(6) 2022 was cancelled.The pt reported ¿there was a risk in it because whole cornea would be scraped.¿ the pt is ¿using medication for 2-3 months¿ and will see how it goes.The name of the medication was not provided.The pt will return to the eye clinic in (b)(6) 2022.No additional information was provided.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

On apr.16, 2022, a call was received from the patient (pt) and additional information was provided.The pt advised there has been no significant improvement in the eye.The pt stated, ¿because of deep location of the cloudiness, the cornea would become thin if scraped and it would be the matter of how it can naturally heal using eye drops.¿ the pt will use eye drops ¿for a while returning to the clinic monthly,¿ and plans the next clinic visit on (b)(6) 2022.No additional information was provided.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

On 06may2022, additional information was provided.Medical documents from the patient¿s (pt) treating eye clinic were received.The following is a summary of the information provided: the adverse event: corneal opacity os seriousness: non-serious.Causal relationship with cl: unknown.Observation at the initial visit: on the illustration, a black dot was indicated on upper os between corneal limbal and center.Outcome: not recovered.Visit date: (b)(6) 2022.Chief complaint: reduction in visual acuity os.Diagnosis: corneal opacity os.Culture: not conducted.Focal site: center cornea os.Size: 1 mm x 1 mm.Observation: opacity in the center cornea os, indication for ptk.Va affected: affected.Corrected va: 0.9 os.Naked eye va: 0.06 os.Treatment: none.(continue the use of previously prescribed eye drops) no instruction to discontinue cl wear was made.A return visit in a month was instructed.(b)(6) 2022 visit: outcome: unchanging.Observation: opacity, mild warpage.Va: measured.Corrected va: 1.0p os; naked eye va: 0.06 os.Treatment: betamethasone sodium phosphate pf ophthalmic and otorhinologic solution 0.1% bid.No instruction to discontinue cl wear was made.A return visit in a month was instructed.(b)(6) 2022 visit: outcome: unchanging, spk.Observation: opacity, spk.Va: measured.Corrected va: 0.9 os; naked eye va: 0.06 os.Treatment: diquas eye drops 6id was added to betamethasone sodium phosphate pf.Ophthalmic and otorhinologic solution 0.1% no instruction to discontinue cl wear was made.No return visit was instructed.On 11may2022, medical receipts were received from the pt for dates of visit to the eye clinic and pharmacy as follows: eye clinic: dates of visit: (b)(6) 2021 and (b)(6) 2022.Pharmacy (medication information was not provided): dates of dispensing: (b)(6) 2021 and (b)(6) 2022.No additional information has been received.No additional medical information is expected.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

On 04oct2022, the patient (pt) provided additional information.The pt currently does not feel muddiness or cloudiness in the eye getting better.The pt returned to the eye clinic in (b)(6) 2022 and was advised that in the doctor¿s view that ¿no dramatic recovery would be expected after the surgery.¿ the pt will have to wait for ¿natural recovery using eye drops at this stage as unevenness on the surface and the cloudiness at the back cannot be taken out.¿ the pt plans a return visit in (b)(6) 2022.The pt ¿got enough eye drops (name and frequency of the drops were not provided) prescribed to use until then.¿ the pt agreed to follow-up call in (b)(6) 2022.No additional information was provided.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

On 22dec2022, the patient (pt) provided additional information: the pt still reports ¿cloudiness in the eye currently.¿ no improvement in ¿muddiness.¿ the pt will go to the eye clinic on (b)(6) 2022.On 28dec2022, the pt provided additional information: the pt went to the eye clinic on (b)(6) 2022 and reported the doctor explained cloudiness remained in the eye, but ¿was getting thin compared to (b)(6) 2022.¿ the pt wants to continue ¿medicine treatment¿ aiming at natural healing rather than surgery.The pt has a return appointment in (b)(6) 2023.No additional medical information was provided.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: ACUVUE OASYS®1 DAY WITH HYDRALUXE¿ TECHNOLOGY
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. - US; 7500 centurion parkway; jacksonville FL 32256
• Manufacturer Contact: richard holmes ; 7500 centurion parkway; jacksonville, FL 32256 ; 9548020487
• MDR Report Key: 12712009
• MDR Text Key: 278864234
• Report Number: 1057985-2021-00164
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K042275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: TSP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Disability
• Patient Sex: Male