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

Catalog Number CYP

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

Patient Problems Corneal Scar (1793); Corneal Ulcer (1796); Foreign Body Sensation in Eye (1869); Local Reaction (2035); Red Eye(s) (2038); Corneal Infiltrates (2231); Excessive Tear Production (2235); Eye Infections (4466); Eye Pain (4467)

Event Date 04/12/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, a patient¿s (pt) family member reported the pt had a ¿corneal ulcer and herpes¿ while wearing an acuvue® oasys for astigmatism brand contact lens (cl).The pt was prescribed lunah, regencel cream and acyclovir.No additional information was provided.On (b)(6) 2022 additional information was provided by the pt¿s family member.In (b)(6) 2022, the pt experienced left eye (os) pain and swelling the morning after the removal of the suspect cl.The pt went to an emergency room and was diagnosed with a corneal ulcer and was prescribed lubricating drops, lunah (frequency not provided) and regencel cream once daily at bedtime.The pt visited a second eye care professional (ecp), (date of visit not provided) who prescribed acyclovir for 10 days.The ecp advised the ¿symptoms may be related to herpes¿ and advised the pt to continue the lunah and regencel cream.The pt¿s eye pain improved 5 days after initiating treatment with the acyclovir.The pt has been released to return to cl wear, but the pt has not yet returned to cl wear.The pt has a scar on the os and the family member is not certain if the pt has a return visit to the ecp.The pt has a 20-day replacement schedule and reports daily cl wear.The family member reported the pt uses ultrasept to clean the lenses.The date of the event is reported as apr2022.Multiple calls were placed to contact the pt¿s family member and treating ecp for additional information with no success.No additional medical information 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 b00wgkc was produced under normal conditions.The os suspect cl was discarded.No additional evaluation can be conducted.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

Suspect product was discarded.

Manufacturer Narrative

On 20jun2022, a call was placed to the patient (pt) and additional information was provided.The pt described ¿first-time symptoms¿ as discomfort, burning sensation and foreign body sensation.The pt visited an emergency room on (b)(6) 2022 and was diagnosed with an os corneal ulcer (peripheral around 2 o¿clock).The pt was prescribed vigamox, lunah lubricating drops every 3 hours until the return visit scheduled in 3 days, and regencel for use at night for 10 days.The pt visited an eye care professional (ecp) ¿after a few days¿ and advised of a potential diagnosis of herpes.The ecp continued treatment of vigamox, lunah lubricating drops 3 times daily for 7 days and regencel, as previously prescribed.The ecp also prescribed acyclovir, daily for 15 days.The pt had a return visit with the ecp on (b)(6) 2022 and was allowed to return to contact lens (cl) wear.The pt is scheduled for a routine ecp visit in 6 months.The pt was advised to discontinue cl wear for any discomfort and return to the ecp, if needed.The pt stated the ecp believes the corneal ulcer was due to the herpes diagnosis.The pt advised this is the first diagnosis of herpes.The date of event is updated from apr2022 to 13apr2022.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

On 13jul2022, additional information was received from the pt¿s family member.Eye care professional (ecp) note dated (b)(6) 2022: pt presented on (b)(6) 2022 complaining of os eye pain, associated with hyperemia and tearing.Pt reports symptoms began 2 days ago.Pt was previously diagnosed with os corneal ulcer by an ophthalmologist and is using vigamox every 3 hours, regencel once nightly and relates an improvement in pain.Examination: visual acuity 20/20, topical eyelashes, conjunctiva hyperemia 1/2+, corneal lesion approximately 1mm in the upper region with discrete infiltrate, significant decrease in sensitivity, dendritic lesion with the presence of end bulbs.Diagnosis: os corneal ulcer, suggestive of ocular herpes.Treatment: maintain use of vigamox every 3 hours and regencel nightly as previously prescribed.Prescribed eye lash hygiene, acyclovir 2g daily for 20 days, and return visit on saturday.Ecp note dated (b)(6) 2022: pt returned for follow-up with improvement of symptoms without complaints.The va in the os is 20/20.Examination: cornea discrete superior paracentral scarring opacity less than 1mm without infiltrates or activity os (does not stain with fluoresceine).Treatment: maintain lubricating drops every 4 hours, cleansing of lashes, and complete treatment with acyclovir 20 days, 2g daily.Request retinal mapping, follow up in 30 days.Retinal mapping exam dated (b)(6) 2022: high myope, normal exam, suggest yearly exam.Ecp note dated (b)(6) 2022: pt was seen on (b)(6) 2022.Exam os: oily topical lashes, clear conjunctiva, cornea discrete superior paracentral scarring opacity less than 1mm without infiltrates or activity (does not stain with fluoresceine).Diagnosis: ocular herpes.Conclusion: pt able to return to normal daily activities and with the eyes, being advised of possible complications.The event date was updated to (b)(6) 2022.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: ACUVUE® OASYS® FOR ASTIGMATISM
• Type of Device: LENSES, SOFT CONTACT, EXTENDED WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. - US; 7500 centurion parkway; jacksonville FL 32256
• Manufacturer Contact: helene aguilar ; 7500 centurion parkway; jacksonville, FL 32256 ; 9047429918
• MDR Report Key: 14681211
• MDR Text Key: 294134635
• Report Number: 1057985-2022-00038
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: CYP
• Device Lot Number: B00WGKC
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2020
• 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
• Treatment: ULTRASEPT
• Patient Outcome(s): Required Intervention; Other; Disability
• Patient Age: 31 YR
• Patient Sex: Female