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 Conjunctivitis (1784); Corneal Scar (1793); Dry Eye(s) (1814); Eye Injury (1845); Foreign Body Sensation in Eye (1869); Local Reaction (2035); Eye Pain (4467)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Suspect product discarded.

Event Description

On (b)(6) 2021 a patient¿s (pt) family member reported the pt had ¿a problem¿ with unknown acuvue® brand contact lenses (cl) for over a year.The pt visited an ophthalmologist for treatment.On (b)(6) 2021 the pt was contacted and reported at the end of 2019 unknown acuvue® brand cls ¿hurt¿ both eyes (ou).The eyes were swollen, dry, and irritated.The pt visited an eye care provider (ecp) and reported a diagnosis of ¿viral conjunctivitis¿ due to ¿scratching¿ the eyes.The pt was prescribed an anti-inflammatory, lubricating eye drops, and an eye drop for pain, to use every hour for 3 weeks.The pt returned to the ecp after treatment ended and ou were ¿not healed¿ and the ¿diopter kept changing.¿ the prescribed medication was continued for 3 months and no cl wear due to ¿scarring¿ caused by the ¿viral conjunctivitis.¿ the pt is currently wearing glasses.The pt was unable to provide any further information at that time.On (b)(6) 2021 an email was received from the pt reporting the event occurred in 2019.The pt was advised by treating ecps that the cls were causing ¿micro scratches.¿ the pt reported ¿over time, the lenses were causing deeper scratches, until it turned into a conjunctivitis¿ and was unable to return to cl wear.The pt reported experiencing ¿constant pain.¿ after week 1 of treatment, ou were improving, but ¿the difficulty to see seemed to be much worse than before.¿ the pt reported improvement by week 3, reduced eye drops use, and only used lubricating drops for dry eyes.The pt visited an ecp who advised the eyes had ¿micro-fissures.¿ the pt was prescribed an unknown eye drop for 3 months.The pt returned for a follow-up after the treatment ended and was informed the ¿micro-fissures¿ remained and treatment would need to continue (unspecified).The pt never returned to the ecp and reported the ¿vision remains unstable during some periods of the day.¿ prescriptions from 2 treating clinics: clinic #1, not dated: tobracin eye drops os every 3 hours for 7 days; ster md 1 gtt os every 6 hours for 7 days; ecofilm lubricating drops every hour.Clinic #2, dated (b)(6) 2019, fresh tears; optive.On (b)(6) 2021 a representative from clinic #1 advised the pt visited on (b)(6) 2019, (b)(6) 2019, and (b)(6) 2019.The diagnosis was unable to be confirmed.On (b)(6) 2021 the clinic #2 was contacted with no additional information provided.On (b)(6) 2021 the pt confirmed wearing acuvue® oasys® brand cl at the time of the event.The pt reported a visit to clinic #2 on (b)(6) 2019.The pt had a consultation for a refraction exam (unknown date), but the ecp was unable to perform an eye exam.Clinic #2 ecp (unknown date) instructed the pt to continue using lubricating drops and advised the cls had been ¿hurting¿ the ou, causing ¿conjunctivitis.¿ the pt agreed to request the diagnosis from clinic #2.The pt reported visiting another ecp (clinic #3) in 2020 who advised ou were not healed and to continue using lubricating drops.The pt reported a 15-day replacement schedule, does not sleep in cls, and uses renu solution to clean cls.On (b)(6) 2021 the clinic #3 was contacted with no additional information provided.On (b)(6) 2021 received insurance statement with a list of ecp visit dates: ecp consult on (b)(6) 2019; ecp consult on (b)(6) 2019; ecp consult on (b)(6) 2019 ¿ conjunctivitis; ecp consult on (b)(6) 2019; ecp consult on (b)(6) 2019; ecp consult on (b)(6) 2019; ecp consult on (b)(6) 2019.No additional medical information has been received after multiple attempts to the pts treating ecp offices.This event is being reported as a worst-case event as the diagnosis and treatment were unable to be verified by the treating ecp.The lot number is unknown.The suspect od cls was discarded.No further investigation can be conducted.This report is for the od event.The report for the pts os event will be submitted in a separate submission.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 32256
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433647
• MDR Report Key: 11813296
• MDR Text Key: 265161569
• Report Number: 1057985-2021-00131
• 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: consumer,foreign,health profe
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: PH
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2021
• 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): Other; Required Intervention
• Patient Age: 19 YR