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 Scar (1793); Corneal Ulcer (1796); Neovascularization (1978); Pain (1994); Red Eye(s) (2038); Corneal Infiltrates (2231); Excessive Tear Production (2235); Discomfort (2330)

Event Date 07/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2019 an email was received from a representative in the johnson and johnson clinical research department who reported a patient (pt) was diagnosed with a peripheral corneal ulcer in the od while wearing the acuvue oasys brand contact lenses.The pt presented to a clinical research visit 5, (b)(6) 2019 without complaints or changes noted in the medical or ocular history.A slit lamp examination was performed, and the pt was diagnosed with a peripheral corneal ulcer od.The pt reported mild pain and discomfort od that began on (b)(6) 2019 and progressively worsened until the pt removed the contacts around noon that day.The pt reported removing the suspect od lens seemed to make it better.The pt denied any vision changes.On (b)(6) 2019 a call was placed to the johnson and johnson employee and additional medical information was provided.The pt was treated prophylactically with moxifloxacin.The pt was not wearing lenses at the time of the study visit.Received pt office visit on (b)(6) 2019: visit 5 dated (b)(6) 2019: slit lamp examination: od infero-temporal mid-peripheral, circular, well-circumscribed corneal infiltrate (1 mm diameter) with overlying grade 3.Epithelial staining, grade 2 limbal and bulbar injection, grade 2 nasal and temporal neovascularization.--anterior chamber was relatively quiet, 1-2 cells may have been noted.Subject reported light sensitivity in the right eye during the exam.Mild watering, no mucopurulent discharge.Assessment & plan: peripheral contact lens induced corneal ulcer, right eye.Moxifloxacin 0.5% 1 drop in the right eye three times a day for 7 days, follow up tomorrow.On (b)(6) 2019 a call was placed to the johnson and johnson employee and additional medical information was provided.The pt was seen on (b)(6) 2019 and (b)(6) 2019.A corneal scar was seen at the last visit, but it may be ¿only residual¿, healing ulcer.The employee reported the pt is ok now and the event ¿looked worse that the pt was feeling.¿ on (b)(6) 2019 additional medical information was provided: pt was seen for 1-week follow-up visit on (b)(6) 2019 for the peripheral od corneal ulcer.The pt was asymptomatic.Biomicroscopy revealed infero-temporal mid peripheral, circular, well-circumscribed, 0.5mm x 0.5 mm corneal scar with no staining; grade 2 nasal and temporal neovascularization.Remarks indicate resolved corneal ulcer od; discontinue moxifloxacin.On (b)(6) 2019 additional information was received.The clinical research physician reported the suspect lot # is unknown.The physician thinks the pt discarded the suspect od contact lens.The pt has an appointment and will check with the pt and call back and advise if the suspect lens or lot # is available.No additional medical information has been received.The lot number is unknown.It is unknown if the suspect od contact lens is available for return for evaluation.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: 8831196
• MDR Text Key: 152563855
• Report Number: 1057985-2019-00070
• 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: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• 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: UNK-PH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention