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 Ulcer (1796); Headache (1880); Pain (1994); Discomfort (2330)

Event Date 02/28/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter's phone number: (b)(6).

Event Description

On 05mar2020, a patient (pt) in (b)(6) called to report being diagnosed with a corneal ulcer in the left eye (os) while wearing acuvue® oasys® brand contact lenses (cls).Pt reported experiencing discomfort on (b)(6) 2020 while wearing a lens on the fourth day of wear.Pt also reported experiencing a headache and pain in the os.Pt presented to an eye care provider (ecp) at a hospital and was diagnosed with a ¿small¿ ulcer in the os at 12:00.Pt was prescribed gatifloxacin/prednisone antibiotic eye drops to use every 4 hours until the next follow up appointment on (b)(6) 2020.Pt reported replacing lenses every 3 weeks and does not sleep in lenses.On 06mar2020, the pt was contacted and provided additional information: pt reported being seen by ecp for a follow up appointment and was advised the ulcer is improving.Pt reported the antibiotic eye drop frequency was changed to every 6 hours until the next f/u appointment on (b)(6) 2020.On 10mar2020, an email was received from the pt will additional information: pt reported seeing the treating ecp for a f/u visit on (b)(6) 2020.Pt reported the ecp advised the ¿ulcer was healed¿.On 25mar2020, the ecp at the treating hospital was contacted an additional information provided from the pt¿s medical report: ecp reported the pt was initially seen on (b)(6) 2020 for cl related discomfort.Ecp confirmed the pt was diagnosed with an os inferior corneal ulcer which was treated with medication but could not provide the location.Ecp reported pt was seen for follow up visits on (b)(6) 2020.Pt was instructed to d/c lens wear for an additional 7 days and could then return to cl wear.No additional information was received.The suspect lens was requested for return, but the product has not been received.A lot history review was performed and revealed the following: the batch record did not show any abnormalities in monomer and solution testing.All parameters tested were within specification.All sterilization requirements were successfully completed.Lot b00swvd was produced under normal conditions.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: 9883582
• MDR Text Key: 195644279
• Report Number: 1057985-2020-00026
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): Y
• Reporter Country Code: AR
• 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: Other
• Type of Report: Initial
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• 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: B00SWVD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 28