MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE - IRELAND ACUVUE OASYS; LENSES, SOFT CONTACT, EXTENDED WEAR

Catalog Number PH

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

Patient Problems Bacterial Infection (1735); Foreign Body Sensation in Eye (1869); Headache (1880); Keratitis (1944); Red Eye(s) (2038)

Event Date 12/01/2020

Event Type  Injury  

Event Description

On (b)(6) 2020, a patient (pt) in (b)(6) reported red eyes and burning while wearing the acuvue® oasys® brand contact lenses (cls).On (b)(6) 2020, the pt provided additional medical information.The pt reported redness and burning sensation immediately upon inserting the cls from a sealed blister package last week.The symptoms continued after the suspect cls were removed.The pt did not visit an eye care provider (ecp) nor use any medications at that time.The pt did not trial fit for the cls with an ecp.On (b)(6) 2021, the pt provided additional medical information.The pt inserted additional cls from the same package and lot number and experienced a burning sensation, headache, and redness while wearing the suspect cls and after removal.On (b)(6) 2021, the pt visited the emergency hospital and was diagnosed with ¿infection caused by the use of cl.¿ the ecp instructed the pt to discontinue cl wear for 15 days and prescribed vigadexa 1 drop every 4 hours for 7 days and hyabak 1 drop every 4 hours if discomfort persists.The pt reported the od is worse than the os.No contact information is available for the treating ecp.On (b)(6) 2021, the pt provided additional medical information.The pt reported the diagnosis on the medical certificate is icd code (b)(4) other superficial keratitis without conjunctivitis.The pt is unsure if it was an infection or inflammation.The ou irritation and burning sensation is better since starting treatment.No return visit has been scheduled with the ecp, as the pt was advised to return if symptoms continued.The pt agreed to provide the medical certificate via email.On 12jan2021, an email was received from the pt with ecp note and receipts.Ecp note dated 0(b)(6) 2021: the pt ¿did not adapt with oasys lenses, loose lenses caused keratitis.The same is not wearing cl and undergoing treatment to heal the keratitis.¿ rescription dated (b)(6) 2021: adaptis fresh, every 6 hrs; cylocort/vigadexa, 1 gtt every 4 hrs for 7 days; opti-free puremoist to clean cls.Work excuse note for 1 day off work with icd code (b)(4).On 12jan2021, a call was placed to the treating ecp who reported the pt is being treated with vigadexa for bacterial keratitis.The ecp instructed the pt to return for follow-up after the 7-day prescribed treatment concluded.The ecp advised the pt was not fit for cls, and the cls were a poor fit for the pt.The pt was also not using a ¿good solution¿ to clean the cls.Additional attempts have been made to contact the pt for additional medical information, but no further information has 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 l00484m was produced under normal conditions.One opened cl case was received which contained two cls for lot # l00484m.The parameters of the lenses were measured, and a visual inspection was performed.The lenses met company standards for base curve, power, center thickness, and diameter.No visual attributes were observed.This report is for the pt¿s os event.The report for the pts od event will be filed in a separate report.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 - IRELAND; 1 technological park plassey; limerick LK130 01; EI LK13001
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433647
• MDR Report Key: 11279423
• MDR Text Key: 233324080
• Report Number: 9617710-2021-00107
• 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: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: L00484M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/12/2021
• Initial Date FDA Received: 02/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/29/2020
• 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
• Patient Outcome(s): Other; Required Intervention