MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ 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); Conjunctivitis (1784); Red Eye(s) (2038); Burning Sensation (2146); Discharge (2225)

Event Date 09/30/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

On (b)(6) 2019, a patient (pt) in (b)(6) reported a diagnosis of bacterial conjunctivitis in both eyes (ou) while wearing acuvue® oasys® brand contact lenses (cl).The pt experienced burning sensation, redness, and discharge ou on (b)(6) 2019 after one day of wear with 2 cls.The pt visited an eye care provider (ecp) and was diagnosed with bacterial conjunctivitis ou.The pt was prescribed tobra corte eye drop qid for 10 days.The pt reported daily wear with a replacement schedule of 20-30 days, but sometimes sleeps in cls.No further information was provided.On (b)(6) 2019, the pt was contacted and reported visiting the ecp on (b)(6) 2019 and was advised to return for follow-up if symptoms worsened.The pt has not returned to the ecp.The pt ¿thought¿ the eyes were better and inserted a new pair of cls, and symptoms worsened.The pt is currently using eye drops previously prescribed.The pt used opti-free solution to disinfect cls.No further information was provided.On (b)(6) 2019, the pt was contacted and reported not returning to the ecp for follow-up since the eyes were ¿ok.¿ the pt has successfully returned to cl wear.No further information was provided.Multiple attempts were made to contact the treating ecp for additional medical information.No additional information has been received.This report is for the pt's os event.The event for the od will be submitted in a separate report.The suspect contact lenses were requested for evaluation but have not yet 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 l003k1x was produced under normal conditions.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

On (b)(6) 2020, an email was received from the patient (pt) with a note from the eye care provider (ecp) dated on (b)(6) 2020, which stated: "pt is able to wear contact lenses." no further information was received.One opened contact lens case was received from the pt, which contained two lenses for lot#: l003k1x.The parameters of the lenses were measured, and a visual inspection was performed.The visual inspection revealed a surface tear and surface mark on lens# 1 and a surface mark on lens# 2.The lenses met company standards for power, base curve, center thickness, and diameter.This report is for the pts os event.The event for the od will be submitted in a separate report.If any further relevant information is received, a supplemental report will be filed.Section h - 6: code 10 - testing of actual/suspected device.

• Brand Name: ACUVUE OASYS
• Type of Device: LENSES, SOFT CONTACT, EXTENDED WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND; one technological park plassey; limerick ; EI
• MDR Report Key: 9285587
• MDR Text Key: 183373553
• Report Number: 9617710-2019-00045
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): Y
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 02/18/2020

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 Expiration Date: 04/01/2023
• Device Catalogue Number: PH
• Device Lot Number: L003K1X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Initial Date Manufacturer Received: 10/16/2019
• Initial Date FDA Received: 11/06/2019
• Supplement Dates Manufacturer Received: 01/27/2020
• Supplement Dates FDA Received: 02/18/2020
• Patient Sequence Number: 1
• Treatment: OPTI-FREE SOLUTION
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 37 YR