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)

Event Date 12/07/2019

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" od while wearing an acuvue® oasys® brand contact lens.The pt wore a new contact lens on (b)(6) 2019 and experienced od redness within a few hours.The pt reported visiting an eye care provider (ecp) and was diagnosed with od ¿bacterial conjunctivitis¿.The pt was prescribed ciprofloxacin eye drops q4h for 7 days and contact lens rest for 7 days for the od.The pt reported returning to the ecp (unspecified date) and was cleared to return to contact lens wear on (b)(6) 2019.The pt had no issues with the os.The pt reported using opti-free solution to clean lenses.On (b)(6) 2019, additional information was received from the pt: the pt reported initial confusion when reporting the date of the event.The pt wore a new contact lens on (b)(6) 2019 and experienced od redness (b)(6) 2019.The pt reported visiting a family member who is a doctor who advised the pt to use the same treatment prescribed by the ecp for a previous event.The pt reported restarting sophixin (cipro/dexamethasone) every 4 hours for 5 days, hyabak lubricating eye drops every 6 hours, baby shampoo eye washes.The pt was on contact lens rest until (b)(6) 2019.No additional information was received.This event is being reported as a worst-case event as the diagnosis and treatment were unable to be verified.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 l003c3p was produced under normal conditions.The suspect od contact lens was requested for return for evaluation but has not yet been received.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

Four sealed blister packages were received for evaluation for lot number l003c3p.Two additional lenses were received in an opened lens case.A visual exam was performed for the two open lenses which revealed no abnormalities.Both opened lenses met company standards for base curve and center thickness.One opened lens measured out of specification for power and one opened lens measured out of specification for diameter.Because the product was returned opened, it is not known what external influences may have contributed to the out of specification measurements.The four sealed blisters met all parameters specification including sphere minus power and diameter.The solution ph and conductivity for the four sealed lenses measured within specification.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: 9588811
• MDR Text Key: 189458574
• Report Number: 9617710-2020-00004
• 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: 04/16/2020

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: 09/01/2022
• Device Catalogue Number: PH
• Device Lot Number: L003C3P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Initial Date Manufacturer Received: 12/27/2019
• Initial Date FDA Received: 01/14/2020
• Supplement Dates Manufacturer Received: 04/14/2020
• Supplement Dates FDA Received: 04/16/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 27 YR