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 Bacterial Infection (1735); Corneal Ulcer (1796); Vitreous Floaters (1866); Foreign Body Sensation in Eye (1869); Hypoxia (1918); Keratitis (1944)

Event Date 12/10/2020

Event Type  Injury  

Manufacturer Narrative

Suspect discarded by the patient.

Event Description

On 15jan2021 a patient (pt) called to report a diagnosis of os corneal ulcer while wearing the acuvue® oasys with hydraclear® plus brand contact lenses (cls).The pt reported sleeping in the lenses for ¿a while¿ and experienced os foreign body sensation.The pt went to an urgent care, prescribed cipro, and referred to an ophthalmologist.The pt reported the symptoms began (b)(6) 2020 and went to ophthalmologist on (b)(6) 2020.Per the pts discharge papers, the pt was diagnosed with an os corneal ulcer, location of ulcer not provided.The pt was prescribed ciprofloxacin five times a day or 2 drops every 4 hours for 5 days; white spot floaters; scar superiorly, old ulcer; infection of bacterial; inflammation of the cornea over wear of cls; hypoxia, no lens wear for the period of treatment; clear to use cls after treatment; switched to biofinity cls.The pt was reported using biofinity lenses in the past, sleeping in lenses and never had an issue with the lenses.Pt is currently using lenses and the ulcer and scar healed well.The pt has a follow-up appointment in a year.The pt agreed to sign a medical release form at the treating ophthalmologist office to provide additional information.On 19jan2021 a call was placed to the pts treating ophthalmologist office and a representative advised the pt must sign a medical release form to allow the release of any medical information.No additional information was provided.On 09feb2021 a call was placed to the pt to determine what cls brand the pt was wearing at the time of the ¿superior scar, old ulcer¿ provided from the discharge papers.The pt reported there was no previous ulcer or scar.The pt began wearing the acuvue® oasys® brand cls in (b)(6) 2020 and discontinued wear in (b)(6) 2020.The only event the pt experienced was the os corneal ulcer event in (b)(6) 2020 while wearing the acuvue® oasys® brand cls.The pt wore the air optix brand cls prior to acuvue® oasys® brand cls wear, not biofinity as previously reported.The pt is currently wearing air optix cls.The pt refused to release any medical information from the treating ophthalmologist.No additional medical information was provided.No additional medical information is expected.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 b00txbd was produced under normal conditions.The suspect os contact lens was discarded.No additional evaluation can be conducted.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 32256
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433647
• MDR Report Key: 11308924
• MDR Text Key: 238344228
• Report Number: 1057985-2021-00110
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• 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: B00TXBD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2020
• 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
• Patient Age: 41 YR