MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ US ACUVUE OASYS FOR PRESBYOPIA; LENSES, SOFT CONTACT, EXTENDED WEAR

Catalog Number ALP

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

Patient Problems Corneal Pannus (1447); Bacterial Infection (1735); Corneal Decompensation (1790); Corneal Scar (1793); Corneal Ulcer (1796); Pain (1994)

Event Date 12/10/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Adverse event without identified device or use problem.

Event Description

On 27aug2019 a letter was received which advised the patient ¿(pt) sustained injuries due to the use of acuvue oasis¿ on (b)(6) 2018.No additional medical or product information was provided.On 21oct2019 the pt's medical records were received with additional medical information.The letter also confirmed the pt was wearing acuvue® oasys® for presbyopia brand contact lenses.See the detailed medical record information in the attachment for additional medical information.It is unknown if the suspect od contact lens is available for return for evaluation.This report is for the pt¿s od event.The event for the pts os event will be provided in a separate report.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 b00qwn1 was produced under normal conditions.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: ACUVUE OASYS FOR PRESBYOPIA
• 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: 9323160
• MDR Text Key: 185034321
• Report Number: 1057985-2019-00121
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2023
• Device Catalogue Number: ALP
• Device Lot Number: B00QWN1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2018
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 53 YR