MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE - IRELAND ACUVUE OASYS®1 DAY WITH HYDRALUXE¿ TECHNOLOGY; LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number TSP

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

Patient Problems Corneal Ulcer (1796); Dry Eye(s) (1814); Red Eye(s) (2038); Eye Pain (4467)

Event Date 10/22/2021

Event Type  Injury  

Event Description

On 26-nov-2021 an eye care provider (ecp) in the (b)(6) called to report a patient (pt) went to the hospital and was diagnosed with 2 eye ulcers while wearing the acuvue® oasys 1-day with hydraluxe® technology brand contact lens cls.The exact date is unknown.No additional information was provided.On 02-dec-2021 the ecp reported the pt still wants to wear the lenses, but the ecp doesn¿t recommend that for the pt.The pt doesn¿t want to wear the lenses from the suspect lot number related to this event.On 15-dec-2021 additional medical information was provided by a representative at the pts reporting ecp office.The pt was seen at the hospital on (b)(6) 2021 after symptoms of redness and pain ou presented.The pt was diagnosed with corneal ulcer ou.The corneas were scrapped and the sample was sent to the lab for testing.The ou corneal ulcers were not infectious.The pt was prescribed oftaquix 1 drop hourly in both eyes until (b)(6) 2021.The pt was also prescribed an unknown eye drop for dry eye and advised to discontinue cls wear.The pts eyes are currently fine with no permanent damage or loss of visual acuity.The manager will discuss release of additional medical information from the hospital treatment with the pt and advise if any additional information will be provided.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 5270910109 was produced under normal conditions.The suspect cls for the od was discarded.No additional evaluation can be conducted.This report is for the pts od event.The event for the pts os will be provided in a separate report.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: ACUVUE OASYS®1 DAY WITH HYDRALUXE¿ TECHNOLOGY
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE - IRELAND; 1 technological park plassey; limerick LK130 01; EI LK13001
• Manufacturer Contact: helene aguilar ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433835
• MDR Report Key: 13027646
• MDR Text Key: 286052802
• Report Number: 1057985-2021-00178
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K042275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: TSP
• Device Lot Number: 5270910109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2021
• 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): Required Intervention; Other