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 Bacterial Infection (1735); Corneal Scar (1793); Corneal Ulcer (1796); Foreign Body Sensation in Eye (1869); Headache (1880); Red Eye(s) (2038); Eye Pain (4467)

Event Date 02/01/2022

Event Type  Injury  

Manufacturer Narrative

Os suspect contact lens discarded.

Event Description

On (b)(6) 2022 a patient (pt) in (b)(6) called to report an os ¿infection in the cornea¿ while wearing the acuvue® oasys 1-day with hydraluxe ¿ brand contact lens (cl).The pt reported headache, irritation, redness and advised the lens immediately ¿hurt the eyes¿ on insertion with 7 os cls in (b)(6) 2022.The pt reported the symptoms persisted after removal of the cl.The pt went to an eye care provider (ecp) who provided an unknown eye drop.The pt has a follow-up appointment on (b)(6) 2022.On 10feb2022 a call was placed to the pt¿s treating ecp.Ecp reported the pt was diagnosed with an os infectious corneal ulcer, superior aspect of cornea on (b)(6) 2022.The ecp advised the pt is still under treatment and the os is sensitive due to an os scar.The pt was prescribed sacoba every 3 hours for 7 days and now is using it qid.The pt was also prescribed cetrolac (trometamol) qid and hyabak qid.The ecp is not sure what caused the event, perhaps overuse of the lenses.The pt was advised to suspend cl wear for 15 days, until next visit.On 10feb2022 the pt provided additional information.The pt reported discomfort immediately on insertion of new lenses.The pt was only prescribed medication for the os only.The pt didn¿t have the names of the medication provided at the time of the call but advised there was an ointment prescribed for the os at bedtime.The pt advised there is os scarring and the os is not completely healed.The pt reported the os is a little red now and by the end of the day the pt experiences a headache.The pt takes dipirona 250 mg for headache after work.The pt is currently wearing glasses.A follow-up appointment is scheduled for (b)(6) 2022.The pt reported a replacement schedule of 1 to 2 days and used renu to disinfect the lenses.On 17feb2022 the pt provided additional information.The pt had a follow-up visit with the ecp yesterday, (b)(6) 2022.The pt reported the corneal ulcer is not completely healed.The pt was advised to continue use of hyabak, sacoba qid and maxiflox-d ointment (ciprofloxacin/dexamethasone) nightly.The pt will have an additional follow-up visit with the ecp, date is unknown.The lot number of the suspect product is unknown at this time; pt agreed to provide by email.On 03mar2022 the pt provided additional information.Images of boxes of eye drops: maxiflox-d use at night, facoba, adaptis every 4 hrs., optve 4x daily.Image of 2 boxes of 1-day avo with hydraluxe.Image with lot# 5649920104.Image of bottle of renu solution.Prescription dated feb 22, 2022 for hyabak 1gtt os 4x daily.Work excuse note dated (b)(6) 2022 with icd code h16.0 corneal ulcer, pt not able to work from (b)(6) 2022.On 03mar2022 the pt provided additional information.The pt stated the os is currently better.Currently the pt is only using the hyabak lubricating drops, ¿continuous use¿, until return visit in 30 days.No appointment date is scheduled at this time.No additional medical information has 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 5373080104 was produced under normal conditions.The suspect os cl 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®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: 13690587
• MDR Text Key: 291395564
• Report Number: 1057985-2022-00018
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K042275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• 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: 5649920104
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2020
• 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
• Treatment: RENU SOLUTION
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Female