MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE - IRELAND ACUVUE® OASYS® FOR ASTIGMATISM; LENSES, SOFT CONTACT, EXTENDED WEAR

Catalog Number CYP

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

Patient Problems Corneal Ulcer (1796); Dry Eye(s) (1814); Foreign Body Sensation in Eye (1869); Keratitis (1944); Local Reaction (2035); Blurred Vision (2137); Visual Disturbances (2140); Excessive Tear Production (2235); Eye Infections (4466)

Event Date 01/25/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, a patient (pt) in the united states reported irritation during and after wearing an acuvue® oasys® for astigmatism brand contact lens (cl).The pt reported this occurred after a week of wear (affected eye not provided) sometime in january 2023 (specific date not provided).The irritation ¿takes a little longer to resolve¿ and the pt ended up not wearing a cl for ¿a while.¿ the pt went to an eye care professional (ecp) on (b)(6) 2023 and was diagnosed with an eye infection ("allergic to the bacteria in my eye"), ulcers and irritation.The pt was prescribed doxycycline monohydrate by mouth (po) 100mg twice a day (bid) for 14 days and neo-poly-dex 1 drop three times a day (tid) for 7 days with no cl wear.The pt was also prescribed systane dry eye relief eye drops q1h and systane ointment at night.The pt also reported symptoms of eye swelling, ¿feels like rocks in my eyes,¿ photophobia, tearing at night, inflammation, blurry vision and is unable to see well with eyeglasses.The pt reported having very dry eyes and was advised the issues were not because of the cls due to over wearing cls.The pt reports daily cl wear with a 2-week replacement schedule.The pt has a follow up visit with the ecp ¿soon.¿ on (b)(6) 2023, the pt¿s treating ecp provided additional information.The ecp stated the pt has a hypersensitivity to the ¿staph bacteria on the eyelids,¿ is sleeping in cls and is over wearing cls.The pt was seen on (b)(6) 2023, diagnosed with 3+ superficial punctate keratitis (spk) and multiple ulcers around left eye (os) limbus (ecp did not count them all), and scarring that remained from a previous event.The pt was prescribed doxycycline bid by mouth and maxitrol eye drops tid.The pt was not provided a time frame to return for follow-up.The ecp stated again that the event is not due to the cl but due to the ¿pt's own staphylococcus bacteria from the pt¿s eyelids.¿ the ecp reported the pt did not have ¿bacterial keratitis.¿ on (b)(6) 2023, the pt¿s treating ecp provided additional information.The pt was seen on 30jan2023 for follow-up and was reported to have some improvement.The pt was continued on doxycycline by mouth, changed from bid to daily and instructed to continue maxitrol eye drops through the next day, then discontinue.The pt was scheduled for another follow-up on (b)(6) 2023 but cancelled the appointment.The pt has not returned to the office.No additional information has been received.A lot history review was performed and revealed the following: the batch records did not show any abnormalities in monomer and solution testing.All parameters tested were within specification.All sterilization requirements were successfully completed.Lot number l005nvr was produced under normal conditions.The suspect os cl was requested but has not been returned.No additional evaluation can be performed.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

Suspect product requested not received.

• Brand Name: ACUVUE® OASYS® FOR ASTIGMATISM
• Type of Device: LENSES, SOFT CONTACT, EXTENDED 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 ; 9047429918
• MDR Report Key: 16396828
• MDR Text Key: 309899346
• Report Number: 1057985-2023-00011
• 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,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: CYP
• Device Lot Number: L005NVR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2022
• 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: OPTI-FREE REPLENISH
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 40 YR
• Patient Sex: Female