MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. - US 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 Scar (1793); 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 11/23/2022

Event Type  Injury  

Manufacturer Narrative

Suspect od cl was discarded.

Event Description

On (b)(6) 2023, a patient (pt) in the united states reported ¿not seeing well,¿ ¿eyes swollen shut,¿ a ¿gritty feeling,¿ photophobia, and tearing while wearing acuvue® oasys® for astigmatism brand contact lenses (cls) in both eyes (ou) during (b)(6) 2022.The pt visited an eye care professional (ecp) and was diagnosed with a ¿bacterial infection after wearing cls too long.¿ the pt was prescribed neopolydex 1 drop three times a day (tid) ou for 7 days.The pt returned to the ecp 3 days later and the prescription was changed to moxifloxican ou four times a day (qid) for 7 days.The pt stated the ecp advised that the pt¿s eyes are very dry.The pt was told the ¿infection¿ was clearing but to follow up for any worsening irritation and not to wear cls for 2 weeks.Pt stated ou cleared and the pt resumed cl wear in (b)(6) 2023.On 26jan2023, 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) 2022, diagnosed with "staph marginal keratitis" ou, 3 right eye (od) ulcers around the limbus and 1 left eye (os) ulcer around the limbus.The pt was prescribed vigamox eye drops ou qid for 3 days then follow up.On (b)(6) 2022, the pt¿s prescription was changed to maxitrol eye drops tid for 7 days.The pt was seen again on (b)(6) 2022.The infection resolved with 3 od limbal scars and 1 os limbal scar, nothing central and no change in visual acuity.The pt was told to wait until the next monday to resume cl wear, start with a new pair and wear eyeglasses more frequently.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¿.No additional information has been received.This report is for the pt's od event.The report for the pt's os event will be provided in a separate report.The lot number for the od cl is unknown.The suspect od cl was discarded.No additional evaluation can be performed.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: ACUVUE® OASYS® FOR ASTIGMATISM
• 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: helene aguilar ; 7500 centurion parkway; jacksonville, FL 32256 ; 9047429918
• MDR Report Key: 16396888
• MDR Text Key: 309753906
• Report Number: 1057985-2023-00013
• 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
• 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
• 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; Disability
• Patient Age: 39 YR
• Patient Sex: Female