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 Abrasion (1789); Corneal Ulcer (1796); Deposits (1809); Foreign Body Sensation in Eye (1869); Local Reaction (2035); Red Eye(s) (2038); Blurred Vision (2137); Visual Disturbances (2140); Excessive Tear Production (2235); Eye Burn (2523); Eye Pain (4467); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/01/2024

Event Type  Injury  

Event Description

On 04mar2024, a family member called to report a patient (pt) experienced burning sensation, pain, and was "not able to see" from the eye (affected eye not provided) "around 12-13feb2024." the pt visited an emergency room (er) and multiple eye care professionals (ecps) as the pt travels for work.The family member reported the pt visited a hospital, was given a pain killer and was sent home.The pt was diagnosed with a corneal ulcer, continued traveling, and visited another er for pain and burning sensation.On 04mar2024, the pt provided additional information.The pt confirmed the information previously provided by the family member.The pt has worn acuvue brand contact lenses (cls) for many years.On the first day of wearing an acuvue® oasys® for astigmatism brand cl, the pt's vision became blurry in the left eye (os) and the pt removed the cl.Upon removal, the pt experienced pain, tearing, and blurry vision, and "felt like there was something in the eye," and "looked like there was an "oily," cloudy film on the eye.The pt did not use any lotions or come in contact with any substances which would potentially make the eye feel "oily." the cl was intact upon removal.The pt visited an er and was diagnosed with an os corneal ulcer.The "eye was rinsed with solution." the pt was not prescribed any medications, and was advised to visit an ecp the following day.The pt visited an ecp on 16feb2024 and the os corneal ulcer diagnosis was confirmed.The ecp removed "something very small" on the eye.The pt was prescribed lotemax ointment to use before sleep for 1 week, ciprofloxacin 1 drop every 6 hours while awake (5 times daily) for one week or until cleared.The pt reported using the eye drops until the "eye was ok," and stated the eye was better the following day.The pt confirmed the medication was not used for the prescribed duration.The pt was seen by the ecp for follow-up on 19feb2024 and "was told the os was ok," was advised to not wear cls for 5 days and then ok to return to cl wear.On (b)(6) 2024 the pt inserted a new cl and after a few hours of wear, experienced the same symptoms.The pt visited a different er and was told "it looked like there was a 'light scratch' on the os, but looked like it could be an allergic reaction." a numbing eye drop was used and the eye was rinsed.The pt was prescribed lotemax ointment to prevent a bacterial infection (duration not provided).The pt stated the os felt better the following day.On (b)(6) 2024, the pt inserted a new cl and had to remove it "after a few hours of wear" due to irritation, burning, tearing eyes, and a ¿film¿ on the eye.The pt did not visit an ecp and self-treated with medication previously prescribed and used cold compresses.The pt has not returned to cl wear.The pt will return to the ecp for additional evaluation (date not provided).On 04mar2024, a call was placed to the pt's first treating ecp for additional medical information.A representative at the ecp's office stated the pt was seen on 15feb2024, was diagnosed with os central corneal ulcer, os cornea foreign body removal, and chemical kerathopathy.The pt's chart indicates the pt visited er due to ¿clorox mist sprayed in his os¿ where the eye was irrigated with saline solution.The pt presented to the office with a lot of eye pain.An allograft was placed in pt¿s corneal ulcer, and the os was hydrated with besivance and gentamicin after removal of a foreign body.The pt was prescribed lotemax at night, no duration, and ciprofloxacin 4 times a day (qid), no duration noted.The size of the non-infectious ulcer was not noted but indicated as "possibly due to cl wear." the pt returned to office on 19feb2024 for follow-up and reported "feeling better and vision improved." exam noted little staining on the cornea and the pt was advised to discontinue overnight cl wear for 1 week as the eye is still healing.Pt to continue lotemax at night, and ciprofloxacin qid, no duration noted.The pt was to return for a new cl fitting but has not returned.Additional attempts were made to the pt for complaint information on 11mar2024 and 18mar2024 with no success.On 18mar2024, a call was placed to the pt's first treating ecp for additional information.A representative at the ecp's office stated the besivance and gentamycin used after placing the allograft membrane was used to promote healing.The pt returned for follow-up on 19feb2024 and "it looked like the eye was healing." fine inferior punctate staining and tearing were observed.The pt returned on 04mar2024 complaining of a "defective" cl that was "ripped" in the middle causing redness, swelling and tearing (affected eye not provided).Fine inferior punctate staining was observed.The returned for follow-up again on 08mar2024 with persistent superficial punctate keratitis (spk) staining observed.The pt was prescribed a different cl brand and asked to return in 2 weeks.No additional information has been received.No additional medical information has been received.The date of the pt¿s event is being recorded as 01feb2024 as the exact event date is unknown.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 b015q8f was produced under normal conditions.One lens case containing two lenses was received for lot number b015q8f.Magnified visual inspection revealed one lens with a surface tear on one lens that was torn.If any further relevant information is received, a supplemental report will be filed, as appropriate.

• 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: 19004138
• MDR Text Key: 338911470
• Report Number: 1057985-2024-00011
• 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: Other,Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• 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: B015Q8F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2024
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2023
• 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