MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. - US ACUVUE® OASYS®; LENSES, SOFT CONTACT, EXTENDED WEAR

Catalog Number PH

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); Red Eye(s) (2038); Visual Disturbances (2140)

Event Date 10/01/2022

Event Type  Injury  

Manufacturer Narrative

Suspect product discarded.

Event Description

On(b)(6)2023 , a patient (pt) in brazil posted on a social media website that while wearing an unknown acuvue brand contact lens (cl) the pt was diagnosed with a corneal ulcer.The pt advised, ¿i don¿t know what happened if it had a bacteria i don¿t want to know either i don¿t want to know i got an ulcer in the eye was growing growing¿¿ the pt also reported, ¿i bought two boxes but just a little spot on the eye even though i went through it, right ophthalmologist, right because of one bad quality¿¿ the pt also provided a picture of a cell phone showing a picture of an eye.No additional medical information was provided.On (b)(6)2023 , the pt called to provide additional information.The pt reported left eye (os) irritation, redness, photophobia, burning sensation, and felt like ¿sand in eye¿ while wearing an acuvue® oasys® brand cl in oct2022.The pt went to an eye care professional (ecp) who diagnosed the pt with an ¿os bacterial corneal ulcer.¿ the pt was prescribed vigamox 1 drop every hour for 2 days, then 1 drop every 2 hours until return evaluation (evaluation date not provided).The pt returned to the ecp after 15 days and was then prescribed vigamox 1 drop every 6 hours for 7 days.The pt was prescribed regencel cream in am and pm for 10 days and lacrifilm lubricating drops every 3 hours for 20 days after use of the vigamox drops.The pt has a report that states, ¿os serious corneal ulcer 7mm, due to cl wear.¿ the pt reported ¿¿¿it was very close to the field of vision¿ and agreed to send copy of prescription and documentation via email.The pt advised there is a ¿small scar with visible white spot on os which will be permanent.¿ the pt has not been cleared to return to cl wear, but has a follow-up appointment with the ecp tomorrow, (b)(6)2023.On (b)(6)2023 additional information received from the pt by email.-auto refraction reading and auto keratometry results dated (b)(6)2022 -received image of eye on cell phone ¿ duplicate image, received with initial complaint on (b)(6)2023 -received 2nd image of eye -visit report from ecp dated(b)(6)2022: ¿in ophthalmologic er ¿ pt user of cl with serious corneal ulcer on os, refers to sleeping in cl with replacement every 15 days.Auto refraction os: -4.00/-0.50/30; avsc os: 20/70 ¿os eyelid unchanged, calm eye, transparent cornea with para-central ulcer at 7 o¿clock, circular, measuring 4mm in diameter with hardened and infiltrated center, fluoro neg, no flare, fr pupil.Today initiated vigamox every 1 hour.¿ -email prescription received from the pt with illegible date.Special control prescription - vigamox ophthalmologic solution, use 1 drop on os every 1 hour for 2 days, then instill 1 drop every 2 hours until return for new medical evaluation with ophthalmologist.On(b)(6)2023 , a call was placed to the pt requesting the pt to resend the prescription with illegible date.No additional information has been received.On (b)(6)2023 , additional medical information was received from the patient (pt).The pt returned to the eye care professional (ecp) on (b)(6)2023.The pt was advised by the ecp that the cornea is 88% healed.The pt was instructed to continue the use of medications for 15 days, vigamox 2 drops every 3 hours, regencel cream in the am and pm and lacrima plus every hour as needed to keep the eye hydrated.The ecp advised the pt will not be able to wear contact lenses (cls) for about 24 months.The ecp advised that ¿if this treatment does not improve the eye condition¿ the ecp will prescribe a ¿different antibiotic in attempt to minimize the size of the scar.¿ the ecp advised the pt that ¿this bacteria is very advanced.¿ the pt has a return ecp visit on (b)(6)2023.On(b)(6)2023 , a call was placed to the pt¿s treating ecp to verify diagnosis and treatment.A representative advised that only the pt may request the medical information.No additional medical information was provided.On (b)(6)2023 , a call was placed to the pt and a detailed voice mail message was left requesting the pt to obtain the medical records from the ecp visits.No additional medical information has been received.The lot number of the os suspect product is unknown.The os suspect 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®
• 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: 16396211
• MDR Text Key: 309792360
• Report Number: 1057985-2023-00012
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• 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: PH
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2023
• 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): Disability; Other; Required Intervention
• Patient Age: 32 YR