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 Bacterial Infection (1735); Corneal Scar (1793); Corneal Ulcer (1796); Foreign Body Sensation in Eye (1869); Corneal Clouding/Hazing (1878); Headache (1880); Red Eye(s) (2038); Visual Impairment (2138); Visual Disturbances (2140); Excessive Tear Production (2235); Eye Pain (4467)

Event Date 05/18/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, a patient (pt) in mexico sent an email to report a ¿corneal ulcer, which resulted in a very large infection and almost the loss of my eye¿ after wearing an acuvue® oasys® for astigmatism brand contact lens (cl) on the left eye (os).The pt reported the box of six lenses were purchased in (b)(6) 2021 at an optician¿s office.On (b)(6) 2022, the pt reported using one of the new cls and within hours experienced discomfort and went to a doctor.The pt presented to an ophthalmologist who diagnosed the corneal ulcer on (b)(6) 2022.The pt is waiting for a corneal transplant due to the corneal damage and reported ¿can¿t see with this eye.¿ the pt reported that after examining the box of lenses, the pt noticed the cls expired in 2020.On (b)(6) 2022, after receiving the email, the pt provided additional information.The pt didn¿t open the lenses purchased in dec 2021 until (b)(6) 2022.The pt reported ¿the box looked discolored¿ when purchased, but purchased the box anyway, ¿since the optical is so far away.¿ the pt reported os foreign body sensation a couple of hours after inserting the lens from the sealed blister package.The pt removed the suspect cl but continued to experience os discomfort.The pt advised the discomfort worsened throughout the evening and experienced headache, pain, red eye and tearing.The pt was prescribed a prescription for unknown eye drops by a primary care physician (date not provided).On (b)(6) 2022, the pt was referred to an ophthalmologist as the ¿eye looked worse.¿ the pt was then given three eye drops (names were unknown) to use hourly for 15 days, keflex tablets every six hours for three weeks and was advised of the corneal ulcer diagnosis with a ¿bad infection.¿ the pt reported the eye drops were changed after fifteen days to another unknown antibiotic, hourly for fifteen days.The antibiotic was changed again ¿after completion¿ and the pt was started on vigamox hourly for 15 days with zymax hourly for fifteen days.The vigamox was reduced to every three hours, then every six hours for ten days.The pt was also prescribed flutinol drops and lubricating eye drops.The ophthalmologist advised that a corneal transplant may be needed in the os.The pt can see a ¿white stain in the middle of the eye that is causing the pt¿s os vision to be impaired.¿ the pt has a follow-up appointment in (b)(6) and the doctor will advise at that visit if the corneal transplant is needed.The pt reported almost daily visits with the ophthalmologist for one month.The pt did not recall the name of the solution used and doesn¿t sleep in cls.The pt was advised the corneal ulcer was caused by using an expired lens.On (b)(6) 2022, the pt¿s medical records were received.Eye care professional (ecp) date of visit: (b)(6) 2022.The pt presented with foreign body sensation, tearing, redness and irritation of the os.The pt is a cl wearer.Exam os: ulcer in the meridian at 12 o¿clock secondary to cl use.The ulcer is approximately 1.2 mm deep, whitish with abundant necrotic tissue, rheumy, red eye, and intolerant to light.Retina disc and macula aspect is normal.Diagnosis: corneal ulcer os.Treatment prescribed: vancomycin 0.4% hourly; zymar hourly; keflex 500mg by mouth every 6 hours and ceftriaxone 1gm every 24 hours for 5 days.The pt has history of lasik ii.A picture of a prescription dated, (b)(6) 2022 for vancomycin 0.4% hourly; zymar hourly; keflex 500mg by mouth every 6 hours and ceftriaxone 1gm intramuscularly every 24 hours for 5 days.A picture of a prescription dated (b)(6) 2022 for zymar hourly for 3 days.A picture of a prescription dated (b)(6) 2022 for vigamox 1 drop hourly; vancomycin 1 drop every three hours.; py (oftenocefenilefrina) tabs every 6 hours, phenylephrine pupil dilator.A picture of prescription dated (b)(6) 2022 for vigamox 1 drop hourly; vancomycin 0.4% 1 drop every 3 hours; keflex 500 mg by mouth every 6 hours; tp (oftenocefenilefrina) 1 drop every 6 hours ¿phenylephrine pupil dilator.A picture of prescription dated (b)(6) 2022 for zymar 1 drop hourly; vigomoxi 1drop hourly; flumetul every 6 hours and keflex 500mg 1 tab by mouth every 6 hours.A picture of prescription dated (b)(6) 2022 for hiperton 0.5% 1 drop every 6 hours (antibacterial); prednetin 1 drop every 6 hours; vigamoxi 1 drop every 6 hours.A picture of prescription dated (b)(6) 2022 for homylub 1drop every 6 hours (starting on (b)(6) 2022); vigamoxi 1 drop every 6 hours x 1 week; prednetin 1 drop every 6 hours x 1 week; hiperton 1 drop every 6 hours x 1 week on (b)(6) 2022 the pt reported cls were only used for ¿special occasions¿ and was advised the lenses could be used up to 3 months.The pt has a follow-up appointment on (b)(6) 2022.The pt agreed to provide additional information with a follow-up phone call.On (b)(6) 2022 the pt provided additional information.On the (b)(6) 2022 follow-up appointment the ecp advised the pt ¿everything was healing well¿ and instructed the pt to continue using the lubricating drops for another 7 days.The pt has another follow-up appointment on (b)(6) 2022 and agreed to provide additional information with a phone call.On (b)(6) 2022, the pt provided additional medical information.An ecp note dated (b)(6) 2022 reports, ¿today pt presents with a very good evolution, a cloud is observed in the corneal center that affects the pupillary axis and deteriorates vision.This little cloud has been especially migratory from the periphery to the center, following the virtual schism left by the previous lasik surgery.The prognosis is good in the medium term in that the corneal is not perforated but requires anterior lamellar transplant or corneal perforating transplant evaluation.¿ treatment: mumylab (lubricating drops) 1 drop q6h.Follow-up in 1 month.No additional medical 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 l002p9w was produced under normal conditions.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.

Manufacturer Narrative

Suspect product was discarded.

Manufacturer Narrative

On 29aug2022, the patient (pt) provided additional information.The pt reported the os is getting better, "scarring" is getting better.The pt will not follow-up with surgeon at this time.The pt has a routine eye exam scheduled in 2 weeks.No additional medical information has been received.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 - IRELAND; 1 technological park plassey; limerick LK130 01; EI LK13001
• Manufacturer Contact: helene aguilar ; 7500 centurion parkway; jacksonville, FL 32256 ; 9047429918
• MDR Report Key: 15059434
• MDR Text Key: 296211171
• Report Number: 1057985-2022-00048
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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,Followup
• Report Date: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/01/2020
• Device Catalogue Number: CYP
• Device Lot Number: L002P9W
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2015
• 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: 35 YR
• Patient Sex: Female