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

Catalog Number PH

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

Patient Problems Corneal Scar (1793); Corneal Ulcer (1796); Foreign Body Sensation in Eye (1869); Red Eye(s) (2038); Blurred Vision (2137); Visual Disturbances (2140); Excessive Tear Production (2235); Eye Pain (4467)

Event Date 06/01/2022

Event Type  Injury  

Event Description

On (b)(6) 2022 a representative from an eye care professional¿s (ecp) office called to report os redness every time a patient (pt) would wear the acuvue® oasys® brand contact lenses (cl).The pt advised that the os felt ¿strange¿ but when the pt removed the suspect os cl, the pt didn¿t notice anything abnormal with the cl.The representative reported the pt¿s os was red and irritated upon removal of the cl.The pt may have relocated and visited another ecp who diagnosed the pt with the os corneal ulcer.The os corneal ulcer event date was unknown, and the diagnosis was not verified with the other ecp.The representative will ask the pt to call directly to provide additional medical and product information.On (b)(6) 2022 the pt provided additional information.The pt reported the os corneal ulcer occurred at the end of jun2022( exact date unknown).The pt reported being ¿bedridden¿ on (b)(6) 2022 and ¿could not see out of os.¿ the pt reported sleeping in lenses the night prior to the symptoms beginning.The following am, the pt woke with ¿minor redness¿ and wore glasses that day.The pt reported when going out in the sunlight during lunch, ¿the os got much worse.¿ the following am the pt could barely open the os, had extreme light sensitivity and pain.The pt went to an urgent care who advised the pt that they ¿removed some type of white film with tools and put a blue dye in the eye.¿ the pt was referred to an ecp who prescribed ketoralac every hour for the first day, then it decreased to every 2 hours, then ¿continuing to taper.¿ the pt was also instructed to use artificial tears twice daily and to take vitamin c.The pt was cleared to return to cl wear, but ¿didn¿t wear lenses for a while.¿ the pt still has minor os redness, but no pain.The pt reported prior to the os corneal ulcer, the pt was frustrated with the oasys lenses ¿drying out after just 2-3 uses and the pt had to discard the lenses.¿ the pt reported the eyes were fine after removing the lenses, but the pt could ¿feel the lenses were harder.¿ on (b)(6) 2022, a call was placed to the pt¿s treating ecp.A representative advised the pt presented to the ecp on (b)(6) 2022 with complaints of redness, tearing, and pain.The pt was diagnosed with an os corneal ulcer, cl over-wear ou.The pt was prescribed erythromycin ointment 0.25 cm nightly, duration was not noted.The pt was also prescribed cipro/besivance every 30 minutes on 1st day, then every hour for 2 days, then every 2 hours on day 4.On (b)(6) 2022, the pt returned for follow-up (fu) visit: os corneal ulcer is unresolved but improving.Erythromycin was discontinued; taper besivance to every 4 hours.On (b)(6) 2022, the pt returned for fu visit: the os was better.The pt was advised to taper cipro to twice daily for 1 week, then daily for 1 week.On (b)(6) 2022, fu visit ¿ os corneal ulcer was resolved.Multiple stromal scars os; conjunctiva/sclera os 2-3 + injection.Location of ulcer was not noted in the record.No additional information was noted.On (b)(6) 2022, the pt refused to provide any additional medical information.No additional medical information has been received.No additional medical information is expected.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 l005715 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

Os suspect product discarded.

• Brand Name: ACUVUE® OASYS®
• 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: 15372912
• MDR Text Key: 299447812
• Report Number: 1057985-2022-00069
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: PH
• Device Lot Number: L005715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/15/2022
• Initial Date FDA Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2021
• 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; Disability; Required Intervention
• Patient Age: 33 YR
• Patient Sex: Female