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); Foreign Body Sensation in Eye (1869); Red Eye(s) (2038)

Event Date 07/01/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, an on-line distributor sent an email advising a patient (pt) purchased acuvue® oasys for astigmatism brand contact lenses (cls).The cls ¿gave customer an eye infection.Dr gave eye drops.¿ no additional medical information was provided.On (b)(6) 2022, the pt provided additional information.The pt reported os burning upon insertion of a fresh lens and the os became ¿reddened.¿ the pt removed the suspect lens, cleaned the cl, and waited a day to reinsert.Upon reinsertion of the cl, the pt experienced burning sensation and irritation.The pt discarded the suspect cl and inserted a fresh cl and continued to experienced symptoms.The pt removed and discarded the 2nd cl and inserted a 3rd cl from the same box.The pt was able to wear the 3rd cl without issues for 3 days, then the os became red.The pt visited an eye care professional (ecp) and reported a diagnosis of os corneal ulcer and scar.The pt was treated with an unknown eye drop q2h x 4 days then q4 hours for another ¿few days.¿ the pt reported the event happened in july 2022 but is unsure of the exact date.The pt replaces cls monthly, does not sleep in cls, and uses opti-free solution to clean and store cls.The pt reported the os has healed at present and the pt has returned to cl wear.On (b)(6) 2022, the treating ecp provided additional information.A representative at the ecp¿s office advised the pt was initially seen on (b)(6) 2022.The pt was diagnosed with os peripheral ulcer ¿at 8:00 on clock face.¿ the pt was prescribed vigamox 1 drop every hour for 1 day, every 2 hours for 5 days, then every 4 hours for 3 days.The pt returned 10 days after the initial visit and was returned to vigamox every 2 hours for 5 days.The pt was asked to return for a 5 day follow up but did not return.The treating ecp ¿did not know if there was any scarring¿ as the ulcer had not healed the last time the pt was seen.On 30aug2022, the pt provided additional information.The pt stated that after receiving the corneal ulcer diagnosis from the ecp, a 2nd opinion was requested from a different ecp.The pt reported the 2nd opinion confirmed the ulcer and scarring.On (b)(6) 2022, a call was placed to the ecp that provided the 2nd opinion.A representative at the ecp¿s office reported the pt was seen on (b)(6) 2022 for ¿os ¿redness¿ after dust fell into the pt¿s eyes during speaker install.¿ the representative did not see a diagnosis or "scarring" in the pt¿s chart and no medications were prescribed.The pt has a ¿post-op¿ appointment on (b)(6) 2022 for follow-up.On (b)(6) 2022, the pt provided additional information.The pt confirmed there was no surgery requiring a ¿post-op¿ appointment.The surgery in question was lasik surgery, but the pt did not undergo the procedure.The pt did not have a cl exam at the time of the ecp visit; only an eyeglass exam as the ¿ecp wanted the ¿scarring¿ to heal.¿ the pt has returned to cl wear with the current cl prescription.Multiple attempts for confirmation of ¿scarring¿ were made to both ecp offices.No additional information has been received.This report is being submitted as a worst-case event as we were unable to verify ¿os corneal scarring¿ with a healthcare provider.The lot number is unknown.The os suspect product was discarded.No additional evaluation can be conducted.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

Suspect os contact lens discarded.

• 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: 15426607
• MDR Text Key: 299939879
• Report Number: 1057985-2022-00070
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• 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: 08/23/2022
• 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
• Treatment: OPTI-FREE
• Patient Outcome(s): Disability; Required Intervention; Other
• Patient Age: 41 YR
• Patient Sex: Male