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 Inflammation (1932); Irritation (1941); Keratitis (1944); Red Eye(s) (2038); Swelling (2091); Discharge (2225)

Event Date 08/06/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter's phone number: (b)(6).

Event Description

On 10aug2020 a patient (pt) in (b)(6) called to report ¿edema and cornea inflammation¿ on the eyes after 1 day of wearing the acuvue® oasys® for astigmatism brand contact lenses on (b)(6) 2020.The pt reported redness, edema, discharge on both eyes, and a ¿corneal lesion¿ was found after a few hours of contact lens (cls) wear.The pt advised the os was worse.The pt didn¿t notice anything unusual about the suspect lenses when removed.The pt went to an eye care provider (ecp) on (b)(6) 2020 and advised of a ¿lesion and edema on both corneas.¿ the pt was prescribed vigamox 1 drop every 4 hours for 3 days, then decrease the dosage to every 6 hours, and finally every 8 hours.The pt was also prescribed optive lubrication eye drops.The ecp recommended the pt avoid cls wear until (b)(6) 2020.The pt reports daily cls wear with a 1-2 month replacement schedule.On 11aug2020 a call was placed to the pts treating ecp and additional information was requested, but no additional medical information was provided.On 11aug2020 a call was placed to the pt and additional information was provided.The ecp advised the pt has ¿lesions ou¿ with the os being worse than the od.The pt reported no return visit was scheduled, but the pt was told to return if the symptoms didn¿t improve.The medical report was requested.On 11aug2020 an email was received from the pt with the medical report.The pt presented to emergency service.Biomicroscopy: od: keratitis + and hyperemia +; oe: keratitis +++ and hyperemia +++.Diagnosis: keratitis ou; icd code h18.0: other disorders of cornea.Medications: vigamox every 4 hours ou; optive every 8 hours ou; suspend cls use.No additional medical information has been received.A lot history review was performed and revealed the following: the batch record did not show any abnormalities in monomer and solution testing.All parameters tested were within specification.All sterilization requirements were successfully completed.Lot b00s9jt was produced under normal conditions.The suspect os contact lens was discarded.No additional investigation can be conducted.This report is for the pts os event.A separate report will be filed for the pt's od event.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, INC. ¿ US; 7500 centurion parkway; jacksonville FL
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 10476320
• MDR Text Key: 205123281
• Report Number: 1057985-2020-00046
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): Y
• Reporter Country Code: BR
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/01/2024
• Device Catalogue Number: CYP
• Device Lot Number: B00S9JT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 24 YR