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); Keratitis (1944); Pain (1994); Red Eye(s) (2038); Swelling (2091); Burning Sensation (2146); Excessive Tear Production (2235)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A social media post was received from a patient (pt) in (b)(6) on 24oct2019.On 29oct2019, an email was received with a copy of the medical report (dated 17oct2019) from the treating eye care provider (ecp) stating the pt was ¿recently admitted for left eye infective keratitis, secondary to contact lens use." the pt reported a diagnosis of a ¿cornea infection¿ while wearing acuvue® oasys® brand contact lenses (cl).The pt experienced discomfort on (b)(6) 2019 and removed the suspect cls 3 hours later.On (b)(6) 2019, both eyes were red with ¿burning pain.¿ on (b)(6) 2019, the pt experienced swelling and tearing.On (b)(6) 2019, the pt visited and eye care provider (ecp) and was diagnosed with a ¿cornea infection due to the contact lenses and will be warded soon.¿ the pt also experienced dry eye with the cls.On 04nov2019, the treating ecp was contacted, and additional information was received.The pt visited the ecp on (b)(6) 2019 and was diagnosed with left eye (os) ¿infective keratitis.¿ the pt was prescribed vigamox, every hour os.The pt was advised to discontinue cl wear.At the follow-up visit on (b)(6) 2019, the os condition was improving, but the ¿infective keratitis¿ was ¿still active.¿ the frequency of vigamox was reduced to every 2 hours os.No additional follow-up visits have been scheduled.No further information was provided.On 06nov2019, the pt was contacted, and additional information was provided.The pt confirmed wearing an acuvue® oasys® brand contact lens in the os at the time of the event.The pt reported using 4 lenses from the suspect box.The pt experienced discomfort ¿since the first pair.¿ the pt couldn¿t confirm any issues with the suspect lenses but was unable to wear the lenses for more than a week.The pt reported the os is improving and an ecp follow-up visit is scheduled for (b)(6) 2019.The ecp advised the pt to discontinue cls permanently.No further information was provided.On 13nov2019, the pt sent an email providing additional information.Pt reported the ecp follow up visit was rescheduled for (b)(6) 2019.On 15nov2019, an email was received from the pt reporting that the suspect os contact lenses were discarded.On 19nov2019, medical receipts were received from the pt with additional information.The pt was hospitalized from (b)(6) 2019 to (b)(6) 2019.The pt was seen by the ecp on (b)(6) 2019 for follow-up visit, also noted ¿cornea, dendritic ulcer, epithelial debridement.¿ the pt was seen by the ecp for additional visits on (b)(6) 2019.Pharmacy receipt (dated (b)(6) 2019): vigamox, ciloxan, evolve ha 0.2% 10 ml.Pharmacy receipt (dated (b)(6) 2019): vigamox.The pt reported weekly follow-up visits with the ecp are still ongoing and the pts next ecp visit has been rescheduled to (b)(6) 2019.No further information was provided.On 21nov2019 an email was received from the pt with a follow-up medical report dated, 21nov2019: the ecp reported that the pt was "recently admitted for left eye keratitis, secondary to contact lens use.I first saw the pt on (b)(6) 2019.The pt was wearing contact lenses, a few days before, and developed bilateral red eyes and pain.The pt was found to have bilateral infective keratitis, with the left eye being more severe than the right.The pt was admitted and received topical intensive antibiotics.The pt has since showed good healing, and his overall symptoms of pain and discomfort have reduced.I will continue to monitor his progress." the pt reported an ecp follow-up visit scheduled for (b)(6) 2019.The event date is 2019.This report is for the os event.A separate report will be filed for the right eye (od) event.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 b00s94d was produced under normal conditions.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
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 9357692
• MDR Text Key: 185036556
• Report Number: 1057985-2019-00131
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): Y
• Reporter Country Code: SN
• 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: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• 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: PH
• Device Lot Number: B00S94D
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2019
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention