ACUVUE? OASYS? PH

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2020-01-03 for ACUVUE? OASYS? PH manufactured by Johnson & Johnson Vision Care, Inc. ? Us.

Event Text Entries

[187459089] (b)(4). Initial reporter's phone number: (b)(6).
Patient Sequence No: 1, Text Type: N, H10

[187459090] On 16dec2019, a patient (pt) in (b)(6) reported a diagnosis of corneal ulcer in the left eye (os) while wearing an acuvue? Oasys? Brand contact lens (cl). The pt experienced symptoms of "conjunctivitis" in the os after 2 days of wearing the suspect cl. The pt experienced a? Scratchy feeling? And photophobia upon removal of the cl from the os. The pt visited an eye care provider (ecp) on (b)(6) 2019 and was diagnosed with a corneal ulcer. The pt was prescribed vymar antibiotic eye drop, 1 drop every 3 hours for 7 days; hyabak lubricating eye drop, 1 drop every 3 hours for 7 days; cold compress with saline, 3 times a day for 7 days. The pt reported daily wear and monthly replacement schedule. The pt used renu solution to clean cls. The date of event was (b)(6) 2019. No further information was provided. On 20dec2019, additional information was provided by the pt: the pt returned to the ecp for follow-up on (b)(6) 2019 and (b)(6) 2019 to be evaluated for proper treatment. The pt was advised on day 3 that the ulcer was healed. The pt was instructed to continue the use of the previously prescribed medication and to return to the ecp for follow-up after the treatment was complete. The pt is currently experiencing slight photophobia. The pt does not have a follow-up visit scheduled at this time. No further information was provided. On 24dec2019 the pt reported the os is ok now and has not returned to the ecp. Attempts were made to confirm the diagnosis with the treating ophthalmologist, but no further information was received. This event is being reported as a worst-case event as the diagnosis and treatment were unable to be verified. The suspect os contact lens was requested to be returned for evaluation but has not yet 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 b00r3w0 was produced under normal conditions. If any further relevant information is received, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1057985-2020-00001
• MDR Report Key: 9547000
• Report Source: CONSUMER,FOREIGN
• Date Received: 2020-01-03
• Date of Report: 2020-03-16
• Date of Event: 2019-12-06
• Date Mfgr Received: 2020-03-09
• Date Added to Maude: 2020-01-03
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: ROSE HARRELL
• Manufacturer Street: 7500 CENTURION PARKWAY
• Manufacturer City: JACKSONVILLE FL 32256
• Manufacturer Country: US
• Manufacturer Postal: 32256
• Manufacturer Phone: 9044433364
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: ACUVUE? OASYS?
• Generic Name: LENSES, SOFT CONTACT, EXTENDED WEAR
• Product Code: LPM
• Date Received: 2020-01-03
• Returned To Mfg: 2020-03-04
• Model Number: NA
• Catalog Number: PH
• Lot Number: B00R3W0
• Operator: LAY USER/PATIENT
• Device Availability: R
• Device Age: DA
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: JOHNSON & JOHNSON VISION CARE, INC. ? US
• Manufacturer Address: 7500 CENTURION PARKWAY JACKSONVILLE FL US

Device Sequence Number: 101

• Product Code: ---
• Date Received: 2020-01-03
• Device Sequence No: 101
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Required No Informationntervention	2020-01-03