ACUVUE OASYS?1 DAY WITH HYDRALUXE? TECHNOLOGY TSP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2020-02-27 for ACUVUE OASYS?1 DAY WITH HYDRALUXE? TECHNOLOGY TSP manufactured by Johnson & Johnson Vision Care, Inc. ? Us.

Event Text Entries

[187457328] (b)(4).
Patient Sequence No: 1, Text Type: N, H10

[187457329] On 05feb2020, a patient (pt) reported a diagnosis of corneal ulcer and? Nodules inflammation? In the right eye (od) in (b)(6) 2019 while using an acuvue oasys? 1 day with hydraluxe? Technology brand contact. The pt visited and eye care provider (ecp) initially (unspecified date) and was referred to a specialist. The pt visited an ophthalmologist (unspecified date) and was diagnosed with a corneal ulcer. The pt was prescribed a graft, patch for the eye, tobramycin and dexamethasone eye drops, 1 drop qid for a week. The pt visited the ophthalmologist for a follow-up (unspecified date) and the medication was continued 1 drop bid for 3 more days. The pt reported the corneal ulcer is currently resolved in the od, but the? Nodules? Are still there. The pt will need to visit another specialist. The pt reported a daily wear schedule and does not use any contact lens solution. On 10feb2020, the initial ecp was contacted and additional information was provided: the pt was diagnosed with salzmann's nodular degeneration (snd) and advised that the condition is not contact lens related. The ecp noted that the pt had the condition prior to being seen for contact lenses. The ecp reported that no treatment was provided, and the pt was referred to a specialist. Multiple attempts were made to contact the pt? S treating ophthalmologist for additional medical information. No additional information has been received. The suspect od product was discarded. 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 j001trq 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: 1057985-2020-00019
• MDR Report Key: 9765741
• Report Source: CONSUMER,HEALTH PROFESSIONAL
• Date Received: 2020-02-27
• Date of Report: 2020-02-27
• Date Mfgr Received: 2020-02-05
• Date Added to Maude: 2020-02-27
• 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?1 DAY WITH HYDRALUXE? TECHNOLOGY
• Generic Name: LENSES, SOFT CONTACT
• Product Code: LPL
• Date Received: 2020-02-27
• Model Number: NA
• Catalog Number: TSP
• Lot Number: J001TRQ
• Operator: LAY USER/PATIENT
• Device Availability: N
• 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: 2020-02-27
• Device Sequence No: 101
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Required No Informationntervention	2020-02-27