1-DAY ACUVUE? MOIST? FOR ASTIGMATISM 1MA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,health profe report with the FDA on 2020-01-13 for 1-DAY ACUVUE? MOIST? FOR ASTIGMATISM 1MA manufactured by Johnson & Johnson Vision Care, Inc. ? Ireland.

Event Text Entries

[184057362] (b)(4). (b)(6).
Patient Sequence No: 1, Text Type: N, H10

[184057363] On (b)(6) 2019 a call was received from a patient (pt) in (b)(6) who reported eye itching and discharge (affected eye not provided) while wearing the 1-day acuvue moist for astigmatism brand contact lenses. The pt went to an eye specialist who diagnosed conjunctivitis and keratitis and prescribed eye drops (details were unknown). The pt reported the eye improved. On 23dec2019 a call was placed to the ecp who provided additional information: the ecp reported the pt experienced discomfort while wearing the suspect lenses, however no additional medical information is known. On 23dec2019 a call was placed to the pt who provided additional information: the pt reported both eyes were affected. The pt reported the eye specialist prescribed: chloramphenicol ophthalmic solution, day and night; erythromycin eye ointment, day and night; tobrex sterile ophthalmic solution, every 3 hours; tears naturale lubricant eye drops, when eye feel dry; totifen ophthalmic solution (ketotifen), morning. The pt no longer has the medical report from the eye specialist. On 03jan2020 additional information was received from the pt: the pt confirmed the eyes have recovered, however there is a? White spot? On the right eye (od) which the doctor confirmed to be scar tissue. The pt is not experiencing any other issues. The pt is not able to provide a medical report. The pt is currently using contact lenses. No further information was provided. On 10jan2020 additional information was received from the pt: the pt stated the? White spot (scar tissue)? On the od has resolved and is no longer there. Both eyes are fully recovered. No further information was provided. No additional medical information has been received. The event date is unknown. This event is being reported as a worst-case event as we were unable to verify the pts diagnosis and treatment. This report is for the od event. A separate report will be filed for the left eye (os) 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 3048520104 was produced under normal conditions. The suspect od contact lens was discarded. No additional evaluation can be completed. 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: 9617710-2020-00001
• MDR Report Key: 9583201
• Report Source: CONSUMER,FOREIGN,HEALTH PROFE
• Date Received: 2020-01-13
• Date of Report: 2019-12-23
• Date Mfgr Received: 2019-12-23
• Device Manufacturer Date: 2018-11-01
• Date Added to Maude: 2020-01-13
• 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: 1-DAY ACUVUE? MOIST? FOR ASTIGMATISM
• Generic Name: LENSES, SOFT CONTACT, DAILY WEAR
• Product Code: LPL
• Date Received: 2020-01-13
• Model Number: NA
• Catalog Number: 1MA
• Lot Number: 3048520104
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: JOHNSON & JOHNSON VISION CARE, INC. ? IRELAND
• Manufacturer Address: ONE TECHNOLOGICAL PARK PLASSEY LIMERICK EI

Device Sequence Number: 101

• Product Code: ---
• Date Received: 2020-01-13
• Device Sequence No: 101
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Required No Informationntervention	2020-01-13