1-DAY ACUVUE? MOIST? 1DM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,other report with the FDA on 2020-02-27 for 1-DAY ACUVUE? MOIST? 1DM manufactured by Johnson & Johnson Vision Care, Inc. ? Ireland.

Event Text Entries

[181479950] (b)(4). (b)(6).
Patient Sequence No: 1, Text Type: N, H10

[181479951] On 02oct2019 an email was received from (b)(6). A patient (pt) in the (b)(6) self-reported to (b)(6) "i went to my opticians for a contact lense eye test, i had the following lenses - batch code/lot 622302 0108 00000303 exp 01/06/2024 (batch code 8. 5) and batch 8. 5 lot 13607001 08x exp 06/2020?. The patient experienced a gritty sore feeling od wearing lot 622302 0108 00000303; the pt removed the lenses. Several days later the pt complained of discomfort after inserting another lens in the od; the os was unaffected. The pt reported waking up on (b)(6) 2019 with a stabbing pain, light sensitivity, red eye, swelling and difficulty opening the od requiring treatment with high strength antibiotics. On 19feb2020, following information was received via email from the pt: the suspect lenses were not available for return for evaluation. The pt confirmed receiving emergency care on (b)(6) 2019 and required 2 subsequent follow-up appointments. The od was the only affected eye. No diagnosis was provided by the emergency care facility. Levofloxacin gtts were prescribed hourly for 1 week, then every 2 hours for two weeks. Drops were also prescribed to? Dilate my pupil? Three times per day. After discontinuing contact lens wear for one month the pt returned to 1-day moist brand contact lenses without further event. No additional medical information is available at this time. A lot history review was performed for lot 6223020108: 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 6223020108 was produced under normal conditions. A lot history review was performed for lot 1360700108: 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 1360700108 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: 9617710-2020-00008
• MDR Report Key: 9765368
• Report Source: CONSUMER,FOREIGN,OTHER
• Date Received: 2020-02-27
• Date of Report: 2020-02-27
• Date of Event: 2019-09-21
• Date Mfgr Received: 2019-10-02
• 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: 1-DAY ACUVUE? MOIST?
• Generic Name: LENSES, SOFT CONTACT, DAILY WEAR
• Product Code: LPL
• Date Received: 2020-02-27
• Model Number: NA
• Catalog Number: 1DM
• Lot Number: 6223020108
• 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: 2020-02-27
• 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