MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND 1-DAY ACUVUE MOIST; LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number 1DM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Red Eye(s) (2038); Swelling (2091); Discomfort (2330)

Event Date 09/21/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

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.

• Brand Name: 1-DAY ACUVUE MOIST
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND; one technological park plassey; limerick ; EI
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 9765368
• MDR Text Key: 181479950
• Report Number: 9617710-2020-00008
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: N18033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/01/2024
• Device Catalogue Number: 1DM
• Device Lot Number: 6223020108
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/02/2019
• Initial Date FDA Received: 02/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 27