MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND ACUVUE 2; LENSES, SOFT CONTACT, EXTENDED WEAR

Catalog Number AV2

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

Patient Problems Corneal Ulcer (1796); Unspecified Infection (1930); Irritation (1941); Red Eye(s) (2038); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2020, an email was received from a patient (pt) in (b)(6) reporting a diagnosis of an ¿eye infection with corneal ulcer¿ while wearing an acuvue® 2® brand contact lens.No further information was provided.On (b)(6) 2020, additional information was received from the pt: the pt reported experiencing redness, irritation, and swelling on the right eye (od).The pt visited a doctor and was diagnosed with ¿eye infection with corneal ulcer¿ od.Event date is unknown.No further information was provided.Multiple attempts have been made to obtain the medical record from the pt.No additional information has been received.This event is being reported as a worst-case event as the diagnosis and treatment were unable to be verified.The suspect od contact lens was requested for return and 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 l003w93 was produced under normal conditions.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: ACUVUE 2
• Type of Device: LENSES, SOFT CONTACT, EXTENDED 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: 10408756
• MDR Text Key: 203630341
• Report Number: 9617710-2020-00017
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): Y
• Reporter Country Code: IN
• PMA/PMN Number: N18033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/01/2024
• Device Catalogue Number: AV2
• Device Lot Number: L003W93
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention