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

Catalog Number AV2

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

Patient Problems Bacterial Infection (1735); Conjunctivitis (1784)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2020, a patient (pt) reported a diagnosis of bacterial conjunctivitis while wearing acuvue® 2® brand contact lenses in both eyes.The pt reported the issue started a few months ago (unspecified date) and the pt visited a walk-in-clinic and was diagnosed with bacterial conjunctivitis.The pt was prescribed ofloxacin, one drop qid for 7 days.The event resolved and the pt resumed contact lens wear.The pt reports daily wear with a 2-week contact lens replacement schedule.The pt provided consent to contact the treating eye care provider (ecp) but refused to provide date of birth to obtain medical information.The date of event is unknown.Attempts were made to obtain additional information from the pt and medical information from the ecp, but no medical information will be provided without the pt¿s date of birth.No further information has been received and no further information is expected.The suspect contact lenses were discarded.No product or lot information was available.No analysis could be conducted.This report is for the right eye (od) event.A separate report will be filed for the left eye (os) event.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. ¿ US; 7500 centurion parkway; jacksonville FL
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 9759254
• MDR Text Key: 190334221
• Report Number: 1057985-2020-00018
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: N18033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: AV2
• Device Lot Number: UNK-AV2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention