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); Dry Eye(s) (1814); Foreign Body Sensation in Eye (1869); Red Eye(s) (2038); Visual Disturbances (2140); Eye Pain (4467)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Suspect product discarded.

Event Description

On (b)(6) 2021 a patient (pt) in (b)(6) reported ou irritation, ¿allergic¿, burning sensation, blurry vision, red eye, light sensitivity, foreign body sensation, dry feeling and light sensitivity while wearing the acuvue 2 brand contact lenses (cls) in 2021.The pt went to an eye care provider (ecp) 4-5 times and was prescribed eye drops.The pt would return to cls wear after the prescribed treatments, but the symptoms would reoccur.The pt was prescribed eye drops and asked to suspend cls wear for a ¿few days.¿ the pt is currently wearing a competitor cls with discomfort and is still ¿using eye drops.¿ the pt reports daily cls wear with a 20 to 25-day replacement schedule and reports using opti-free, renu and additional cls solutions (names were not provided).On 23aug2021 the pt provided additional information and prescriptions from the ecp.The pt reported additional symptoms of yellowish discharge, ¿extreme allergy¿, and sensitivity to the sun.The pt went to an additional ecp for a 2nd medical opinion (date not provided).Both ecp¿s advised the pt to suspend use of the acuvue2 cls as it could be the cause of the reported symptoms.Prescription dated (b)(6) 2021: maxidex 1 drop ou every 12 hours for 14 days.Prescription dated (b)(6) 2021, maxiflox-d, 1 drop ou 4x daily for 10 days, the 3x daily for 10 days.Prescription dated (b)(6) 2021: maxidex 1 drop ou 4x daily for 10 days; patanols, continuous use for 90 days, 1 drop ou every 12 hours for 90 days.Prescription dated (b)(6) 2021: hyabak 1drop 6x daily; lastacaft 1drop 1x daily; flutinol 1 drop every 6 hours for 5 days.On 24aug2021 a call was placed to the pts treating ecp.The ecp reported the pt was prescribed maxiflox-d on (b)(6) 2021; diagnosis: bacterial conjunctivitis ou and chronic atopic conjunctivitis ou.The bacterial conjunctivitis resolved (date of resolution was not provided).The pt was treated for multiple events (dates of treatment were not provided) for chronic atopic conjunctivitis which contribute to allergic reaction and cls intolerance.Multiple attempts were made to the pts 2nd treating ecp for additional medical information, but nothing additional has been received.No additional medical information has been received.The pt used 3 different lot #s used, lot # l003xks, lot # b00rdlg and lot # l003xkr.It is unknown which lot # (s) was the suspect product.A lot history review was performed for lot l003xks, lot b00rdlg, and lot l003xkr 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.The 3 lots were produced under normal conditions.The suspect od cl was discarded.No additional evaluation can be conducted.This report is for the pts od event.The report for the pts os event will be submitted in a separate report.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 32256
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433647
• MDR Report Key: 12484797
• MDR Text Key: 271925128
• Report Number: 1057985-2021-00152
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: N18033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/16/2021

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 Catalogue Number: AV2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/24/2021
• Initial Date FDA Received: 09/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention