MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. - US ACUVUE OASYS MULTIFOCAL; LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number FAL

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

Patient Problems Itching Sensation (1943); Local Reaction (2035); Red Eye(s) (2038); Eye Pain (4467)

Event Date 09/26/2021

Event Type  Injury  

Manufacturer Narrative

Requested but not yet received.

Event Description

On 05oct2021 a patient (pt) in (b)(6) sent an email to report a diagnosis of anaphylactic shock while wearing the acuvue oasys® multifocal brand contact lenses (cls).The pt reported ou discomfort approximately fours after insertion of new pair of trial lenses.On removal of the suspect ou cls, the pt experienced ou itching, redness, inflammation, throat constriction, then respiratory distress on (b)(6) 2021.The pt went to the emergency room (er) and was diagnosed with anaphylactic shock.The pt has a known latex allergy.On 06oct2021 an email was sent to the pt to advise that no latex products are included in the acuvue brand contact lenses.On 06oct2021 an email was received from the pt who will check the lens materials with the immunologist to see if any material may have possibly produced the anaphylaxis.On 06oct2021 the pts hospital discharge paperwork was received.Date of visit: (b)(6) 2021.The pt is allergic to latex, ¿caines¿ and erythromycin.The pt reported after trying multifocal contact lens, developed a facial rash, dysphonia, and difficulty breathing.The pt self-medicated with prednisone and bilidren (dehydrocholic acid) without response.The pt then presented to the er with symptoms of anaphylaxis.Adrenalin, corticoids, and antihistamines were administered.The pt was admitted to hospital for observation and management.Admitting diagnosis: anaphylactic reaction; latex allergy, chronic history summary of 24-hour clinical evolution, studies, and treatments: general tests were requested.The testing highlighted a slight alteration of creatinine that improved to normal with the use of steroids and antihistamines.The pt had a good clinical response.The pt was evaluated by the immunology team; advanced studies is agreed with tryptase, total and specific ige to latex and isac.The pt is advised to continue bilidren until outpatient follow-up for adjustment.Given the pt had a good response and the possibility of maintaining outpatient management, the patient was discharged with strict instructions.Patient condition at time of discharge ¿ improved.Diagnosis at time of discharge: anaphylactic reaction; chronic medical history; bariatric surgery.Principal diagnosis: anaphylactic shock ¿ not specified.Patient discharged (b)(6) 2021.Discharge instructions: relative rest, normal regimen/activities, continue chronic medications, bilidren 20mg every 12 hours by mouth, follow up with doctor or immunologist with test results that will be ready in 30 days, call with any questions, epipen prescription given if symptoms return or the patient experiences fever, intense headache, hemorrhage, or sharp pain-consult your health care provider or our emergency service.No additional medical information has been received.Latex is not used in any acuvue® brand lens materials, polypropylene blister pack, or labelling material.There is no latex in the manufacturing process or on the manufacturing equipment.Also, latex gloves are not used in manufacturing.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 b00w16x was produced under normal conditions.The suspect od cls was requested for return for evaluation but it has not yet been received.This report is for the pts od.The report for the pts os will be submitted in a separate report.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: ACUVUE OASYS MULTIFOCAL
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. - US; 7500 centurion parkway; jacksonville FL 32256
• Manufacturer Contact: richard holmes ; 7500 centurion parkway; jacksonville, FL 32256 ; 9548020487
• MDR Report Key: 12666152
• MDR Text Key: 277919109
• Report Number: 1057985-2021-00162
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K200243
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: FAL
• Device Lot Number: B00W16X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2020
• 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
• Patient Age: 47 YR