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

Catalog Number PH

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

Patient Problems Headache (1880); Pain (1994); Red Eye(s) (2038); Swelling (2091)

Event Date 09/30/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2019, a patient (pt) in (b)(6) reported headache, redness, pain, swelling, and pressure while wearing acuvue® oasys® in the od on (b)(6) 2019.The pt¿s od was red upon removal of the suspect cl.The pt did not seek medical attention.The pt reported using saline to clean and rinse cls.The pt reported a daily wear schedule with monthly replacement.No further information was provided.On (b)(6) 2019, a call was received from the pt stating that the od was still swollen, and the pt has not sought any medical attention.The pt reported wearing an old pair of cls previously reported.The pt¿s od is currently red and swollen.No further information was provided.On (b)(6) 2020, the pt posted a complaint on an on-line website: the pt reported an allergy to the cls.The pt visited an ophthalmologist who advised the allergy was so severe that the pt is at risk of losing vision.The pt alleges 50% vision of the od.The pt is planning an appointment with a specialist for (b)(6) 2020.The pt noted feeling like ¿it is getting worse.¿ on 17feb2020, additional information was received from the pt: the pt did not have the treating eye care provider (ecp) contact information.The pt reported the ecp did not provide a diagnosis but referred the pt to a specialist.No treatment was prescribed.The pt has a specialist visit scheduled for (b)(6) 2020.No further information was provided.This event is being reported as a worst-case event as the diagnosis and treatment were unable to be verified with the treating ecp.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 b00rhlm was produced under normal conditions.Two opened contact lens cases were received containing three contact lenses for lot # b00rhlm.The parameters of the three open lenses were measured, and a visual inspection was performed.The lenses met company standards for power, base curve, center thickness, and diameter.No visual attributes were observed for open contact lens # 1; open contact lens # 2 revealed an edge tear; open contact lens # 3 revealed a surface tear.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

On (b)(6) 2020 the patient (pt) called to the eye care provider (ecp) and advised the lenses caused an allergic reaction and ¿hurt¿ both eyes.The pt reported a follow-up appointment is scheduled to see the ecp on (b)(6) 2020 and will not be able to provide a diagnosis until that appointment.The pt was advised to stop wearing lenses and wasn¿t prescribed any treatment.During the call the pts parent reported the pt will have an exam of the ¿fundus of the eye and that the previous doctor would not let the pt wear glasses until that exam which is scheduled for (b)(6) 2020¿.The parent reported the doctor will determine if they give the pt an eye glass prescription or ¿if the pt will have surgery¿.The parent didn¿t know what kind of surgery was suggested by the ecp.On 03apr2020 an email was received from the pt reporting the ecp appointment on (b)(6) 2020 was postponed and the exam will be rescheduled due to the corona virus.No additional medical information was provided.This report is for the pts od event.A separate report will be submitted for the pts os event.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: ACUVUE OASYS
• Type of Device: LENSES, SOFT CONTACT, EXTENDED WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. ¿ US; 7500 centurion parkway; jacksonville FL
• MDR Report Key: 9779585
• MDR Text Key: 188140088
• Report Number: 1057985-2020-00021
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): Y
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 04/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/01/2023
• Device Catalogue Number: PH
• Device Lot Number: B00RHLM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Date Manufacturer Received: 03/20/2020
• Patient Sequence Number: 1
• Treatment: SALINE
• Patient Outcome(s): Other; Required Intervention