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

Catalog Number PH

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

Patient Problems Bacterial Infection (1735); Conjunctivitis (1784); Irritation (1941); Red Eye(s) (2038); Burning Sensation (2146)

Event Date 04/10/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On 23may2019 an email was received from a patient (pt) in (b)(6) who reported experiencing irritation and ¿gave bacteria¿ after replacing with new acuvue oasys brand contact lenses (cl).On (b)(6) 2019, the pt first experienced burning sensation, and redness on removal of cls.The pt reported the issues occurred with 2 lenses, each eye, with the left eye (os) symptoms worse than the right eye (od).The pt went to the eye care provider (ecp) 4-5 times for the reported event.The pt requested the medical reports from the treating ecp and will send the medical information as it is received.The pt was prescribed eye drops, but the name of eye drop was not provided.The pt advised that both eyes are currently fine.The pt has not returned to contact lens wear and is currently wearing glasses.The pt uses opti-free solution to disinfect the lenses.Pt reported daily wear schedule with a monthly lens replacement schedule.On (b)(6) 2019 an email was received from the pt with additional information.Prescription dated (b)(6) 2019 for vigamox 1 drop both eyes (ou) every 3 hours.Prescription dated (b)(6) 2019 for optive 1 drop ou every 2 hours.Prescription dated (b)(6) 2019 for optive 1 drop ou every 3 hours and epitegel 1 drop ou at night.Work excuse dated (b)(6) 2019 ¿ excused until (b)(6) 2019, icd code h100 (mucopurulent conjunctivitis).No additional medical information has been received.The suspect product was requested for return for evaluation, but it has not yet been received.This report is for the left eye (os) event.A separate report will be filed for the right eye (od) event.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 l00394z was produced under normal conditions.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

Two opened lens cases were received containing three lenses lot # l00394z.The parameters of the three lenses were measured and a visual inspection was performed.The lens met company standards for base curve, center thickness and diameter.The microscopic visual exam for lens # one and # three revealed no attributes.Lens # two revealed spots.The product was returned opened and it is not known what external influences may have contributed to the evaluation results.This report is for the left eye (os) event.A separate report will be filed for the right eye (od) event.If any further relevant information is received, a supplemental report will be filed.Section h ¿ 6: code 10 ¿ testing of actual/suspected device.

• Brand Name: ACUVUE OASYS
• Type of Device: LENSES, SOFT CONTACT, EXTENDED WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND; one technological park plassey; limerick ; EI
• MDR Report Key: 8708146
• MDR Text Key: 148307668
• Report Number: 9617710-2019-00018
• 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,health profe
• Type of Report: Initial,Followup
• Report Date: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2022
• Device Catalogue Number: PH
• Device Lot Number: L00394Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Date Manufacturer Received: 08/01/2019
• Patient Sequence Number: 1
• Treatment: OPTI-FREE.; OPTI-FREE
• Patient Outcome(s): Other; Required Intervention