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 Bacterial Infection (1735); Conjunctivitis (1784); Red Eye(s) (2038)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On 14 jun 2020 a johnson and johnson employee in (b)(6) reported a patient (pt) was diagnosed with a ¿od bacterial infection¿ while wearing an acuvue® oasys® brand contact lens.It was reported that the pt wore the suspect lenses for ¿over a period of approximately 1 month.¿ symptoms of ¿bleeding eye¿, red eye, sensitivity to light were experienced by the pt after 1 month of wearing the suspect lens in the od.The pt went to an ophthalmologist when the symptoms occurred (date of the event is unknown) who removed an eyelash in the od, diagnosed the pt with bacterial infection and prescribed antibiotic eye drops (name of antibiotic and frequency were not provided).The symptoms improved after treatment.On 16 jun 2020 additional information was provided: the reporter advised that the pt stated the ¿doctor spoke of conjunctivitis, but the pt doesn't know if the infection was caused by the lens.¿ the pt was prescribed ofloxacin tid for 5 days.The pt has returned to contact lens wear after approximately 3 weeks with no permanent damage noted to the od.The reporter advised no additional information is known.No additional medical information is expected.The date of the event is reported as 2020.This od event is being reported as a worst-case event as the diagnosis and treatment were unable to be verified with the pt's treating doctor.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 l003w46 was produced under normal conditions.The suspect od contact lens was discarded.No additional investigation can be conducted.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; one technological park plassey; limerick ; EI
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 10247407
• MDR Text Key: 201054853
• Report Number: 9617710-2020-00014
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/01/2024
• Device Catalogue Number: PH
• Device Lot Number: L003W46
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 31