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); Dry Eye(s) (1814); Irritation (1941); Keratitis (1944); Red Eye(s) (2038); Swelling (2091); Excessive Tear Production (2235); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On 05jun2019, an email was received from a patient (pt) in (b)(6) reporting discomfort and ¿a serious allergy¿ while wearing an acuvue® oasys® brand contact lens (cl).On (b)(6) 2019, the pt called and provided additional information: pt reported in (b)(6) 2019, the right eye (od) was very irritated, red, dry, tearing and photophobic upon removal of the cl.On (b)(6) 2019, the pt presented to an eye care provider (ecp) who advised that the ¿od was very irritated and hurt, but it was not an ulcer¿ and there was ¿some bacteria¿.Pt was prescribed vigamox, every 2 hours for the first 2 days, then every 4 hours.Pt reported the redness subsided after 2 days of using the medication.Pt reported continuing to experience od tearing, photophobia and discomfort when blinking.Pt reported a monthly replacement schedule, does not sleep in the cls and used ultrasept to disinfect cls.On (b)(6) 2019, additional information was received from the pt: follow up visit (b)(6) 2019: pt presented to the ecp and the prescription was changed to ster-med (prednisolone), 4 times daily for 10 days until the next return visit (unspecified).Pt reported that the od is better but still swollen.Pt reporting being diagnosed with infectious keratitis od.Pt was requested to consult with 3 specialists for exams - allergenic specialist, ocular motility, and glaucoma.On (b)(6) 2019, an email was received from the pt with additional information: image# (b)(6): image of medication stermd sample image# (b)(6): ecp note dated (b)(6) 2019 requesting allergy service testing image# (b)(6): image of note requesting examination of ocular motility image# (b)(6): ecp note from treating facility dated (b)(6) 2019, "i hereby certify that the patient is undergoing treatment for infective keratitis after use of the gelatinous contact lens on the right eye" image# (b)(6): image of card with eye glass rx.Od -2.00/-0.75/30 image# (b)(6): image of rx from treating facility dated (b)(6) 2019: vigamox 1gtt every 2hrs on od for 2 days then every 4 hrs until second orders.Optive, 1gtt, 4-6 x daily ou.On (b)(6) 2019, the pt provided additional information: pt reported the od is fine now and treatment was discontinued.Pt is not wearing lenses wear per ecp instructions.Pt reported the next follow up visit with the ecp will be in one month.No additional information has been received.The suspect od cl was discarded.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 l003nhn was produced under normal conditions.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. ¿ IRELAND; one technological park plassey; limerick ; EI
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 8735899
• MDR Text Key: 149263129
• Report Number: 9617710-2019-00022
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): Y
• Reporter Country Code: BR
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/05/2019

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 Expiration Date: 07/01/2023
• Device Catalogue Number: PH
• Device Lot Number: L003NHN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/05/2019
• Initial Date FDA Received: 06/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2018
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ULTRASEPT SOLUTION
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 30