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 Inflammation (1932); Iritis (1940); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2020, a patient (pt) in (b)(6) reported inflammation in the left eye (os) while wearing an acuvue® oasys® brand contact lens.In (b)(6) 2020, the pt presented to an eye care provider (ecp) with pain os and was diagnosed with iritis os.The pt was prescribed rinderon drops (unspecified dosage, frequency, duration).The pt was instructed to discontinue contact lens wear until the inflammation resolved and to return to the ecp for follow-up (unspecified date).In (b)(6) 2020, the pt returned to the ecp for follow-up and the os was recovered.There was no further instruction to return or to discontinue lens wear.Currently, the pt has no problem with the os and is wearing daily disposable contact lenses.The pt refused to provide further information.No additional information has been received.No further information is expected.The os suspect product 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 l003t9t 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: 9875150
• MDR Text Key: 195633675
• Report Number: 9617710-2020-00011
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2024
• Device Catalogue Number: PH
• Device Lot Number: L003T9T
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 54 YR