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 Corneal Ulcer (1796); Dry Eye(s) (1814); Iritis (1940); Eye Pain (4467)

Event Date 01/21/2021

Event Type  Injury  

Manufacturer Narrative

Suspect product discarded.

Event Description

On 15mar2021 a pt reported the centers of the acuvue® oasys with hydraclear® plus technology brand contact lenses (cls) became foggy and dry, causing eyes to hurt and not being able to see with at least 8-10 cls, since (b)(6).On 16mar2021 additional information was received from the pt.The pt reported visiting a ¿specialist¿ who diagnosed a corneal ulcer in the right eye (od) a few weeks ago.The pt was prescribed antibiotic drops (unknown name), 2 drops bid, and then steroid drops (unknown name), 2 drops bid, then the dosage "dwindled down.¿ the pt returned to cls wear (date not provided) while continuing to experience symptoms and did not seek medical attention at that time.The pt refused to have the treating specialist contacted.The pt uses opti-free solution to clean cls.The pt reported the od is currently fine and is wearing glasses.On 16mar2021 a representative of the prescribing eye care provider (ecp) reported the pt was referred to a specialist on (b)(6) 2021 for corneal ulcer and iritis od.No further information was provided.No additional information has been received.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 b00v383 was produced under normal conditions.The suspect od cl was discarded.No further 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; 7500 centurion parkway; jacksonville FL 32256
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433647
• MDR Report Key: 11630006
• MDR Text Key: 261110020
• Report Number: 1057985-2021-00123
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: PH
• Device Lot Number: B00V383
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 32 YR