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); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On 10aug2020 a patient (pt) called to report ocular discomfort that didn¿t resolve while wearing the acuvue® oasys® brand contact lenses.The pt also reported spots on the contact lens upon removal and would clean the lenses.The pt stated the suspect lenses would tear during cleaning, but the spots remained.The pt discontinued contact lens wear ¿for a while¿ and went to an eye care provider (ecp) for the issue.On 18aug2020 the pt called to provide additional information.The pt reported discomfort within 20 minutes of contact lens wear.The ecp diagnosed with pt with a bacterial eye infection and discontinued contact lens wear for 2 weeks.The pt was prescribed an antibacterial eye drop (name of eye drop was unknown) and advised the event was resolved.The pt reported daily contact lens wear, with a 2-3 week contact lens replacement schedule and uses opti-free to clean the lenses.On 18aug2020 a call was placed to the pts treating ecp for additional medical information.The ecp reported the pt was diagnosed with os bacterial infection (date of visit not provided).The pt was prescribed ocuflox tid for 14 days, but the pt used ou as a precaution.The pt was seen for a follow-up (date was not provided) and the event was resolved.The date of the event is unknown.No additional medical information was provided.No additional medical information is expected.The lot number is unknown.The os suspect lens was discarded by the pt.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; 7500 centurion parkway; jacksonville FL
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 10508811
• MDR Text Key: 206312371
• Report Number: 1057985-2020-00048
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): Y
• 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: Other
• Type of Report: Initial
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• 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: UNK-PH
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention