MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ACUVUE OASYS WITH HYDRALUXE 8.5 LENSES, SOFT CONTACT, DAILY WEAR

Lot Number J002LSM 0M1

Device Problem Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 01/10/2022

Event Type  malfunction  

Event Description

This has now happened about a dozen times with this batch. Wrinkled edges that are extremely uncomfortable that i needed to use new ones. Fda safety report id # (b)(4).

• Brand Name: ACUVUE OASYS WITH HYDRALUXE 8.5
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC.
• MDR Report Key: 13251249
• MDR Text Key: 283948402
• Report Number: MW5106620
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/10/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Lot Number: J002LSM 0M1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No Answer provided