MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ACUVUE OASYS WITH HYDRACLEAR CONTACT LENSES; LENSES, SOFT CONTACT, EXTENDED WEAR

Lot Number B0150TVJ9K

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Blurred Vision (2137); Burning Sensation (2146); Swelling/ Edema (4577)

Event Date 01/12/2024

Event Type  Injury  

Event Description

Purchased acuvue oaysis with hydraclear contact lenses in (b)(6) 2024.Noticed the individual contact packaging looked different (teal versus blue) but otherwise appear the same as what i had been using.There is something different about these lenses.They irritate my eyes after only a few hours wear.They cause itching, burning, minor eyelid swelling, blurry vision, and whether it corresponds or not, intermittent hives on my face.I've never experienced this with this contact brand and type and have worn them nearly exclusively for about 20 years.Google searches for issues or recalls returned multiple forums of individuals experiencing similar issues to mine.

• Brand Name: ACUVUE OASYS WITH HYDRACLEAR CONTACT LENSES
• Type of Device: LENSES, SOFT CONTACT, EXTENDED WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC.
• MDR Report Key: 18817691
• MDR Text Key: 336818805
• Report Number: MW5152245
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Lot Number: B0150TVJ9K
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: CPAP (CONTINUOUS POSITIVE AIRWAY PRESSURE) DEVICE.; FLUOXETINE.; LISDEXAMFETAMINE.; VITAMIN D3.; VITAMIN K2.
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White