MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. ACUVUE OASYS BRAND CONTACT LENS; LENSES SOFT CONTACT, DAILY WEAR

Lot Number L003G463WL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/07/2019

Event Type  malfunction  

Event Description

Received expired contact lenses for my daughter from (b)(6).Manufacturer: johnson and johnson vision care, (b)(4), usa seller.(b)(6); product: acuvue oasys brand contact lens, order number: 174215, lot and expiry date:lot # l003g4633wk, 2018-01-05; lot # l003n6t3k4, 2018-7-11; lot # l0033n6t3kg, 2018-7-11; lot # l003n6t3jb, 2018-07-11; lot # l003g463wl, 2018-01-05; lot # l003g463wl, 2018-01-05.The lens were received today.

• Brand Name: ACUVUE OASYS BRAND CONTACT LENS
• Type of Device: LENSES SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.
• MDR Report Key: 8231576
• MDR Text Key: 132911707
• Report Number: MW5082987
• Device Sequence Number: 5
• Product Code: LPL
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 01/07/2019
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/05/2018
• Device Lot Number: L003G463WL
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21 YR
• Patient Weight: 37