MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ACUVUE 1-DAY MOIST WITH LACREON, DIA 14.2 D -4.00, BC 8.5; LENSES, SOFT CONTACT DAILY WEAR

Lot Number 2159540383

Device Problem Material Integrity Problem (2978)

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

Event Date 04/01/2019

Event Type  malfunction  

Event Description

Contact lens was dry within unopened package.Fda safety report id# (b)(4).

• Brand Name: ACUVUE 1-DAY MOIST WITH LACREON, DIA 14.2 D -4.00, BC 8.5
• Type of Device: LENSES, SOFT CONTACT DAILY WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC.
• MDR Report Key: 8500402
• MDR Text Key: 141659029
• Report Number: MW5085726
• Device Sequence Number: 1
• 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
• Type of Report: Initial
• Report Date: 04/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/01/2023
• Device Lot Number: 2159540383
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 100