MAUDE Adverse Event Report: JOHNSON AND JOHNSON VISION CARE, INC. JOHNSON AND JOHNSON VISION CARE 1-DAY ACUVUE MOIST MULTIFOCAL WITH LACREON; LENSES, SOFT CONTACT, DAILY WEAR

Lot Number 158332 0104C

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 09/27/2018

Event Type  malfunction  

Event Description

I was trialing a contact lens and the dr had provided samples for a few weeks.I had 2 issues: one of the contact lenses was dry and had completely adhered to the side of the plastic.(there was no solution in it at all, so it either leaked or was never filled); in another box, when you pull back the foil, it would pull back on the other attached lenses.

• Brand Name: JOHNSON AND JOHNSON VISION CARE 1-DAY ACUVUE MOIST MULTIFOCAL WITH LACREON
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): JOHNSON AND JOHNSON VISION CARE, INC.
• MDR Report Key: 7969085
• MDR Text Key: 123979939
• Report Number: MW5080574
• 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: 10/12/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/01/2023
• Device Lot Number: 158332 0104C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Weight: 70