MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. 1-DAY ACUVUE MOIST -5.25 BC 8.5; LENSES, SOFT CONTACT, DAILY WEAR

Lot Number 216678 0697

Device Problems Material Puncture/Hole (1504); Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 09/14/2021

Event Type  malfunction  

Event Description

Improperly formed contact lens.Several lenses in this batch had missing material, one had a complete hole, one had a half-moon hole out of the edge of the lens.Others had smaller flaws, often not noticeable until placed on the eye.Fda safety report id # (b)(4).

• Brand Name: 1-DAY ACUVUE MOIST -5.25 BC 8.5
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC.
• MDR Report Key: 12481116
• MDR Text Key: 272127292
• Report Number: MW5103989
• Device Sequence Number: 1
• Product Code: LPL
• Reporter Country Code: US
• PMA/PMN Number: N18033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 216678 0697
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 56 YR