MAUDE Adverse Event Report: ZEISS ZEISS LENS CLEANING WIPE

Lot Number 093G1612

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 04/17/2017

Event Type  malfunction  

Event Description

I purchased a box of zeiss lens cleaning wipes for my eyeglasses.Approx 50% of the wipes are dry and not moistened as declared on the box and the individual packets.I sent an email to customer contact email as indicated on the zeiss website.An email was sent on (b)(6) 2017 without response.I resent the email on (b)(6) 2017.Today is (b)(6) 2017 and i have not received a response from either correspondence.The email that the complaint was sent to is (b)(6).Quantity: 50 packet, frequency: as needed.Date of use: (b)(6) 2017."how was it taken or used: wipes for prescription eyeglass, is the product over-the-counter: yes, did the problem stop after the person reduced the dose or stopped taking or using the product: no, did the problem return if the person started taking or using the product again: yes.".

• Brand Name: ZEISS LENS CLEANING WIPE
• Type of Device: ZEISS LENS CLEANING WIPE
• Manufacturer (Section D): ZEISS
• MDR Report Key: 6717311
• MDR Text Key: 80274809
• Report Number: MW5071004
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/12/2017

1 Device was Involved in the Event

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 Lot Number: 093G1612
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/13/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 49 YR