inforMED
MalfunctionLRX

MAGIK CONTACT LENS CASE (LRX)

Received Jul 5, 2017 · Event occurred Jul 1, 2017

Report MW5070836 · MDR key 6692790

Device

Generic name

Case, Contact Lens

Manufacturer

Unk

Model number

GYL564

Product problems

  • Device Markings/Labelling Problem
  • Inadequate Instructions for Non-Healthcare Professional

Patient

54 YR

  • No Information
  • No Information

Narrative

Description of Event or Problem

I PURCHASED CONTACT LENSES THROUGH (B)(4) THE SELLER IS (B)(4). THE ITEM NAME: MAGIK COLOURFUL CONTACT LENS BOX HOLDER CONTAINER CASE SOAK STORAGE EYECARE KIT GYL564 (20). THE 20 PACKS OF CONTACT LENS CASES DID NOT CONTAIN INDICATIONS, DIRECTIONS FOR USE, WARNINGS, COUNTRY OF MFR OR LOT NUMBER. THIS IS AGAINST FDA REQUIREMENTS FOR CONTACT LENS CASES. (B)(4).