MENICON Z RIGID GAS PERMEABLE (RGP) CONTACT LENS *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-06-22 for MENICON Z RIGID GAS PERMEABLE (RGP) CONTACT LENS * manufactured by Menicon Co. Ltd..

Event Text Entries

[328302] Pt in menicon z rgp contact lens for up to 30 days/29 nights of extended wear was seen by a doctor (o. D. ) in 2004, complaining that the pt awoke with their left lens dislodged from the cornea and that they were experiencing pain on their left eye. The doctor found that the pt had little adhesion mark from the dislodged lens on their left cornea but the pt had 20/20 vision and no cells and flare. The doctor treated the pt with zymar with 4 times a day for 24 hours and a night and day bandage contact lens on that date. The pt was seen again by the doctor in 2004. The pt's left was fine and went back to wear of menicon z rgp contact lens on that date. The pt has not had any problems since then.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3003515967-2004-00004
• MDR Report Key: 546921
• Date Received: 2004-06-22
• Date of Report: 2004-06-11
• Date of Event: 2004-04-08
• Date Facility Aware: 2004-06-11
• Report Date: 2004-06-11
• Date Reported to Mfgr: 2004-06-11
• Date Added to Maude: 2004-10-05
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MENICON Z RIGID GAS PERMEABLE (RGP) CONTACT LENS
• Generic Name: RGP CONTACT LENS
• Product Code: MWL
• Date Received: 2004-06-22
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 536329
• Manufacturer: MENICON CO. LTD.
• Manufacturer Address: * NAGOYA, AICHI JA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2004-06-22