MORIA LSK ONE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-11-16 for MORIA LSK ONE manufactured by Moria.

Event Text Entries

[17729485] Paracentral/central toxic keratopathy. I have personally examined 3 pts, and am aware of about 3 more. I have seen these pts in consultation, after they were referred to me by their lasik surgeon. All pts underwent uncomplicated lasik surgery using the moria lsk one disposable microkeratome and subsequently developed a severe central/paracentral "toxic keratopathy", associated with severe, medically recalcitrant diffuse lamellar keratitis which, in some cases was treated with flap lifting and irrigation. Most cases were bilateral, yet asymmetric. Most cases resulted in flap thinning, with scar tissue, and irregular astigmatism, resulting in permanent visual loss. My understanding is that this matter has been brought to the attention of the manufacturer. No public announcements have been made, in spite of the fact that this has occurred in multiple disparate locations. Apparently the problem was finally resolved by rinsing the turbines in alcohol or something to that effect. The surgeon who referred the cases to me has chosen not to report these cases formally to the fda, so i do not have any more specific info.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5013571
• MDR Report Key: 1532048
• Date Received: 2009-11-16
• Date of Report: 2009-11-06
• Date of Event: 2008-09-01
• Date Added to Maude: 2009-11-20
• Event Key: 0
• Report Source Code: Voluntary 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: 0
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MORIA LSK ONE
• Generic Name: DISPOSABLE MICROKERATOME
• Product Code: HMY
• Date Received: 2009-11-16
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MORIA

Patients

Patient Number	Treatment	Outcome	Date
1	0		2009-11-16