MAUDE Adverse Event Report: MORIA SA M2SU MICROKERATOME

Model Number 19334/130

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Corneal Abrasion (1789)

Event Date 02/12/2021

Event Type  Injury  

Event Description

Healthcare provider reported they had button hole during lasik surgery.Disposable head ref.19334/130 was discarded; sending m2 motors ref.19326 s/n (b)(4) and (2) m2 rings ref.19325/0 for evaluation.Patient is scheduled for prk at a later date.

• Brand Name: M2SU MICROKERATOME
• Type of Device: M2SU MICROKERATOME
• Manufacturer (Section D): MORIA SA; 15 rue georges besse; antony, 92160 ; FR 92160
• MDR Report Key: 11624512
• MDR Text Key: 255502888
• Report Number: 9615659-2021-00004
• Device Sequence Number: 1
• Product Code: HMY
• Combination Product (y/n): N
• PMA/PMN Number: K022560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2024
• Device Model Number: 19334/130
• Device Catalogue Number: 19334/130
• Device Lot Number: 2191602
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention