MAUDE Adverse Event Report: MORIA SA ONE USE PLUS MICROKERATOME

Model Number 19345

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

Patient Problem Corneal Abrasion (1789)

Event Date 03/07/2019

Event Type  Injury  

Manufacturer Narrative

This report was the result of a historic review based on company internal corrective & preventive action (b)(4).

Event Description

Healthcare provider reported they had 'partial flap' during lasik surgery, lost suction.Patient is ok, coming back for prk at a later date.One use plus disposable head ref.19337/130 was not saved; sending in one use plus motor ref.19345 for evaluation.

• Brand Name: ONE USE PLUS MICROKERATOME
• Type of Device: ONE USE PLUS MICROKERATOME
• Manufacturer (Section D): MORIA SA; 15 rue georges besse; antony, 92160 ; FR 92160
• Manufacturer (Section G): MORIA SA; 15 rue georges besse; antony, 92160 ; FR 92160
• Manufacturer Contact: bruno chermette ; 15 rue georges besse; antony, 92160 ; FR 92160
• MDR Report Key: 10864137
• MDR Text Key: 217079991
• Report Number: 9615659-2020-00010
• Device Sequence Number: 1
• Product Code: HMY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040297
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 19345
• Device Catalogue Number: 19345
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR