MAUDE Adverse Event Report: MORIA SA CBSU MICROKERATOME

Model Number 19309/0

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

Patient Problem Corneal Abrasion (1789)

Event Date 10/27/2020

Event Type  Injury  

Manufacturer Narrative

Additional surgical/clinical informational was requested: but not supplied by the health professional.

Event Description

Healthcare provider reported recently had thin flaps; believes problem may be with rings.Confirmed dr.Is using moria's nomogram.All customers equipment was last serviced (b)(6) 2020, will send rings back for evaluation.One thin flap resulted in pseudo buttonhole, completion of surgery will be later in (b)(6).Disposable head was not saved.

• Brand Name: CBSU MICROKERATOME
• Type of Device: CBSU MICROKERATOME
• Manufacturer (Section D): MORIA SA; 15 rue georges besse; antony, 92160 ; FR 92160
• MDR Report Key: 11417482
• MDR Text Key: 238593516
• Report Number: 9615659-2021-00002
• Device Sequence Number: 1
• Product Code: HMY
• Combination Product (y/n): N
• PMA/PMN Number: K981741
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 19309/0
• Device Catalogue Number: 19309/0
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Date Manufacturer Received: 02/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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