MAUDE Adverse Event Report: MORIA SA CBSU MICROKERATOME

Model Number 19312/110

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

Patient Problem Keratitis (1944)

Event Date 03/04/2021

Event Type  Injury  

Event Description

Healthcare provider reported that patient had dlk on (b)(6) 2021 (had two other similar incidents recently).Healthcare provider will send in (2) unused cb disposable heads, (2) cb turbines & (2) cb ring sets for evaluation; the disposable heads lot 2190303 involved in the surgery were not saved.Healthcare provider will discard (non-moria) cannulas used in surgery and purchase new cannulas.

• 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: 11624334
• MDR Text Key: 244168188
• Report Number: 9615659-2021-00003
• 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: 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: 12/20/2023
• Device Model Number: 19312/110
• Device Catalogue Number: 19312/110
• Device Lot Number: 2190303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Date Manufacturer Received: 03/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2019
• 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