MAUDE Adverse Event Report: MORIA SA CBSU MICROKERATOME

Model Number 19312/130

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

Patient Problem Corneal Abrasion (1789)

Event Date 04/23/2021

Event Type  Injury  

Event Description

Healthcare provider reported partial flap during lasik surgery.Healthcare provider sent in disposable cbsu head, cb turbine and (4) o-rings for evaluation.Also, sent in surgical data (flap complication report and patient treatment plan) for evaluation.Prk scheduled for a later date.

• 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: 11901176
• MDR Text Key: 253156833
• Report Number: 9615659-2021-00005
• 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: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 19312/130
• Device Catalogue Number: 19312/130
• Device Lot Number: 2192101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Date Manufacturer Received: 05/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2019
• 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
• Treatment: CB 0-RING REF. 19309/0; CB TURBINE REF. 19303
• Patient Outcome(s): Other