MAUDE Adverse Event Report: MORIA SA CBSU MICROKERATOME

Model Number 19309/0, 19309/-1

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Failure to Clean Adequately (4048)

Patient Problem Keratitis (1944)

Event Date 01/23/2023

Event Type  Injury  

Manufacturer Narrative

Although a cleaning issue is identified, dlk is possibly an environmental issue and therefore conclusion can not be established.

Event Description

Healthcare provider reported getting dlk.Last two months of surgeries getting couple cases every round of surgeries.Healthcare provider sent in (2) turbines & (4) rings (2 ea 19309/0 & 19309/-1) for evaluation; does not see visible rust but wants inspection.Healthcare provider reviewing possible environmental causes: or filters & vents; instrument cleaning protocol; office mold; hvac system; etc.

Event Description

Supplemental / follow-up report to 9615659-2022-00002.Healthcare provider reported office was treated for mold contamination and switched sterilizer from dry heat back to autoclave.Dlk issue is now significantly better; now experiencing only occasional mild dlk to periphery of flap.Healthcare provider sent in (4) rings (2 ea 19309/0 & 19309/-1) for evaluation.

Manufacturer Narrative

2/20/23 healthcare provider stated dlk issue is not resolved and will continue to look into additional environmental solutions.Dlk can be caused by many factors not especially linked to moria medical devices.A document "complications of lasik, part 3 - diffuse lamellar keratitis" was sent to the healthcare provider.

• Brand Name: CBSU MICROKERATOME
• Type of Device: CBSU 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: 16042429
• MDR Text Key: 306073729
• Report Number: 9615659-2022-00002
• Device Sequence Number: 1
• Product Code: HMY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981741
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 19309/0, 19309/-1
• Device Catalogue Number: 19309/0, 19309/-1
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2023
• 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
• Treatment: CB SINGLE USE HEAD REF. 19312/XXX; CB SINGLE USE HEAD REF. 19312/XXX; CB TURBINE REF. 19303; CB TURBINE REF. 19303; EVOLUTION 3E CONSOLE REF. E0; EVOLUTION 3E CONSOLE REF. E0
• Patient Outcome(s): Required Intervention