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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MORIA SA CBSU MICROKERATOME
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MORIA SA CBSU MICROKERATOME Back to Search Results
Model Number 19312/130
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Corneal Abrasion (1789)
Event Date 05/17/2023
Event Type  Injury  
Event Description
Healthcare provider reported 'free flap' during lasik surgery.Healthcare provider did not proceed with ablation; repositioned flap and covered w/ contact lens; prk to be scheduled for a later date.Healthcare provider sent in for evaluation: evolution console, single use disposable head, cb turbine, fixation ring, turbine hose and aspiration tubing.Also, sent in surgical data (flap complication report) for evaluation.
 
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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
MDR Report Key17139581
MDR Text Key317291401
Report Number9615659-2023-00001
Device Sequence Number1
Product Code HMY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K981741
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number19312/130
Device Catalogue Number19312/130
Device Lot Number2210501
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/25/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/19/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/07/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
ASPIRATION TUBING REF. 19138; CB 0-RING REF. 19309/0; CB TURBINE REF. 19303; EVOLUTION CONSOLE REF. E0; TURBINE HOSE REF. 19353
Patient Outcome(s) Required Intervention;
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