MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG (JENA) VISUMAX LASER KERATOME; FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Visual Impairment (2138)

Event Type  Injury  

Manufacturer Narrative

Customer did not allege device malfunction.No device problem found related to the adverse event.The device is maintained regularly.Last preventive maintenance was performed end of september 2020.Root cause is not clear.The customer has refused a device evaluation.No further investigation is possible since the customer has not provided further information regarding the event.The actual incident date is not known, only the incident year, which is 2020.

Event Description

A healthcare professional (hcp) reported that a patient was diagnosed with central cornea island after being treated with a visumax device.

• Brand Name: VISUMAX LASER KERATOME
• Type of Device: FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION
• Manufacturer (Section D): CARL ZEISS MEDITEC AG (JENA); rudolf-eber-strasse 11; oberkochen, baden-wuerttemberg 73447 ; GM 73447
• Manufacturer (Section G): CARL ZEISS MEDITEC AG (JENA); carl zeiss promenade 10; jena, thueringia 07745 ; GM 07745
• Manufacturer Contact: viet nguyen ; 5160 hacienda drive; dublin, CA 94568 ; 9255574151
• MDR Report Key: 10901525
• MDR Text Key: 218215194
• Report Number: 9615030-2020-00017
• Device Sequence Number: 1
• Product Code: OTL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P150040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 000000-1345-518
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2016
• 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