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

Catalog Number 000000-1345-518

Device Problems Application Program Problem: Parameter Calculation Error (1449); Application Program Problem (2880)

Patient Problem Not Applicable (3189)

Event Date 11/07/2018

Event Type  malfunction  

Manufacturer Narrative

A device evaluation was not performed since the issue was confirmed to be a software defect in version 2.10.13.

Event Description

A defect in the smile option of software (sw) version 2.10.13 was reported during a wet-lab application training using porcine eyes.If suction loss occurs in phase 2 of the treatment, the software allows the user to choose the option immediate restart or restart treatment.The software offers a flap cut, but due to the software issue, it performs a cap cut instead of a flap cut if the user proceeds.In the case that the user does not recognize the missing side cut of the flap and tries to lift the flap, the patient's cornea could be harmed.

• Brand Name: VISUMAX FEMTOSECOND LASER
• Type of Device: FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION
• Manufacturer (Section D): CARL ZEISS MEDITEC AG (JENA); carl zeiss promenade 10; jena, thueringia 07745 ; GM 07745
• Manufacturer (Section G): CARL ZEISS MEDITEC AG (JENA); carl zeiss promenade 10; jena, thueringia 07745 ; GM 07745
• Manufacturer Contact: vernon brown ; 5160 hacienda drive; dublin, CA 94568 ; 9255574616
• MDR Report Key: 8142799
• MDR Text Key: 130489518
• Report Number: 9615030-2018-00012
• Device Sequence Number: 1
• Product Code: OTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 000000-1345-518
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/08/2015
• 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