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

Model Number N/A

Device Problems Contamination (1120); Optical Obstruction (3002); Device Handling Problem (3265)

Patient Problem Unspecified Eye / Vision Problem (4471)

Event Date 01/02/2021

Event Type  Injury  

Manufacturer Narrative

The incident occurred due to incorrect handling of the device.Based on the evaluation of the treatment video, the manufacturer was able to identify dirt particles on the contact glass of the treatment pack.This dirt particle was identified as a fingerprint.The hcp moved the treatment pack for quite long time (approx.15 seconds) lateral on the eye.This increases the risk to pump meibom secret (oily part of the tears) to the surface of the cornea.This secret blocks the laserbeam of the visumax.Therefore, the incision was incomplete.Nevertheless, the lenticule was attempted to be removed by the hcp.This decision is based on a user error.According to the instructions for use, the procedure should be aborted if incomplete cuts are created.

Event Description

A health care professional (hcp) reported that there was an unidentified material on the contact glass of the treatment pack of visumax.The hcp decided to proceed with the surgery.The hcp communicated that dissection was extremely difficult, making proper delineation of the lenticlue almost impossible.As a result a significant volume of the lenticule was torn off and left in the patient's cornea.The current status of the patient is unknown.The hcp will follow up with patient and determine if further treatment is needed.

• Brand Name: VISUMAX
• Type of Device: FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION
• Manufacturer (Section D): CARL ZEISS MEDITEC AG (JENA); carl zeiss promenade 10; jena, thueringia 7745 ; GM 7745
• Manufacturer (Section G): CARL ZEISS MEDITEC AG (JENA); carl zeiss promenade 10; jena, thueringia 7745 ; GM 7745
• Manufacturer Contact: viet nguyen ; 5160 hacienda drive; dublin, CA 94568 ; 9255574689
• MDR Report Key: 11402203
• MDR Text Key: 234406521
• Report Number: 9615030-2021-00005
• Device Sequence Number: 1
• Product Code: OTL
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P150040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• 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: S195179
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/13/2018
• 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