MAUDE Adverse Event Report: SIE AG, SURGICAL INSTRUMENT ENGINEERING ZIEMER FEMTO LDV; FEMTO LDV Z8

Model Number FEMTO LDV

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Corneal Edema (1791)

Event Date 09/20/2022

Event Type  Injury  

Event Description

User reported a not further defined corneal damage, observed on (b)(6) 2022 during cataract surgery.Followed by corneal edema, a dmek procedure was performed on the patient`s eye.The device was investigated remotely.No root cause could be established due to the lack of information received further from the site.

Manufacturer Narrative

The device was investigated remotely, no technical problems were found.Further information was requested multiple times from the site, no information nor evidence was provided.Could not confirm complaint.

• Brand Name: ZIEMER FEMTO LDV
• Type of Device: FEMTO LDV Z8
• Manufacturer (Section D): SIE AG, SURGICAL INSTRUMENT ENGINEERING; allmendstrasse 11; port be, che 2562 ; SZ 2562
• Manufacturer (Section G): SIE AG, SURGICAL INSTRUMENT ENGINEERING; allmendstrasse 11; port be, che 2562 ; SZ 2562
• Manufacturer Contact: phd. michela peisino ; allmendstrasse 11; port be, che 2562 ; SZ 2562
• MDR Report Key: 15812882
• MDR Text Key: 303800119
• Report Number: 3005643720-2022-00020
• Device Sequence Number: 1
• Product Code: OOE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FEMTO LDV
• Device Catalogue Number: 510.003.008
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2019
• 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): Required Intervention