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

Model Number	FEMTO LDV
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	11/02/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
User reported three patients with observed posterior capsule ruptures.One patient on (b)(6) 2021 (1176) and two patients on (b)(6) 2021 (1214 & 1216.) patients 1176 and 1214 had both anterior and posterior vitrectomies, and all three required a change to sulcus fixated 3 piece iols.

• Brand Name: ZIEMER FEMTO LDV
• Common Device Name: 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: michela peisino ; allmendstrasse 11; port, be, che 2562 ; SZ 2562
• MDR Report Key: 12882813
• Report Number: 3005643720-2021-00018
• Device Sequence Number: 4425984
• Product Code: OOE
• UDI-Device Identifier: 07640167750016
• UDI-Public: (01)07640167750016(11)190121
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K150323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown