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

Model Number VISUMAX

Device Problem Use of Device Problem (1670)

Patient Problem Visual Impairment (2138)

Event Date 09/25/2023

Event Type  Injury  

Manufacturer Narrative

The most possible root cause is a user error.There was too much liquid on the eye.As a consequence, the lenticule cut on the upper part is not sharp and not clearly defined which explains the difficult dissection.There is no indication that there was a malfunction of the zeiss device that contributed to the complications during lenticule removal.With the current information, there is no indication of any malfunction of the zeiss device which could have contributed to the reported surgical outcome.

Event Description

It was reported by the surgeon that there was a complication with a lenticule removal, and sticky dissection.Lenticular interface was extremely sticky ; one quarter of side cut appeared to be missing.The doctor mentioned an injury: irregular astigmatism on patient cornea.

• 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 7745 ; GM 7745
• Manufacturer (Section G): CARL ZEISS MEDITEC AG (JENA); carl zeiss promenade 10; jena, thueringia 7745 ; GM 7745
• Manufacturer Contact: manjaya hegde ; 5300 central parkway; dublin, CA 94568 ; 9252164697
• MDR Report Key: 17997105
• MDR Text Key: 326411382
• Report Number: 9615030-2023-00008
• Device Sequence Number: 1
• Product Code: OTL
• UDI-Device Identifier: 04049471095036
• UDI-Public: (01)04049471095036(11)210101
• 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: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VISUMAX
• Device Catalogue Number: 000000-1345-518
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2021
• 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