MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG (JENA) VISUMAX 800; FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION

Model Number	VISUMAX 800
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Visual Impairment (2138); Loss of Vision (2139)
Date of Event	01/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The most likely root cause is a user error.There is indication for a contamination on the contact surface and/or insufficient cleaning of the cornea before surgery which led to the black spots (incomplete cuts).
Event or Problem Description
Patient treated with visumax smile pro was negatively impacted (poor visual acuity) after surgeon decided to proceed to remove the lenticule in the right eye despite the existence of incomplete cuts (black spots).A double plane was created and the lenticule could not be removed completely.

• Brand Name: VISUMAX 800
• Common Device Name: 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: manjaya hegde ; 5300 central parkway; dublin, CA 94568 ; 9252164697
• MDR Report Key: 19121586
• Report Number: 9615030-2024-00011
• Device Sequence Number: 8359920
• Product Code: OTL
• UDI-Device Identifier: 04049471095111
• UDI-Public: (01)04049471095111(11)220901
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: P150040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/16/2024

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: VISUMAX 800
• Device Catalogue Number: 000000-2383-581
• 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: 03/19/2024
• Initial Report FDA Received Date: 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• 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
• Patient Age: 30 YR
• Patient Sex: Female