MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG (JENA) VISUMAX; VISUMAX LASER KERATOME

Catalog Number	000000-1345-518
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	04/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the device evaluation results the visumax worked within specification.The manufacturer determined that the root cause of the event is user error.There was no device malfunction.Based on the provided information, there is no evidence to indicate the presence of a potential quality issue with respect to manufacturing, design, or labeling.The instructions for use (ifu) informs the user about potential risks like retained lenticule and incomplete removal of lenticule.It advises the user to ensure that the entire lenticule has to be removed.The ifu informs about possible side effects like a retained lenticule and incomplete removal of lenticule.
Event or Problem Description
A health care professional (hcp) reported that a patient may have retained lenticule fragment, and his vision is decreasing.

• Brand Name: VISUMAX
• Common Device Name: VISUMAX LASER KERATOME
• 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: 21998874
• Report Number: 9615030-2025-00011
• Device Sequence Number: 12967613
• Product Code: HQF
• UDI-Device Identifier: 04049471095036
• UDI-Public: (01)04049471095036(11)190901
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K100253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/09/2025

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 Catalogue Number: 000000-1345-518
• 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: 04/10/2025
• Initial Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown