MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG (OBERKOCHEN) ARTEVO 750/850; OPHTHALMIC SURGICAL MICROSCOPE

Model Number	6649
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); Phototoxicity (2165)
Date of Event	04/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A health care professional (hcp) reported that a patient developed phototoxicity from a vitrectomy surgery involving the use of an artevo 750 / 850.The case was about 1:45 hours in length and no unusual medications were used.The patient had a straightforward vitrectomy without complications or even contact with the macular surface.However, about 1 month postop, the patient has paracentral vision changes as well as changes to the ellipsoid zone on ocular coherence tomography.
Additional Manufacturer Narrative
The reported issue seems to stem from the use of endo-illumination in a complex vitrectomy procedure rather than a malfunction of the artevo 750 microscope.
Additional Manufacturer Narrative
Field b4: date of this report field d4: added "model number (6649) and udi number (b)(4)." field d9: updated to "yes" field g3: updated "date received by manufacturer" 05/30/2025 field g6: updated to "follow-up # 1" and "30-day" field h2: selected correction to add "device evaluation summary" and "additional information" to add the model number and the udi number.Field h3: updated to "yes".Field h11: added description of changes.
Additional Manufacturer Narrative
Field b3: corrected "date of event" from 04/30/2025 to 04/01/2025.Field g6: updated to "follow-up # 2" and "30-day".

• Brand Name: ARTEVO 750/850
• Common Device Name: OPHTHALMIC SURGICAL MICROSCOPE
• Manufacturer (Section D): CARL ZEISS MEDITEC AG (OBERKOCHEN); rudolf-eber-strasse 11; oberkochen, baden-wuerttemberg 73447 ; GM 73447
• Manufacturer (Section G): CARL ZEISS MEDITEC AG (OBERKOCHEN); rudolf-eber-strasse 11; oberkochen, baden-wuerttemberg 73447 ; GM 73447
• Manufacturer Contact: manjaya hegde ; 5300 central parkway; dublin, CA 94568 ; 9252164697
• MDR Report Key: 22115938
• Report Number: 9615010-2025-00010
• Device Sequence Number: 4122862
• Product Code: HRM
• UDI-Device Identifier: 04049539066497
• UDI-Public: 4049539066497
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2025

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 Model Number: 6649
• 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: 04/30/2025
• Supplement Date Received by Manufacturer: 05/30/2025; Not provided
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 05/30/2025; 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2024
• 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; Disability
• Patient Sex: Unknown