MAUDE Adverse Event Report: VORTEX SURGICAL INC. VORTEX SURGICAL; OPHTHALMIC ILLUMINATED LASER PROBE

Model Number	VS0135.25
Medical Device Problem Code	Accessory Incompatible (1004)
Health Effect - Clinical Code	Unspecified Eye / Vision Problem (4471)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After an investigation we have determined that some tips have abnormalities that may prevent insertion into a 25ga cannula or provide resistance removing the device from the cannula.Production and quality control have been made aware of the issue to help prevent reoccurrence.Devices are 100% checked on canula compatibility prior to release.The assembly lot 040-2509-288 that may be affected containing 295 assemblies.These 295 assemblies were used in one finished good sterile lot (2509040) containing 59 boxes.We have recalled all 59 boxes.
Event or Problem Description
Surgeon had difficulty getting vs0135.25 illuminated flex-tip laser probe to pass through transition of the cannula.Cannula pulled out of the eye.No patient harm noted by surgeon.

• Brand Name: VORTEX SURGICAL
• Common Device Name: OPHTHALMIC ILLUMINATED LASER PROBE
• Manufacturer (Section D): VORTEX SURGICAL INC.; 4 research park dr; suite 124; st. charles MO 63304
• Manufacturer (Section G): VORTEX SURGICAL INC.; 4 research park dr; suite 124; st. charles MO 63304
• Manufacturer Contact: andrew ritts ; 4 research park dr; suite 124; st. charles, MO 63304 ; 6367784350
• MDR Report Key: 24078620
• Report Number: 3013002167-2026-00003
• Device Sequence Number: 5828038
• Product Code: HQB
• UDI-Device Identifier: 00810123483549
• UDI-Public: (01)00810123483549(17)281001(10)2509040
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K220263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 01/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VS0135.25
• Device Catalogue Number: VS0135.25
• Device Lot Number: 2509040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown