Allegro 1X Silicone I/A Handpiece (6) ASP-0001-RRecalls & reported problems
Microsurgical Technology, Inc. · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00844685006809), received between May 9, 2024 and May 9, 2024 — classified as 4 injuries.
The most frequently reported specific device problem is “Material Frayed” (4 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Frayed4
- Material Protrusion/Extrusion4
Patient problems
- Capsular Bag Tear4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryMay 9, 2024Material Frayed; Material Protrusion/Extrusion; Material Frayed; Material Protrusion/Extrusion
THE DOCTOR EXPERIENCED CAPSULE TEARS USING ALLEGRO SP IA HANDPIECES. FOUR SEPARATE PATIENTS WERE IMPACTED BY 4 DIFFERENT DEVICES. ALL PATIENTS RECOVERED WITH NO INTERVENTION REQUIRED. THE PROCEDURE WAS COMPLETED AS PLANNED.
Patient problems: Capsular Bag Tear
MAUDE report 19283299 ↗InjuryMay 9, 2024Material Frayed; Material Protrusion/Extrusion; Material Frayed; Material Protrusion/Extrusion
THE DOCTOR EXPERIENCED CAPSULE TEARS USING ALLEGRO SP IA HANDPIECES. FOUR SEPARATE PATIENTS WERE IMPACTED BY 4 DIFFERENT DEVICES. ALL PATIENTS RECOVERED WITH NO INTERVENTION REQUIRED. THE PROCEDURE WAS COMPLETED AS PLANNED.
Patient problems: Capsular Bag Tear
MAUDE report 19283298 ↗InjuryMay 9, 2024Material Frayed; Material Protrusion/Extrusion; Material Frayed; Material Protrusion/Extrusion
THE DOCTOR EXPERIENCED CAPSULE TEARS USING ALLEGRO SP IA HANDPIECES. FOUR SEPARATE PATIENTS WERE IMPACTED BY (B)(4) DIFFERENT DEVICES. ALL PATIENTS RECOVERRED WITH NO INTERVENTION REQUIRED. THE PROCEDURE WAS COMPLETED AS PLANNED.
Patient problems: Capsular Bag Tear
MAUDE report 19283297 ↗InjuryMay 9, 2024Material Frayed; Material Protrusion/Extrusion; Material Frayed; Material Protrusion/Extrusion
THE DOCTOR EXPERIENCED CAPSULE TEARS USING ALLEGRO SP IA HANDPIECES. FOUR SEPARATE PATIENTS WERE IMPACTED BY 4 DIFFERENT DEVICES. ALL PATIENTS RECOVERED WITH NO INTERVENTION REQUIRED. THE PROCEDURE WAS COMPLETED AS PLANNED.
Patient problems: Capsular Bag Tear
MAUDE report 19283295 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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