Allegro 1X Silicone I/A Tips (1) AT-0001-R-1Recalls & reported problems
Microsurgical Technology, Inc. · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00844685005581), received between May 27, 2025 and May 27, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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
- Insufficient Device Problem Information2
Patient problems
- Capsular Bag Tear2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 27, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
A CAPSULE BREAKAGE WAS NOTED WITH THE MST TIP ON POLISHING. THE PATIENT HAS NOT EXPERIENCED ANY PERMANENT OR TEMPORARY DISORDERS AND THEIR DAILY ACTIVITIES WERE NOT SIGNIFICANTLY AFFECTED. A VITRECTOMY WAS REQUIRED. A DELAY OF FIVE MINUTES OCCURRED DURING THE PROCEDURE AND THE END-USER CONSULTED A DOCTOR BUT HAS NOT BEEN PRESCRIBED ANY MEDICATIONS. FURTHER DETAILS REGARDING THE COMPLAINT ARE EXPECTED TO BE PROVIDED.
Patient problems: Capsular Bag Tear
MAUDE report 22093167 ↗InjuryMay 27, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
A CAPSULE BREAKAGE WAS NOTED WITH THE MST TIP ON POLISHING. THE PATIENT HAS NOT EXPERIENCED ANY PERMANENT OR TEMPORARY DISORDERS AND THEIR DAILY ACTIVITIES WERE NOT SIGNIFICANTLY AFFECTED. A VITRECTOMY WAS REQUIRED. A DELAY OF FIVE MINUTES OCCURRED DURING THE PROCEDURE AND THE END-USER CONSULTED A DOCTOR BUT HAS NOT BEEN PRESCRIBED ANY MEDICATIONS. FURTHER DETAILS REGARDING THE COMPLAINT ARE EXPECTED TO BE PROVIDED.
Patient problems: Capsular Bag Tear
MAUDE report 22092434 ↗
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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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