MICOR drive FG-50631Recalls & reported problems
Carl Zeiss Meditec, Cataract Technology, Inc. · Reusable ophthalmic instrument for the removal of cataracts. Connects to MICOR extractor or MICOR vitrector · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00860000122375), received between Nov 19, 2021 and Nov 19, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
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.
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Capsular Bag Tear1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 19, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
A (B)(6) PATIENT UNDERWENT CATARACT SURGERY IN THE LEFT EYE ON (B)(6) 2021 WHERE THE MILOOP AND MICOR LENS FRAGMENTATION SYSTEM (EXTRACTOR AND DRIVE) WERE USED TO FRAGMENT AND REMOVE THE CATARACTOUS LENS. THE PATIENT'S POSTERIOR CAPSULE TORE DURING SURGERY. THERE WAS NO LOSS OF VITREOUS FLUID, NO VITRECTOMY, AND NO CHANGE TO THE INTRAOCULAR LENS IMPLANTED. THE SURGEON REPORTED THE MICOR "FELT RUNNING AT TOO HIGH THROTTLE" AND HE "GOT TOO CLOSE TO THE [CAPSULAR] BAG". THE SURGICAL VIDEO REVEALED THE FOLLOWING ADDITIONAL INFORMATION AND INSIGHT. IT SHOULD BE NOTED THAT THE VIDEO RESOLUTION WAS LOW AND IT WAS NOT POSSIBLE TO IDENTIFY EXACTLY WHEN THE CAPSULAR TEAR OCCURRED. THE PATIENT HAD A DARK IRIS AND A SMALL PUPIL WHICH REQUIRED USE OF AN IRIS RETRACTOR AT THE BEGINNING OF SURGERY. THE MILOOP WAS USED TO BISECT THE PATIENT'S GRADE 3 CATARACTOUS LENS. THERE WERE NO PROBLEMS WITH THE TECHNIQUE USED TO EXECUTE THE MILOOP PROCEDURE. THERE WAS NO EVIDENCE OF A DEVICE MALFUNCTION WITH THE MILOOP OR MICOR DEVICES AND THERE WAS NO EVIDENCE OF AN OVERSPEED CONDITION. BASED ON THE VIDEO EVIDENCE, IT IS POSSIBLE THAT THE IRIS RETRACTOR AND SURGICAL TECHNIQUE DURING ITS REMOVAL AND/OR BAG PO
Patient problems: Capsular Bag Tear
MAUDE report 12845129 ↗
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- Alcon 8065752201Alcon Laboratories, Inc. · Unit, phacofragmentation1 recall386 reports
- Alcon 8065752200Alcon Laboratories, Inc. · Unit, phacofragmentation1 recall366 reports
- Constellation, Ultravit, 25+, TotalPlus, EdgePlus 8065751767Alcon Laboratories, Inc. · Unit, phacofragmentation2 recalls302 reports
- Constellation, ULTRAVIT, Engauge, 25+ 8065752415Alcon Laboratories, Inc. · Unit, phacofragmentation369 reports
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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