MICS SIL I/A HDP 45° STELL 12B 85915STRecalls & reported problems
Bausch & Lomb GmbH · Single Use Medical Device for Ophthalmic Surgery · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04058935000516), received between Sep 25, 2023 and Feb 19, 2026 — classified as 3 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Particulates” (3 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
- Particulates3
- Adverse Event Without Identified Device or Use Problem2
- Detachment of Device or Device Component1
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Capsular Bag Tear2
- Endophthalmitis1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem
THE USER FACILITY IN AUSTRALIA REPORTED DURING THE POLISHING PORTION OF A CATARACT PROCEDURE, POSTERIOR CAPSULE (PC) TEAR OCCURRED. DUE TO THE PC TEAR AND THE NEED FOR VITRECTOMY, SURGERY WAS EXTENDED BY APPROXIMATELY 20 MINUTES, REQUIRING EXTRA TOPICAL ANESTHETIC. NO EXTRA MEDICATIONS OR TREATMENTS WERE NEEDED. PATIENT WAS REVIEWED THE FOLLOWING DAY, (B)(6) 2026, AND NO ADVERSE OUTCOMES WERE REPORTED.
Patient problems: Capsular Bag Tear
MAUDE report 24391095 ↗MalfunctionOct 25, 2024Particulates; Particulates
THE USER FACILITY IN THE UNITED KINGDOM REPORTED THE SURGEON NOTICED FIBERS FOUND ON THE I/A HANDPIECE WERE IN THE ANTERIOR CHAMBER. NO MEDICAL INTERVENTION/TREATMENT REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20532335 ↗MalfunctionOct 15, 2024Particulates; Particulates
THE USER FACILITY IN UNITED KINGDOM REPORTED PLASTIC FIBERS WERE COMING OFF THE I/A HANDPIECES (BLUE PLASTIC TIPS) ON TWO PATIENTS. NO MEDICAL INTERVENTION/TREATMENT WAS REQUIRED OTHER THAN REMOVING THE FIBERS FROM THE PATIENTS EYE. THE SURGERY INCREASE DURATION WAS 0-15 MINUTES. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20450925 ↗MalfunctionOct 15, 2024Particulates; Particulates
THE USER FACILITY IN UNITED KINGDOM REPORTED PLASTIC FIBERS WERE COMING OFF THE I/A HANDPIECES (BLUE PLASTIC TIPS) ON TWO PATIENTS. NO MEDICAL INTERVENTION/TREATMENT WAS REQUIRED OTHER THAN REMOVING THE FIBERS FROM THE PATIENTS EYE. THE SURGERY INCREASE DURATION WAS 0-15 MINUTES. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20450875 ↗InjurySep 28, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
THE USER FACILITY IN THE UNITED KINGDOM REPORTED A PATIENT DEVELOPED AN INFECTION IN THEIR EYE AND DIAGNOSED WITH ENDOPHTHALMITIS. MEDICAL INTERVENTION: POST OPERATION MEDICATION.
Patient problems: Endophthalmitis
MAUDE report 17838556 ↗InjurySep 25, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY IN THE UNITED KINGDOM REPORTS THAT A SPLIT WAS IDENTIFIED IN THE TIP OF THE IA HANDPIECE FOLLOWING A CATARACT PROCEDURE THAT RESULTED IN A POSTERIOR CAPSULAR RUPTURE. PATIENT RECEIVED AN ANTERIOR VITRECTOMY.
Patient problems: Capsular Bag Tear
MAUDE report 17806473 ↗
Other Unit, Phacofragmentation devices
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- Centurion 8065753057Alcon Laboratories, Inc. · Unit, phacofragmentation639 reports
- CENTURION® 8065752914Alcon Laboratories, Inc. · Unit, phacofragmentation571 reports
- Constellation, Ultravit, 25+, TotalPlus, EdgePlus 8065751617Alcon Laboratories, Inc. · Unit, phacofragmentation2 recalls398 reports
- 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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