SIL. COATED I/A 45 MIL 12/B 85910SRecalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04058935000349), received between Mar 26, 2024 and Apr 16, 2024 — classified as 3 injuries.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (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
- Physical Resistance/Sticking3
- Material Too Soft/Flexible1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Capsular Bag Tear1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryApr 16, 2024Material Too Soft/Flexible; Physical Resistance/Sticking; Material Too Soft/Flexible; Physical Resistance/Sticking
IT WAS REPORTED BY THE USER FACILITY IN AUSTRALIA THAT THE SILICONE TIP NORMALLY HAS ENOUGH MOVEMENT THAT YOU CAN PIVOT THE TIP NASALLY AND TEMPORALLY TO REMOVE CORTEX. RECENTLY THE SILICONE SLEEVE WAS SO SOFT IT TWISTED AROUND THE METAL TIP OCCLUDING FLOW AND WOULD NOT UNTWIST SPONTANEOUSLY UNLESS THE TIP WAS REMOVED FROM EYE. IN ONE OF MY CASES THE SLEEVE TWISTED SUCH AS THAT THE METAL TIP OF IA WAS EXPOSED RESULTING IN MY FIRST PC RUPTURE FOR MANY YEARS. ADDITIONALLY REPORTED CAUSE WAS DUE TO ISSUES OF CAPSULE TEARS AND FLOPPY SILICON TIPS.
Patient problems: Capsular Bag Tear
MAUDE report 19119069 ↗InjuryMar 26, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
SUTURES ARE NOT REQUIRED AS PART OF THE NORMAL CATARACT PROCEDURE. THE WERE REQUIRED DUE TO TWISTING ISSUES OF THE I/A HP HAVING AN EFFECT ON THE WOUND STRUCTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18977527 ↗InjuryMar 26, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
SUTURES ARE NOT REQUIRED AS PART OF THE NORMAL CATARACT PROCEDURE. THE WERE REQUIRED DUE TO TWISTING ISSUES OF THE I/A HP HAVING AN EFFECT ON THE WOUND STRUCTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18977512 ↗
Other Unit, Phacofragmentation devices
- Centurion 8065751763Alcon Laboratories, Inc. · Unit, phacofragmentation728 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page