StellarisRecalls & reported problems across all models
Bausch & Lomb Incorporated · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 24
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls
- 0
We found 5 models of Stellaris by Bausch & Lomb Incorporated in the FDA's device registry (GUDID). Together they are named in 24 adverse event reports in the FDA's MAUDE database, received between Jul 19, 2021 and Apr 14, 2026 — classified as 16 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Unexpected Shutdown” (6 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Stellaris problems
Device problems
- Unexpected Shutdown6
- Adverse Event Without Identified Device or Use Problem4
- Infusion or Flow Problem3
- Circuit Failure1
- Communication or Transmission Problem1
- Decrease in Suction1
- Failure to Deliver Energy1
- Intermittent Communication Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- Capsular Bag Tear5
- Insufficient Information3
- Eye Injury2
- Corneal Edema1
- Eye Burn1
- Inflammation1
- Intraocular Infection1
Stellaris models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Stellaris BL11110Instrument, Vitreous Aspiration And Cutting, Ac-Powered8 reports
- Stellaris BL1433Instrument, Vitreous Aspiration And Cutting, Ac-Powered6 reports
- Stellaris BL11114Instrument, Vitreous Aspiration And Cutting, Ac-Powered4 reports
- Stellaris BL14304Instrument, Vitreous Aspiration And Cutting, Ac-Powered4 reports
- Stellaris BL14334Instrument, Vitreous Aspiration And Cutting, Ac-Powered2 reports
Recent Stellaris adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 14, 2026Power Problem
THE USER FACILITY IN RUSSIA REPORTS EXPERIENCING AN UNEXPECTED POWER INTERRUPTION TWO TO FOUR TIMES A DAY. IT WAS REPORTED THERE WAS NO MEDICAL INTERVENTION/TREATMENT REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24873465 ↗InjuryFeb 5, 2026Infusion or Flow Problem
THE USER FACILITY IN FRANCE REPORTED THAT DURING A VITRECTOMY, THE IRRIGATION WAS TOO LOW TO CONTINUE. IT WAS VERY LOW EVEN WHEN THEY SET THE IV POLE HIGHER. THE SURGEON FELT UNCOMFORTABLE AND DID NOT PROPERLY END THE VITRECTOMY SURGERY. THE PROCEDURE WAS ABORTED.
Patient problems: Insufficient Information
MAUDE report 24270146 ↗InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A USER FACILITY IN JAPAN REPORTED THAT DURING CATARACT SURGERY THE IRRIGATION PRESSURE WAS TOO HIGH AND AFTER INSERTING THE HANDPIECE THE CAPSULE RUPTURED. THE SYSTEM WAS SWITCHED OUT TO A DIFFERENT MANUFACTURER AND A VITRECTOMY WAS COMPLETED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.
Patient problems: Capsular Bag Tear
MAUDE report 23881352 ↗InjuryNov 18, 2025Suction Problem; Suction Problem
IT WAS REPORTED THAT THE VETERINARY SYSTEM STOPPED SUCTIONING DURING THE CASE AND WOULD NOT ASPIRATE ANY LONGER. THERE WAS NO BACKUP SYSTEM ON SITE. INITIALLY, ENOUGH GENERAL ANESTHESIA WAS ADMINISTERED TO BE ABLE TO COMPLETE BOTH EYES. THE LEFT EYE WAS COMPLETED, BUT THE DOCTOR BELIEVES A RADIAL TEAR OCCURRED DUE TO THE HANDPIECE NOT ASPIRATING CORRECTLY. FOR THE RIGHT EYE, THE CANINE PATIENT HAD TO BE WOKEN, AND DUE TO THEIR DIABETES WAIT FOR ABOUT 6 HOURS TO TRANSFER TO ANOTHER FACILITY. THE PATIENT WAS PUT BACK UNDER GENERAL ANESTHESIA AT THE OTHER FACILITY AND THE RIGHT EYE WAS COMPLETED. LENSES WERE INSERTED IN BOTH EYES.
Patient problems: Eye Injury
MAUDE report 23584008 ↗MalfunctionNov 6, 2025Unexpected Shutdown; Unexpected Shutdown
THE USER FACILITY IN UNITED KINGDOM REPORTED THE SYSTEM SHUT DOWN DURING A PROCEDURE. THE SYSTEM WAS REBOOTED AND THE PROCEDURE RESUMED WITH NO FURTHER ISSUES. THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23487118 ↗InjurySep 12, 2025Infusion or Flow Problem; Infusion or Flow Problem
THE USER FACILITY REPORTED FLUID STOP FLOWING DURING VITRECTOMY. THEY CHANGED DISPOSABLE PRODUCTS AND THE HANDPIECE AND CONFIRMED IT IS NOT A HANDPIECE ISSUE. ONCE THEY SWITCHED OUT THE PRODUCTS THEY CLOSED OUT OF THE CURRENT PROCEDURE ON THE SCREEN AND START A NEW ONE. IT TOOK ABOUT 10 MINUTES OF TROUBLESHOOTING. THE PATIENT WAS UNDER GENERAL ANESTHESIA AND DID NOT RECEIVE ADDITIONAL ANESTHESIA TIME. BY THE TIME THE INFUSION LINE WAS REESTABLISHED, THERE WAS BLEEDING AND THE PROCEDURE NEEDED TO BE STOPPED. AFTER FOLLOWING UP WITH THE SURGEON, IT DID NOT SOUND LIKE THERE WAS ADDITIONAL DAMAGE TO THE PATIENT'S EYE, JUST THAT WE WERE NOT ABLE TO COMPLETE THE SURGERY. CURRENTLY THIS PATIENT IS NOT BOOKED FOR ANOTHER CASE.
Patient problems: Insufficient Information
MAUDE report 23037142 ↗InjuryJul 25, 2025Infusion or Flow Problem; Infusion or Flow Problem
THE CHINA NATIONAL DEVICE ADVERSE EVENT REPORTING SYSTEM SUBMITTED THIS REPORT WHERE THERE WAS A POSTERIOR CAPSULE RUPTURE DURING CATARACT SURGERY. THERE WAS A SUDDEN LOSS OF INFUSION DURING SURGERY (INFUSION FLUID IS PRESENT) CAUSING THE PATIENT'S ANTERIOR CHAMBER TO COLLAPSE AND THE POSTERIOR CAPSULE TO RUPTURE. THE VITREOUS WAS PARTIALLY REMOVED AND AN INTRAOCULAR LENS WAS IMPLANTED IN THE CILIARY SULCUS. THE PATIENT'S CONDITION WAS TEMPORARILY STABILIZED.
Patient problems: Capsular Bag Tear
MAUDE report 22609246 ↗MalfunctionJun 19, 2025Unexpected Shutdown; Unexpected Shutdown
IT WAS REPORTED BY THE USER FACILITY IN MALAYSIA THAT THE SYSTEM WAS SHOWING VFM14 DURING THE PROCEDURE HOWEVER FLUID LEVEL IN CASSETTE WAS NOT FULL. WRONGLY DETECTED FLUIDIC LEVEL EVEN AFTER A NEW CASSETTE WAS INSERTED. THE FIELD SERVICE ENGINEER REPORTED THAT THE SYSTEM STOPPED UNINTENTIONALLY AFTER THE ERROR. THERE WAS A MINIMAL DELAY TO RESTART AND REINSERT THE CASSETTE. NO MEDICAL INTERVENTION OR TREATMENT WAS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22292074 ↗MalfunctionJun 6, 2025Unexpected Shutdown; Unexpected Shutdown
THE USER FACILITY REPORTED THE SYSTEM SHUTDOWN DURING SURGERY 2 TIMES IN LAST 2 MONTHS. THEY REBOOTED THE SYSTEM AND THEN IT WAS OK. FOOT CONTROL WAS PLUGGED IN DURING THE SHUTDOWNS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22157474 ↗InjuryMay 6, 2025Unintended Ejection; Unintended Ejection
A USER FACILITY IN JAPAN REPORTED THAT DURING A PROCEDURE, WHEN STARTING ASPIRATION, THE CASSETTE WAS EJECTED. ADDITIONAL INFORMATION RECEIVED (B)(6) 2025 FROM AFFILIATE STATES THAT DURING THE SURGERY, DESPITE REPLACING THE UNIT WITH A NEW PACK, THE ISSUE WAS NOT RESOLVED. THE SURGERY WAS SUSPENDED ABOUT 2 HOURS AND 30 MINUTES. FOLLOWING AN ON-SITE INSPECTION BY THE TECHNICIAN, THE PROCEDURE WAS RESUMED AND COMPLETED WITHOUT FURTHER COMPLICATIONS. (DETAILS REGARDING THE USE OF ADDITIONAL ANESTHESIA REMAIN UNKNOWN.) WHILE A MALFUNCTION WAS INITIALLY SUSPECTED, A SUBSEQUENT INSPECTION CONDUCTED ON THE FOLLOWING MORNING DID NOT REVEAL ANY ABNORMALITIES WITH THE SYSTEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21970096 ↗InjuryApr 2, 2025No Audible Alarm; No Audible Alarm
THE USER FACILITY IN FRANCE REPORTED THAT DURING THE FRAGMENTATION PHASE, WITHOUT AUDIBLE ALERT, THE PHACOEMULSIFIER SWITCHED TO MAX SUCTION MODE WITH RUPTURE. THE SUCTION TRIGGERED ON ITS OWN WHEN THE SURGEON HAD OPERATED AT THE BOTTOM OF THE GROOVE, AND WITHOUT WARNING. THE PATIENT EXPERIENCED EDEMA/INFLAMMATION AND A VITRECTOMY WAS IMPOSSIBLE DUE TO LOCAL ANESTHESIA. THE PATIENT'S BEST CORRECTED VISUAL ACUITY IS 1/20.
Patient problems: Capsular Bag Tear; Corneal Edema; Intraocular Infection
MAUDE report 21752066 ↗InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A USER FACILITY IN AUSTRALIA REPORTED 2 CASES WHERE THE ANTERIOR CHAMBER COMPLETELY COLLAPSED DURING SEGMENT STAGE WITH THE PHACO TIP COMPLETELY IN THE EYE. BOTH TIMES THE CAPSULAR BAG WAS TORN AND RESULTED IN VITRECTOMIES. THE CASES ENDED UP HAVING TO BE ABANDONED AND WILL NEED A VR SURGEON TO REVISIT FOR A POSTERIOR VITRECTOMY AND SULCUS LENS. THIS REPORT IS FOR THE 1ST PATIENT.
Patient problems: Capsular Bag Tear
MAUDE report 21636175 ↗InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A USER FACILITY IN AUSTRALIA REPORTED 2 CASES WHERE THE ANTERIOR CHAMBER COMPLETELY COLLAPSED DURING SEGMENT STAGE WITH THE PHACO TIP COMPLETELY IN THE EYE. BOTH TIMES THE CAPSULAR BAG WAS TORN AND RESULTED IN VITRECTOMIES. THE CASES ENDED UP HAVING TO BE ABANDONED AND WILL NEED A VR SURGEON TO REVISIT FOR A POSTERIOR VITRECTOMY AND SULCUS LENS. THIS REPORT IS FOR THE 2ND PATIENT.
Patient problems: Capsular Bag Tear
MAUDE report 21636062 ↗InjuryFeb 5, 2025Failure to Deliver Energy; Failure to Deliver Energy
SURGEON CONFIRMED THAT THE PATIENT WAS OKAY AFTER THE OPERATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21315112 ↗MalfunctionDec 9, 2024Unintended Application Program Shut Down; Unintended Application Program Shut Down
IT WAS REPORTED THAT THE SYSTEM LOST POWER DURING A PROCEDURE. THEY WIGGLED THE POWER CORD, AND IT CAME BACK ON. THE SITE THEN TAPED THE CORD TO THE MACHINE AND LOST POWER AGAIN. THEY USED A BACKUP SYSTEM TO CONTINUE. NO PATIENT IMPACT OR MEDICAL INTERVENTION REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20880098 ↗
Other Bausch & Lomb Incorporated products
- enVista IOL74 models · 70 reports · 1 recall
- enVista Toric IOL450 models · 15 reports · 2 recalls
- enVista Envy IOL53 models · 52 reports · 1 recall
- enVista Envy Toric IOL513 models · 39 reports · 1 recall
- Akreos IOL8 models · 10 reports · 1 recall
- enVista Aspire IOL57 models · 10 reports · 1 recall
- enVista Aspire Toric IOL513 models · 8 reports · 1 recall
- IC-8 Apthera IOL20 models · 38 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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