VERITAS VISION SYSTEM VRT680300Recalls & reported problems

Summary

The FDA's MAUDE database contains 102 adverse event reports that list this exact device (DI 05050474700864), received between Sep 28, 2021 and Sep 11, 2026 — classified as 75 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Pressure Problem” (20 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 102 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  The customer reported a possible incision burn caused by the Phaco. The physician expressed surprise and noted that he had not encountered this issue since his school years. No patient impact or additional device details were provided.Additional information was received, stating that the surgery date was that the medical doctor did not notice anything different during his Phaco but noticed a "burn" at the main incision. It was also reported that unplanned medical or surgical intervention occurred, with 2x sutures needed, and the sutures were required for a leaky incision due to burn.NOTE: This is report 3 of 4.

  Patient problems: Eye Burn

  MAUDE report 50735060 ↗
• MalfunctionJul 30, 2026Failure to Prime; Suction Problem; Pressure Problem; Noise, Audible

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50091987 ↗
• InjuryJul 13, 2026Suction Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE WITH THE VERITAS CONSOLE, THE LAST QUADRANT DID NOT COME TO THE TIP DURING ASPIRATION. THE SURGEON FLUSHED THE HANDPIECE AND TUBING, BUT ASPIRATION STILL FAILED TO REACH THE TIP. A POSTERIOR CAPSULAR RUPTURE OCCURRED, NECESSITATING AN ANTERIOR VITRECTOMY AND INSERTION OF AN AR40E INTRAOCULAR LENS. ADDITIONAL INFORMATION INDICATED THAT THAT VACUUM INCREASED WITHOUT CORRESPONDING ASPIRATION, SUGGESTING A BLOCKAGE IN THE HANDPIECE OR TUBING PACK. NO FURTHER INFORMATION WAS PROVIDED. NOTE: THIS REPORT IS AGAINST THE VERITAS CONSOLE. A SEPARATE REPORT WILL BE SUBMITTED AGAINST THE HANDPIECE AND TUBING.

  Patient problems: Capsular Bag Tear

  MAUDE report 25807583 ↗
• MalfunctionApr 22, 2026Pressure Problem

  IT WAS REPORTED THAT LOW PRESSURE ERROR 160 GAS FORCED INFUSION (GFI) WAS OBSERVED. PATIENT INVOLVEMENT WAS REPORTED. THROUGH FOLLOW-UP WE LEARNED THAT THE ISSUE OCCURRED DURING THE PROCEDURE. PATIENT IS FINE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24954741 ↗
• MalfunctionApr 21, 2026Pressure Problem

  IT WAS REPORTED THAT THE ERROR E160 INDICATED EXCESSIVELY LOW GAS FORCED INFUSION (GFI) PRESSURE OCCURRED DURING THE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24945585 ↗
• MalfunctionApr 21, 2026Pressure Problem

  IT WAS REPORTED THAT THE ERROR E160 INDICATED EXCESSIVELY LOW GAS FORCED INFUSION PRESSURE OCCURRED DURING THE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24945535 ↗
• MalfunctionApr 2, 2026Pressure Problem

  IT WAS REPORTED THAT THE ERROR 162 GFI (GAS-FORCED INFUSION) OCCURRED DURING THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED DESPITE OF THE ERROR. THERE WAS NO PATIENT INJURY AND NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24766566 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER IMPLANTING IOL (B)(6) AND DURING I&A(VISCOELASTIC REMOVAL), THE OPTIC WAS NOT CENTERED TO THE CAPSULE BAG AND VITREOUS PROLAPSE OCCURRED. ANTERIOR VITRECTOMY PERFORMED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Vitreous Loss

  MAUDE report 24716162 ↗
• MalfunctionMar 4, 2026Computer Software Problem; Pressure Problem

  IT WAS REPORTED THAT ERRORS 160 GAS FORCED INFUSION (DGI) AND ERROR 131 FLUIDIC OCCURRED WITH PATIENT INVOLVEMENT. THROUGH FOLLOW-UP WE LEARNED THAT THE PROBLEM OCCURRED DURING THE PHACOEMULSIFICATION PROCEDURE, THE PROCEDURE WAS COMPLETED IN THE SAME VISIT. NO ISSUES WITH THE PATIENT, NO MEDICAL OR SURGICAL INTERVENTIONS WERE PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24507827 ↗
• InjuryJan 20, 2026Use of Device Problem; Suction Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, A VACUUM ERROR OCCURRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE ACCOUNT ALSO REPORTED THAT THE PHACOEMULSIFICATION PACK WAS RE-USED. CORNEAL BURNS WERE NOTED AROUND THE WOUND. SINCE THE WOUND WOULD NOT CLOSE, IT WAS SUTURED AND THE OPERATION WAS COMPLETED. NO FURTHER INFORMATION WAS PROVIDED. A SEPARATE REPORT WILL BE SUBMITTED FOR THE OTHER INVOLVED PRODUCT.

  Patient problems: Eye Burn

  MAUDE report 24118012 ↗
• MalfunctionJan 15, 2026Pressure Problem

  CUSTOMER REPORTED A GAS FORCED INFUSION (GFI) ERROR 162 AND 161 THAT OCCURRED DURING THE PROCEDURE. THE TECHNICIAN WAS ABLE TO CLEAR THE ERRORS AND SURGEON WAS ABLE TO COMPLETE THE PROCEDURE SAFELY. THERE WAS NO PATIENT INJURY AND NO INTERVENTION REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24082747 ↗
• InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WHO HAD CATARACT SURGERY WITH VERITAS HAD A CORNEAL BURN. NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS AGAINST THE VERITAS. A SEPARATE REPORT WILL BE FILED AGAINST THE HANDPIECE, TIP AND TUBING.

  Patient problems: Eye Burn

  MAUDE report 23812647 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN OPERATING ROOM PROCEDURE INVOLVING PHACOEMULSIFICATION WITH THE VRT AI TUBING, A RUPTURE OF THE CAPSULE OCCURRED. AS A RESULT, A VITRECTOMY WILL BE PERFORMED ON THE PATIENT, AND AN ENCLAVATION LENS WILL BE IMPLANTED. THE PATIENT¿S CURRENT STATUS AND DETAILS REGARDING RECOVERY OR FURTHER MEDICAL ATTENTION REMAIN UNKNOWN. NO ADDITIONAL INFORMATION WAS RECEIVED. THIS REPORT IS FOR THE VERITA VISION SYSTEM. DIFFERENT REPORTS ARE BEING SUBMITTED FOR THE OTHER SUSPECT PRODUCTS.

  Patient problems: Capsular Bag Tear

  MAUDE report 23649843 ↗
• InjuryOct 31, 2025Suction Problem; Suction Problem

  IT WAS REPORTED THAT CORNEAL EDEMA WAS OBSERVED IN PATIENTS AFTER SURGERY INVOLVING THE VERITAS DEVICE. ADDITIONAL DETAILS PROVIDED INDICATE THAT THE CLIENT REPORTED MULTIPLE INSTANCES OF CORNEAL INFLAMMATION AND CHALLENGES WITH ASPIRATION DURING THE PROCEDURE. IT WAS ALSO NOTED THAT THE CUMULATIVE DISSIPATED ENERGY (CDE) PARAMETER DID NOT EXCEED 3%, WHICH WAS CONSIDERED UNUSUAL IN COMPARISON TO OTHER EQUIPMENT. NO FURTHER INFORMATION WAS PROVIDED. NOTE: SEPARATE REPORTS WILL BE FILED FOR THE PHACO TIP, PHACO HANDPIECE AND TUBING PACK.

  Patient problems: Conjunctivitis; Corneal Edema

  MAUDE report 23440151 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING CATARACT SURGERY USING VERITAS MACHINE, THE DOCTOR RUPTURED PATIENT'S POSTERIOR CHAMBER BAG. THE ORIGINAL INTRAOCULAR LENS (IOL) TO BE IMPLANTED WAS CHANGED TO A THREE-PIECE LENS WHICH WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY AND WITHOUT INJURY OR COMPLICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS AGAINST THE VERITAS CONSOLE. A SEPARATE REPORT WILL BE FILED AGAINST THE TIP AND HANDPIECE.

  Patient problems: Capsular Bag Tear

  MAUDE report 23439453 ↗
• InjuryOct 31, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT DURING PROCEDURE THE VITRECTOMY CUTTER DEVICE DIDN'T MOVE. PRIME AND TUNE HAD SUCCESSFULLY PASSED AND THE CUT RATE WAS CONFIRMED IN THREE STAGES 50, 500 AND 2500. THE ACCOUNT INDICATED THAT THE PATIENT'S VITREOUS BODY WAS REMOVED USING A DIFFERENT METHOD AND THE OPERATION WAS SUCCESSFULLY COMPLETED. THROUGH FOLLOW-UP, WE LEARNED, THAT THE PATIENT'S CAPSULE WAS DAMAGED DURING PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS AGAINST THE VERITAS CONSOLE. A SEPARATE REPORT WILL BE SUBMITTED AGAINST THE VITRECTOMY CUTTER.

  Patient problems: Capsular Bag Tear

  MAUDE report 23438299 ↗
• MalfunctionOct 24, 2025Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT THE FOLLOWING ERRORS WERE DISPLAYED DURING PROCEDURE: 161-GFI PRESSURE HIGH AND162-GFI NOT AVAILABLE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23380695 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED WOUND BURNS AND CORNEAL EDEMA AFFECTING MULTIPLE PATIENTS WHILE USING THE VERITAS SYSTEM. NO FURTHER INFORMATION WAS PROVIDED. NOTE: THIS IS REPORT 1 OF 4..

  Patient problems: Corneal Edema; Eye Burn

  MAUDE report 23372387 ↗
• MalfunctionSep 17, 2025Computer Software Problem; Mechanical Problem; Computer Software Problem; Mechanical Problem

  IT WAS REPORTED THAT SYSTEM HAD 131 FLUIDICS MODE ERROR AND SYSTEM BLOCKED. IT IS UNKNOWN IF THE ERROR OCCURRED DURING THE CATARACT PROCEDURE OR PRIOR TO IT (DURING PRIMING AND TUNING).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23080680 ↗
• InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A PHACO BURN ON RIGHT EYE WHICH OCCURRED ALMOST IMMEDIATELY AFTER DOCTOR BEGAN PHACO ON A MILDLY DENSE CATARACT. POST-OP NOTES FROM SAME DAY OF SURGERY: ANTERIOR CHAMBER IS DEEP WITH MILD DEBRIS. POSTERIOR CAPSULE INTRAOCULAR LENS (PCIOL) IS IN THE BAG AND CENTERED INTRAOCULAR PRESSURE IS PHYSIOLOGIC. POST-OP MEDS REVIEWED. FULL TIME EYE SHIELD UNTIL TOMORROW AM, THEN AT BEDTIME. POST-OP DAY 1 CATARACT EXTRACTION RIGHT EYE: LATERAL STITCHES X 2 (WITH PLAN TO REMOVE IN A FEW WEEKS). 20/100 VISUAL ACUITY. STANDARD MEDICATION. NOTE: THIS REPORT IS 1 OF 5.

  Patient problems: Eye Burn

  MAUDE report 22872142 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A PHACO BURN. NO ADDITIONAL INFORMATION WAS PROVIDED. NOTE: THIS REPORT IS 1 OF 5.

  Patient problems: Eye Burn

  MAUDE report 22868728 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A PHACO BURN. NO ADDITIONAL INFORMATION WAS PROVIDED. NOTE: THIS REPORT IS 1 OF 5.

  Patient problems: Eye Burn

  MAUDE report 22868439 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A PHACO BURN. NO ADDITIONAL INFORMATION WAS PROVIDED. NOTE: THIS REPORT IS 1 OF 5.

  Patient problems: Eye Burn

  MAUDE report 22867656 ↗
• InjuryJul 23, 2025Infusion or Flow Problem; Infusion or Flow Problem

  THE CUSTOMER REPORTED A CORNEAL BURN THAT NECESSITATED THREE SUTURES, ATTRIBUTING THE INJURY TO AN ISSUE WITH THE FLOW OF IRRIGATION DURING THE USE OF THE HANDPIECE. THE CUSTOMER ALSO INDICATED THAT NO ADDITIONAL PATIENT INTERVENTION OR INJURY WAS ASSOCIATED WITH THE INCIDENT. THIS REPORT IS FOR THE VERITAS PHACO SYSTEM. SEPARATE REPORTS WILL BE SUBMITTED FOR OTHER PRODUCTS USED DURING THE EVENT.

  Patient problems: Eye Burn

  MAUDE report 22578647 ↗
• InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER THAT DURING A PHACO PROCEDURE, A PATIENT EXPERIENCED A CHOROIDAL HEMORRHAGE ON THE RIGHT EYE (OCULUS DEXTER) OD. DURING THE LAST PATIENT OF THE DAY, WHICH WAS THE 9TH CASE. THE PROCEDURE WAS ROUTINE AND PROGRESSING WELL UNTIL THE PHYSICIAN OBSERVED A VERY SHALLOW ANTERIOR CHAMBER AND A FIRM GLOBE WHILE ATTEMPTING TO REMOVE THE CORTEX. PHYSICIAN SUBSEQUENTLY CALLED FOR THE ON-CALL RETINA SURGEON, WHO PERFORMED A POSTERIOR SURGERY TO ADDRESS THE ISSUE. THE CAUSE OF THE CHOROIDAL HEMORRHAGE REMAINS UNKNOWN, AND THERE WERE NO ISSUES REPORTED WITH THE FIRST EIGHT CASES.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Choroidal effusion

  MAUDE report 22503576 ↗