VERITAS SWIVEL PHACO HANDPIECE SYSTEM VRT691027Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 05050474700888), received between Jun 4, 2021 and Dec 21, 2023 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (16 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.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 21, 2023Overheating of Device; Noise, Audible; Overheating of Device; Noise, Audible

  IT WAS REPORTED THAT THEIR HANDPIECE WAS HOT IN THE PHYSICIAN'S HAND AND PHACO SOUNDED FUNNY. INITIAL TUNE AND PRIME WERE FINE. NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18378794 ↗
• MalfunctionMar 8, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE SURGEON EXPERIENCED SOME DIFFICULTY WITH THE VERITAS SWIVEL HANDPIECE. THE SURGEON EXPERIENCED THREE CLOGS, ALL LESS THAN 5 SECONDS. ALL CLEARED SPONTANEOUSLY. THERE WAS NO PATIENT IMPACT FROM THE CLOGGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13700745 ↗
• MalfunctionJan 26, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT HANDPIECE EXPERIENCE OCCLUSION. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13353448 ↗
• MalfunctionJul 28, 2021Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT HANDPIECE GOT CLOGGED DURING SURGERY. CASE WAS FINISHED FINE WITH ELLIPS FX HANDPIECE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12236656 ↗
• MalfunctionJul 28, 2021Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT HANDPIECE GOT CLOGGED DURING SURGERY. CASE WAS FINISHED FINE WITH ELLIPS FX HANDPIECE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12236641 ↗
• MalfunctionJul 28, 2021Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT HANDPIECE GOT CLOGGED DURING SURGERY. CASE WAS FINISHED WITH ELLIPS FX HAND PIECE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12236632 ↗
• MalfunctionJul 28, 2021Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT HANDPIECE GOT CLOGGED DURING SURGERY. CASES WERE FINISHED WITH ELLIPS FX HAND PIECE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12236506 ↗
• MalfunctionJun 10, 2021Complete Blockage; Complete Blockage

  DURING A CATARACT PROCEDURE, THE PHACO VERITAS SWIVEL HANDPIECE BECAME CLOGGED DURING SURGERY. A DESCRIPTION FROM THE SURGERY CENTER INDICATED THERE WAS CLOGGING IN THE HANDPIECE USING THE SETTINGS FOR VENTURI VACUUM AT 375MMHG AND A 19-GAUGE TIP. THE CLOG WAS CLEARED BY REMOVING HANDPIECE OUT OF EYE AND IMMERSING TIP IN BALANCE SALT SOLUTION (BSS), BUILDING TO MAX VACUUM AND PHACO POWER, PINCHING ASPIRATION LINE AND THEN RELEASING. THE PROCEDURE WAS COMPLETED, AND NO PATIENT INJURY REPORTED. IT WAS REPORTED THE HANDPIECE WILL NOT RETURN FOR EVALUATION AND THE TUBING PACK WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11975059 ↗
• MalfunctionJun 8, 2021Complete Blockage; Complete Blockage

  DURING A CATARACT PROCEDURE, THE PHACO VERITAS SWIVEL HANDPIECE WAS CLOGGED. A DESCRIPTION FROM THE SURGERY CENTER INDICATED DURING THE QUADRANT REMOVAL OF A DENSE NUCLEUS, THERE WAS CLOGGING AND POOR VACUUM USING THE PERISTALTIC PUMP AND 20 GAUGE REUSABLE STRAIGHT TIP. THE SURGEON PULLED THE HANDPIECE OUT OF PATIENT'S EYE AND TRIED DIFFERENT THINGS IN BALANCE SALT SOLUTION (BSS). THE SYSTEM REACHED MAXIMUM VACUUM IN BSS AND IT WASN'T POSSIBLE TO HAVE REFLUX. THE TIP WAS REPLACED, AND IT WAS THE SAME ISSUE. THE CLOGGING WAS RESOLVED WHEN THE SURGEON SWITCHED TO AN ELLIPS FX HANDPIECE AND IT WORKED AS USUAL. THE PROCEDURE WAS COMPLETED, AND NO PATIENT INJURY REPORTED. IT WAS REPORTED THE HANDPIECE WILL NOT RETURN FOR EVALUATION AS THE HANDPIECE WAS SENT FOR CLEANING AND STERILIZATION AFTER THE EVENT AND USED THE FOLLOWING DAY AND IS FUNCTIONING NORMALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11957966 ↗
• MalfunctionJun 4, 2021Complete Blockage; Suction Problem; Complete Blockage; Suction Problem

  DURING A CATARACT PROCEDURE, THE PHACO TIP WAS CLOGGED WHICH CAUSED 501 VACUUM ERRORS TO OCCUR. A DESCRIPTION FROM THE SURGERY CENTER INDICATED DURING THE PHACO PROCEDURE, A 501 VACUUM ERROR DISPLAYED AND FREQUENT CLOGS. THE PROCEDURE WAS COMPLETED, AND NO PATIENT INJURY REPORTED. THROUGH FOLLOW UP, THE SURGERY CENTER HAS 8 PHACO HANDPIECES THAT WERE IN USE AT THE TIME OF THE EVENT. THE CLOGGING OCCURRED DURING THE PROCEDURE 3 OR 4 DIFFERENT TIMES/EVENTS, HOWEVER UNABLE TO DETERMINE WHICH SPECIFIC HANDPIECE HAD THE CLOG DURING SURGERY. AS A PROACTIVE MEASURE, ALL HANDPIECES WILL BE REPORTED AND RETURNED FOR EVALUATION. THIS IS 6 OF 8 REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11942305 ↗
• MalfunctionJun 4, 2021Complete Blockage; Suction Problem; Complete Blockage; Suction Problem

  DURING A CATARACT PROCEDURE, THE PHACO TIP WAS CLOGGED. A DESCRIPTION FROM THE SURGERY CENTER INDICATED DURING THE PHACO PROCEDURE, THERE WAS POOR VACUUM AND POTENTIAL FREQUENT CLOGS. THE PROCEDURE WAS COMPLETED, AND NO PATIENT INJURY REPORTED. THROUGH FOLLOW UP, THE SURGERY CENTER HAS 8 PHACO HANDPIECES THAT WERE IN USE AT THE TIME OF THE EVENT. THE CLOGGING OCCURRED DURING THE PROCEDURE 3 OR 4 DIFFERENT TIMES/EVENTS, HOWEVER UNABLE TO DETERMINE WHICH SPECIFIC HANDPIECE HAD THE CLOG DURING SURGERY. AS A PROACTIVE MEASURE, ALL HANDPIECES WILL BE REPORTED AND RETURNED FOR EVALUATION. THIS IS 3 OF 8 REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11942292 ↗
• MalfunctionJun 4, 2021Complete Blockage; Suction Problem; Complete Blockage; Suction Problem

  DURING A CATARACT PROCEDURE, THE PHACO TIP WAS CLOGGED. A DESCRIPTION FROM THE SURGERY CENTER INDICATED DURING THE PHACO PROCEDURE, THERE WAS POOR VACUUM AND POTENTIAL FREQUENT CLOGS. THE PROCEDURE WAS COMPLETED, AND NO PATIENT INJURY REPORTED. THROUGH FOLLOW UP, THE SURGERY CENTER HAS 8 PHACO HANDPIECES THAT WERE IN USE AT THE TIME OF THE EVENT. THE CLOGGING OCCURRED DURING THE PROCEDURE 3 OR 4 DIFFERENT TIMES/EVENTS, HOWEVER UNABLE TO DETERMINE WHICH SPECIFIC HANDPIECE HAD THE CLOG DURING SURGERY. AS A PROACTIVE MEASURE, ALL HANDPIECES WILL BE REPORTED AND RETURNED FOR EVALUATION. THIS IS 5 OF 8 REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11941902 ↗
• MalfunctionJun 4, 2021Complete Blockage; Suction Problem; Complete Blockage; Suction Problem

  DURING A CATARACT PROCEDURE, THE PHACO TIP WAS CLOGGED. A DESCRIPTION FROM THE SURGERY CENTER INDICATED DURING THE PHACO PROCEDURE, THERE WAS POOR VACUUM AND POTENTIAL FREQUENT CLOGS. THE PROCEDURE WAS COMPLETED, AND NO PATIENT INJURY REPORTED. THROUGH FOLLOW UP, THE SURGERY CENTER HAS 8 PHACO HANDPIECES THAT WERE IN USE AT THE TIME OF THE EVENT. THE CLOGGING OCCURRED DURING THE PROCEDURE 3 OR 4 DIFFERENT TIMES/EVENTS, HOWEVER UNABLE TO DETERMINE WHICH SPECIFIC HANDPIECE HAD THE CLOG DURING SURGERY. AS A PROACTIVE MEASURE, ALL HANDPIECES WILL BE REPORTED AND RETURNED FOR EVALUATION. THIS IS 2 OF 8 REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11941385 ↗
• MalfunctionJun 4, 2021Complete Blockage; Failure to Prime; Suction Problem; Complete Blockage; Failure to Prime; Suction Problem

  DURING A CATARACT PROCEDURE, THE PHACO TIP WAS CLOGGED. A DESCRIPTION FROM THE SURGERY CENTER INDICATED DURING THE PHACO PROCEDURE, A 501 AND 601 VACUUM ERROR DISPLAYED AND FREQUENT CLOGS. THE PROCEDURE WAS COMPLETED, AND NO PATIENT INJURY REPORTED. THROUGH FOLLOW UP, THE SURGERY CENTER HAS 8 PHACO HANDPIECES THAT WERE IN USE AT THE TIME OF THE EVENT. THE CLOGGING OCCURRED DURING THE PROCEDURE 3 OR 4 DIFFERENT TIMES/EVENTS, HOWEVER UNABLE TO DETERMINE WHICH SPECIFIC HANDPIECE HAD THE CLOG DURING SURGERY. AS A PROACTIVE MEASURE, ALL HANDPIECES WILL BE REPORTED AND RETURNED FOR EVALUATION. THIS IS 4 OF 8 REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11941123 ↗
• MalfunctionJun 4, 2021Complete Blockage; Failure to Prime; Suction Problem; Complete Blockage; Failure to Prime; Suction Problem

  DURING A CATARACT PROCEDURE, THE PHACO TIP WAS CLOGGED. A DESCRIPTION FROM THE SURGERY CENTER INDICATED DURING THE PHACO PROCEDURE, A 501 AND 601 VACUUM ERROR DISPLAYED AND FREQUENT CLOGS. THE PROCEDURE WAS COMPLETED, AND NO PATIENT INJURY REPORTED. THROUGH FOLLOW UP, THE SURGERY CENTER HAS 8 PHACO HANDPIECES THAT WERE IN USE AT THE TIME OF THE EVENT AND THAT THE CLOGGING DURING THE PROCEDURE ONLY OCCURRED 3 OR 4 TIMES, HOWEVER UNABLE TO DETERMINE WHICH SPECIFIC HANDPIECE HAD THE CLOG DURING SURGERY. AS A PROACTIVE MEASURE, ALL HANDPIECES WILL BE REPORTED AND RETURNED FOR EVALUATION. THIS IS 1 OF 8 REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11941119 ↗
• MalfunctionJun 4, 2021Complete Blockage; Fluid/Blood Leak; Complete Blockage; Fluid/Blood Leak

  DURING A CATARACT PROCEDURE, THE PHACO TIP MAY HAVE BEEN CLOGGED AND LEAKS WERE REPORTED. A DESCRIPTION FROM THE SURGERY CENTER INDICATED DURING THE PHACO PROCEDURE, CLOGGING MAY HAVE OCCURRED. IT WAS ALSO REPORTED THERE WAS BALANCE SALT SOLUTION LEAKING FROM THE PLASTIC HOUSING OF THE HANDPIECE. A BRIEF DESCRIPTION IS WHEN FLUSHING OUT THE HANDPIECE, A POPPING SOUND WAS HEARD FOLLOWED BY FLUID EXCITING VENT HOLES IN THE PLASTIC HOUSING. THE PROCEDURE WAS COMPLETED, AND NO PATIENT INJURY REPORTED. THROUGH FOLLOW UP, THE SURGERY CENTER HAS 8 PHACO HANDPIECES THAT WERE IN USE AT THE TIME OF THE EVENT. THE CLOGGING OCCURRED DURING THE PROCEDURE 3 OR 4 DIFFERENT TIMES/EVENTS, HOWEVER UNABLE TO DETERMINE WHICH SPECIFIC HANDPIECE HAD THE CLOG DURING SURGERY. AS A PROACTIVE MEASURE, ALL HANDPIECES WILL BE REPORTED AND RETURNED FOR EVALUATION. THIS IS 7 OF 8 REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11941069 ↗
• MalfunctionJun 4, 2021Complete Blockage; Suction Problem; Complete Blockage; Suction Problem

  DURING A CATARACT PROCEDURE, THE PHACO TIP WAS CLOGGED. A DESCRIPTION FROM THE SURGERY CENTER INDICATED DURING THE PHACO PROCEDURE, THERE WAS POOR VACUUM AND FREQUENT CLOGS. THE PROCEDURE WAS COMPLETED, AND NO PATIENT INJURY REPORTED. THROUGH FOLLOW UP, THE SURGERY CENTER HAS 8 PHACO HANDPIECES THAT WERE IN USE AT THE TIME OF THE EVENT. THE CLOGGING OCCURRED DURING THE PROCEDURE 3 OR 4 DIFFERENT TIMES/EVENTS, HOWEVER UNABLE TO DETERMINE WHICH SPECIFIC HANDPIECE HAD THE CLOG DURING SURGERY. AS A PROACTIVE MEASURE, ALL HANDPIECES WILL BE REPORTED AND RETURNED FOR EVALUATION. THIS IS 8 OF 8 REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11940826 ↗