WHITESTAR SIGNATURE NGP680300Recalls & reported problems

Summary

The FDA's MAUDE database contains 126 adverse event reports that list this exact device (DI 05050474534476), received between Sep 12, 2016 and Jul 17, 2026 — classified as 90 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (21 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 25 most recent of 126 reports, in the reporter's own words as published by the FDA.

• InjuryJul 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A CORNEAL BURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Burn

  MAUDE report 25856137 ↗
• InjuryMar 17, 2025Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT THIRTY MINUTES AFTER STARTING THE SYSTEM, AN ALARM SOUNDED, INDICATING "360 IH FLUIDICS - READ ERROR. THE PATIENT'S ANTERIOR CHAMBER COLLAPSED AND THE ANTERIOR CAPSULE ROSE AND BROKE. THERE WAS AN ERROR DURING STARTUP. THE ACCOUNT ALSO INDICATED THAT HE HAD RAISED THE BOTTLE BECAUSE THE CAPSULE ROSE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear

  MAUDE report 21619875 ↗
• InjuryDec 6, 2024Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT DURING CONTINUOUS CURVILINEAR CAPSULORHEXIS THE ERROR CODE E148 APPEARED WITH THE FOLLOWING MESSAGE "CUTTING PRESSURE IS BEING APPLIED" AND THE PUMP OPERATION SOUND CONTINUED. AFTER MULTIPLE RESTARTS WERE PERFORMED, THE PUMP SOUND STOPPED ONCE AND THEN ERROR CODE E126 APPEARED. THE SURGERY WAS HALTED MIDWAY, AND THE PATIENT WAS TRANSPORTED TO A HOSPITAL. ON THE SAME DAY, AN EMERGENCY SURGERY WAS PERFORMED AT THE HOSPITAL TO IMPLANT THE INTRAOCULAR LENS WITHOUT ANY PROBLEM. AFTER SURGERY THE PATIENT VISITED THE CLINIC WITHOUT ANY PROBLEMS AND VISUAL ACUITY WAS MAINTAINED AT 1.0.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20873219 ↗
• MalfunctionJul 10, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, IN PHACOEMULSIFICATION MODE, THE FOLLOWING SYSTEM ERROR OCCURRED: ERROR 374 "HANDPIECE REMOVED DURING PHACO". NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19712010 ↗
• MalfunctionJun 28, 2024Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT ERROR 374 OCCURRED DURING THE PROCEDURE AND CAUSED THE HANDPIECE TO BE REMOVED DURING PHACOEMULSIFICATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19633895 ↗
• MalfunctionSep 1, 2023Computer Software Problem; Fire; Unexpected Shutdown; Computer Software Problem; Fire; Unexpected Shutdown

  CUSTOMER REPORTED THAT THEIR WHITESTAR SIGNATURE SYSTEM EMITTED SMOKE AND SHUT DOWN MID CASE. SYSTEM RESTARTED ITSELF AND DISPLAYED ERROR CODES. NO PATIENT INJURY AND PROCEDURE WAS COMPLETED WITH BACKUP SYSTEM. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17671285 ↗
• InjuryAug 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED A CORNEAL BURN ON WHILE USING THEIR WHITESTAR SIGNATURE SYSTEM. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Eye Burn

  MAUDE report 17607945 ↗
• InjuryAug 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED A CORNEAL BURN ON WHILE USING THEIR WHITESTAR SIGNATURE SYSTEM. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Eye Burn

  MAUDE report 17607619 ↗
• InjuryAug 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED A CORNEAL BURN ON WHILE USING THEIR WHITESTAR SIGNATURE SYSTEM. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Eye Burn

  MAUDE report 17607589 ↗
• InjuryDec 15, 2022Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT THERMAL BURN OCCURRED DURING CATARACT SURGERY ON A PATIENTS UNKNOWN EYE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH BACKUP, CORNEAL INCISION 2 4MM. NO SURGICAL INTERVENTION WAS REQUIRED. THERE WAS NO PATIENT INJURY. THE PATIENT WAS PRESCRIBED RINDERON AND DIAMOX. IT WAS STATED THAT THE PATIENT IS RECOVERING POSTOPERATIVELY. INTRAOCULAR PRESSURE HAD TEMPORARILY BEEN SLIGHTLY HIGH, BUT IT IS DECREASING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Burn(s); Intraocular Pressure Increased

  MAUDE report 15988580 ↗
• InjuryMay 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT HAS BEEN REPORTED THAT SOME PATIENTS HAD EDEMA AFTER SURGERY. THROUGH FOLLOW-UP IT WAS LEARNT THAT SURGICAL INTERVENTION WAS NOT REQUIRED AND TREATMENT FOR CORNEAL EDEMA WAS PRESCRIBED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Corneal Edema

  MAUDE report 14322456 ↗
• MalfunctionMay 5, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT BOTTLE HANGER AND FOOT PEDAL IS DAMAGED. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14287766 ↗
• MalfunctionApr 8, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING SURGERY THE PHYSICIAN HAD SOME DIFFICULTY TO MAINTAIN A STABLE CHAMBER. THROUGH FOLLOW UP WE LEARNED THAT AFTER HYDRODISSECTION AND INITIATING OF THE PHACOEMULSIFICATION WITH THE INTRODUCTION OF THE NEEDLE, THERE WAS NO ANTERIOR CHAMBER FORMATION THAT WOULD ALLOW A NORMAL COURSE OF SURGERY. WHENEVER THE PEDAL WAS PRESSED, THE CHAMBER DID NOT FORM AND, WITH THE VACUUM, IT COLLAPSED. ALL THE EQUIPMENT PARAMETERS WERE IN ACCORDANCE WITH THE STANDARD AND RECOMMENDED. INITIALLY, THE HANDPIECE AND NEEDLE, AND LATER THE FLUIDIC WERE UNSUCCESSFULLY REPLACED. THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE BY USING OVD IN LARGE QUANTITIES. IN THE END, CENTRAL ANTERIOR VITRECTOMY WAS NECESSARY. WITH PROLONGED SURGICAL TIME AND INSUFFICIENT ANTERIOR CHAMBER, THE PATIENT HAD A LONGER AND MORE DIFFICULT RECOVERY WITH SIGNIFICANT DECOMPENSATION OF THE ENTIRE CORNEA. NO FURTHER INFORMATION HAS BEEN PROVIDED.

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

  MAUDE report 14058437 ↗
• InjuryMar 25, 2022Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT PATIENT CLAIMED TO HAVE FELT HEAT WHILE SCULPTING A GROOVE IN A NUCLEUS WITH ELLIPS FX HANDPIECE. THE SURGEON ALLEGED HE HAD HEARD SLIGHTLY UNUSUAL NOISE FROM PHACO MACHINE BEFORE HE SENSED THE HEAT FROM THE HANDPIECE. HE IMMEDIATELY TOOK THE TIP OUT FROM THE PATIENT'S EYE. THE INCISION RECEIVED MILD THERMAL BURN. THE SURGEON CONFIRMED THAT THE HANDPIECE BECAME HOT WHEN HE STEPPED FOOTPEDAL. HE REPLACED WITH THE PHACO MACHINE AND EQUIPMENT OF ANOTHER COMPANY¿S PRODUCT, AND THE SURGERY WAS SUCCESSFULLY COMPLETED WITH 10 MINUTES DELAY. THE WOUND WAS NORMALLY CLOSED, THERE WAS NO SUTURE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Corneal Abrasion; Eye Burn; Eye Injury

  MAUDE report 13906132 ↗
• InjuryMar 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CORNEAL BURNS OCCURRED ON A PATIENT. THROUGH FOLLOW-UP WE LEARNED THAT 4 SUTURES WERE REQUIRED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT IS EXPECTED THAT THE PATIENT WILL HAVE STRONG ASTIGMATISM. THE JJSV SALES/APPLICATION TEAM CONTACTED THE CUSTOMER AND IT WAS FOUND THAT THE CUSTOMER USED TOO HIGH PHACO SETTINGS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Eye Burn

  MAUDE report 13831466 ↗
• InjuryMar 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CORNEAL BURNS OCCURRED ON A PATIENT. THROUGH FOLLOW-UP WE LEARNED THAT 2 SUTURES WERE REQUIRED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT IS EXPECTED THAT THE PATIENT WILL HAVE ASTIGMATISM. THE JJSV SALES/APPLICATION TEAM CONTACTED THE CUSTOMER AND IT WAS FOUND THAT THE CUSTOMER USED TOO HIGH PHACO SETTINGS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Eye Burn

  MAUDE report 13831440 ↗
• InjuryFeb 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON HAD A PATIENT WHO HAD VERY DENSE LENSE AND PROBABLY DURING SCULPT HE ACHIEVED A THERMAL INJURY TO THE CORNEA REQUIRING HIM TO HAVE TO SUTURE THE CORNEA AT THE END OF THE CASES. REPORTEDLY PATIENT WAS DOING FINE, BUT AT DAY 1 HE DECIDED TO LEAVE IN SUTURES UNTIL THE 1-WEEK POST OP VISIT. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT SURGEON DECIDED TO LEAVE THE SUTURES FOR LITTLE LONGER. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT CAPTURES INFORMATION FOR THE SECOND PATIENT. ANOTHER REPORT IS BEING SUBMITTED TO CAPTURE INFORMATION FOR THE FIRST PATIENT THAT EXPERIENCED SIMILAR EVENT.

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

  MAUDE report 13579443 ↗
• InjuryFeb 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON HAD A PATIENT WHO HAD VERY DENSE LENSE AND PROBABLY DURING SCULPT HE ACHIEVED A THERMAL INJURY TO THE CORNEA REQUIRING HIM TO HAVE TO SUTURE THE CORNEA AT THE END OF THE CASES. REPORTEDLY PATIENT WAS DOING FINE, BUT AT DAY 1 HE DECIDED TO LEAVE IN SUTURES UNTIL THE 1-WEEK POST OP VISIT. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT SURGEON DECIDED TO LEAVE THE SUTURES FOR LITTLE LONGER. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT CAPTURES INFORMATION FOR ONE PATIENT. ANOTHER REPORT IS BEING SUBMITTED TO CAPTURE INFORMATION FOR A SECOND PATIENT THAT EXPERIENCED SIMILAR EVENT.

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

  MAUDE report 13579399 ↗
• InjuryJul 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON DAMAGED THE CAPSULAR BAG WHILE USING OUR PHACO MACHINE DURING SURGERY. SURGEON NEEDED TO UNDERTAKE AN ANTERIOR VITRECTOMY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 12170238 ↗
• MalfunctionMay 6, 2021Mechanical Problem; Mechanical Problem

  DURING AN INSPECTION OF THE WHITESTAR SIGNATURE EQUIPMENT, THE FIELD SERVICE TECHNICIAN OBSERVED THE IV POLE HANGER WAS DAMAGED. THE BOTTLE HANGER WAS REPLACED. NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11784188 ↗
• MalfunctionSep 30, 2020Thermal Decomposition of Device; Thermal Decomposition of Device

  A SURGERY CENTER REPORTED THERE WAS A BURNT SWITCHING POWER SUPPLY. NO PATIENT INJURY REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10610836 ↗
• MalfunctionSep 21, 2020Smoking; Smoking

  ACCOUNT REPORTED SMOKE EMITTING FROM THE PHACO SYSTEM. A BRIEF DESCRIPTION FROM THE SURGERY CENTER INDICATED THAT THE SYSTEM MONITOR WAS FLICKERING AND THEN THERE WAS SMOKE COMING OUT OF THE EQUIPMENT. THE SYSTEM WAS POWERED DOWN AND SURGERIES WERE POSTPONED. NO PATIENT INVOLVEMENT OR INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10560544 ↗
• InjurySep 14, 2020Unintended Ejection; Device Emits Odor; Unexpected Shutdown; Unintended Ejection; Device Emits Odor; Unexpected Shutdown

  THE SURGERY CENTER REPORTED A CATARACT PATIENT HAD AN UNPLANNED SUTURE PLACED ON INCISION AND WAS PRESENTED WITH CORNEAL OPACIFICATION AND PAIN RESULTING IN MEDICAL TREATMENT OUTSIDE THE NORMAL REGIME. A DESCRIPTION OF THE EVENT IS THAT AFTER THE ANTERIOR CAPSULE INCISION WAS CREATED, THE SOUND OF THE TUBING PACK EJECTING WAS HEARD FROM THE WHITESTAR SIGNATURE PHACO SYSTEM; THE SYSTEM PROCEEDED TO THE END OF THE PROCEDURE AND SHUT DOWN. AT THE SAME MOMENT, THERE WAS A BURNT ODOR. ALTHOUGH, THERE WAS NO VISIBLE SMOKE, THE DECISION WAS MADE TO COMPLETE THE PROCEDURE USING A BACKUP MACHINE. A 3-HOUR DELAY WAS REPORTED WHILE WAITING FOR A BACKUP SYSTEM TO ARRIVE AT THE SITE LOCATION. THE INCISION WAS TEMPORARILY CLOSED WHILE WAITING FOR THE MACHINE ARRIVAL. FOLLOW UP WAS PROVIDED: ON THE DAY OF PROCEDURE, THE SURGEON THOUGHT IT WAS A POTENTIAL RISK FOR PATIENT INJURY. HOWEVER, ON THE DAY 1 POSTOPERATIVELY, IT TURNED OUT THE PATIENT WAS WELL, THE SURGEON WAS RELIEVED. IT WAS EXPLAINED THE OPACIFICATION WAS DUE TO THE DRIED EPITHELIUM, WHICH CAUSED PAIN IN EYE ON THE DAY OF PROCEDURE. HOWEVER, ON THE DAY 1 POSTOPERATIVELY, THE PATIENT DID NOT CLAIM PAIN, AND THE OUTCOME SEEMED WELL.

  Patient problems: No Code Available; Pain

  MAUDE report 10532323 ↗
• MalfunctionSep 11, 2020Smoking; Smoking

  THE SURGERY CLINIC REPORTED THAT DURING START-UP OF THE PHACO SYSTEM, THERE WAS SMOKE FROM COMING OUT OF THE TOP OF THE MONITOR AND A BURNT ODOR WAS DETECTED. THE SURGEON STATED THAT THERE WERE NO ISSUE USING THE SYSTEM, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10522231 ↗
• InjuryMar 16, 2020Obstruction of Flow; Obstruction of Flow

  DURING A CATARACT EXTRACTION PROCEDURE, THE SURGERY CENTER REPORTED WOUND LEAKAGE IN THE PATIENT¿S LEFT OPERATIVE EYE REQUIRING TWO SUTURES TO CLOSE THE WOUND. A BRIEF DESCRIPTION OF THE EVENT IS THAT DURING THE PROCEDURE, THE ANTERIOR CHAMBER FILLED WITH AIR THAT CREATED A BUBBLE AT THE TIP. THE SURGEON¿S COMMENTS WERE OF OBSERVING A MILD CHANGE DURING THE PROCEDURE AND THAT THE WOUND WAS NOT SEALING WHICH RESULTED IN SUTURES TO CLOSE THE WOUND. THE PATIENT OUTCOME IS WELL WITH 20/20 MONOVISION.

  Patient problems: Fluid Discharge

  MAUDE report 9836860 ↗