WHITESTAR SIGNATURE SYSTEM, FUSION PUMP OPO71Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 05050474534445), received between Dec 12, 2016 and Nov 4, 2022 — classified as 21 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (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.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2022Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem; Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT WHEN THE CUSTOMER FOUND A STAIN ON THE OUTSIDE AND ON THE INSIDE OF THE OPO71 PACKAGE. THE CUSTOMER DECIDED TO NOT USE IT. THROUGH FOLLOW UP WE LEARNT THAT THE LID OF THE PACKAGE WAS PROPERLY CLOSED. THE CUSTOMER SAID IT COULD HAVE BEEN AN ISSUE WITH THE SHIPPING BUT HE IS NOT SURE. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15738122 ↗
• InjuryOct 13, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ENDOPHTHALMITIS OCCURRED ON A PATIENT 1 DAY POSTOPERATIVELY. SURGEON SUSPECTED OPO71 (NEXT GENERATION PHACO TUBING DP-PACK) AND HANDPIECE MAY HAVE CAUSED THE ISSUE. THERE WERE NO DETAILS ON THE MEDICATION PRESCRIBED FOR THE PATIENTS. PATIENTS WERE RECOVERING AFTER A WEEK. THIS EVENT WILL CAPTURE PATIENT 2 OUT OF 3 PATIENTS AND FOR THE TUBING PRODUCT. A SEPARATE REPORT IS BEING SUBMITTED FOR THE HANDPIECE DEVICE.

  Patient problems: Endophthalmitis

  MAUDE report 15602080 ↗
• InjuryOct 13, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ENDOPHTHALMITIS OCCURRED ON A PATIENT 1 DAY POSTOPERATIVELY. SURGEON SUSPECTED OPO71 (NEXT GENERATION PHACO TUBING DP-PACK) AND HANDPIECE MAY HAVE CAUSED THE ISSUE. THERE WERE NO DETAILS ON THE MEDICATION PRESCRIBED FOR THE PATIENTS. PATIENTS WERE RECOVERING AFTER A WEEK. THIS EVENT WILL CAPTURE PATIENT 3 OUT OF 3 PATIENTS AND FOR THE TUBING PRODUCT. A SEPARATE REPORT IS BEING SUBMITTED FOR THE HANDPIECE DEVICE.

  Patient problems: Endophthalmitis

  MAUDE report 15602073 ↗
• InjuryOct 13, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ENDOPHTHALMITIS OCCURRED ON A PATIENT 1 DAY POSTOPERATIVELY. SURGEON SUSPECTED OPO71 (NEXT GENERATION PHACO TUBING DP-PACK) AND HANDPIECE MAY HAVE CAUSED THE ISSUE. THERE WERE NO DETAILS ON THE MEDICATION PRESCRIBED FOR THE PATIENTS. PATIENTS WERE RECOVERING AFTER A WEEK. THIS EVENT WILL CAPTURE PATIENT 1 OUT OF 3 PATIENTS AND FOR THE TUBING PRODUCT. A SEPARATE REPORT IS BEING SUBMITTED FOR THE HANDPIECE DEVICE.

  Patient problems: Endophthalmitis

  MAUDE report 15601975 ↗
• MalfunctionApr 8, 2022Delivered as Unsterile Product; Device Damaged Prior to Use; Delivered as Unsterile Product; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE PACKAGING OF THE DEVICE WAS PERFORATED. THIS WAS NOT USED ON A PATIENT. DESPITE SEVERAL FOLLOW UPS, NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14058569 ↗
• InjuryFeb 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT PATIENT HAD SURGERY ON (B)(6) 2021 AND PRESENTED SIX DAYS POST TREATMENT WITH UVEITIS. THIS IS EIGHT OUT OF EIGHT REPORTS/PATIENTS. IT WAS ALSO REPORTED BY THE ACCOUNT THAT SOME OF THE PATIENTS REQUIRED HOSPITALIZATION HOWEVER NO DETAILS WERE PROVIDED OF WHICH PATIENTS REQUIRED IT AND WHICH ONES DID NOT. NO PATIENT DETAILS WERE PROVIDED.

  Patient problems: Uveitis

  MAUDE report 13503827 ↗
• InjuryFeb 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT PATIENT HAD SURGERY ON (B)(6) 2021 AND PRESENTED SIX DAYS POST TREATMENT WITH UVEITIS. THIS IS SEVENTH OUT OF EIGHT REPORTS/PATIENTS. IT WAS ALSO REPORTED BY THE ACCOUNT THAT SOME OF THE PATIENTS REQUIRED HOSPITALIZATION HOWEVER NO DETAILS WERE PROVIDED OF WHICH PATIENTS REQUIRED IT AND WHICH ONES DID NOT. NO PATIENT DETAILS WERE PROVIDED.

  Patient problems: Uveitis

  MAUDE report 13503754 ↗
• InjuryFeb 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT PATIENT HAD SURGERY ON (B)(6) 2021 AND PRESENTED SIX DAYS POST TREATMENT WITH UVEITIS. THIS IS SIXTH OUT OF EIGHT REPORTS/PATIENTS. IT WAS ALSO REPORTED BY THE ACCOUNT THAT SOME OF THE PATIENTS REQUIRED HOSPITALIZATION HOWEVER NO DETAILS WERE PROVIDED OF WHICH PATIENTS REQUIRED IT AND WHICH ONES DID NOT. NO PATIENT DETAILS WERE PROVIDED.

  Patient problems: Uveitis

  MAUDE report 13503715 ↗
• InjuryFeb 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT PATIENT HAD SURGERY ON (B)(6) 2021 AND PRESENTED SIX DAYS POST TREATMENT WITH UVEITIS. THIS IS FIFTH OUT OF EIGHT REPORTS/PATIENTS. IT WAS ALSO REPORTED BY THE ACCOUNT THAT SOME OF THE PATIENTS REQUIRED HOSPITALIZATION HOWEVER NO DETAILS WERE PROVIDED OF WHICH PATIENTS REQUIRED IT AND WHICH ONES DID NOT. NO PATIENT DETAILS WERE PROVIDED.

  Patient problems: Uveitis

  MAUDE report 13503676 ↗
• InjuryFeb 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT PATIENT HAD SURGERY ON (B)(6) 2021 AND PRESENTED SIX DAYS POST TREATMENT WITH UVEITIS. THIS IS FOURTH OUT OF EIGHT REPORTS/PATIENTS. IT WAS ALSO REPORTED BY THE ACCOUNT THAT SOME OF THE PATIENTS REQUIRED HOSPITALIZATION HOWEVER NO DETAILS WERE PROVIDED OF WHICH PATIENTS REQUIRED IT AND WHICH ONES DID NOT. NO PATIENT DETAILS WERE PROVIDED.

  Patient problems: Uveitis

  MAUDE report 13503602 ↗
• InjuryFeb 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT PATIENT HAD SURGERY ON (B)(6) 2021 AND PRESENTED SIX DAYS POST TREATMENT WITH UVEITIS. THIS IS THREE OUT OF EIGHT REPORTS/PATIENTS. IT WAS ALSO REPORTED BY THE ACCOUNT THAT SOME OF THE PATIENTS REQUIRED HOSPITALIZATION HOWEVER NO DETAILS WERE PROVIDED OF WHICH PATIENTS REQUIRED IT AND WHICH ONES DID NOT. NO PATIENT DETAILS WERE PROVIDED.

  Patient problems: Uveitis

  MAUDE report 13503562 ↗
• InjuryFeb 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT PATIENT HAD SURGERY ON (B)(6) 2021 AND PRESENTED SIX DAYS POST TREATMENT WITH UVEITIS. THIS IS 2 OUT OF EIGHT REPORTS/PATIENTS. IT WAS ALSO REPORTED BY THE ACCOUNT THAT SOME OF THE PATIENTS REQUIRED HOSPITALIZATION HOWEVER NO DETAILS WERE PROVIDED OF WHICH PATIENTS REQUIRED IT AND WHICH ONES DID NOT. NO PATIENT DETAILS WERE PROVIDED.

  Patient problems: Uveitis

  MAUDE report 13503501 ↗
• InjuryFeb 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT PATIENT HAD SURGERY ON (B)(6) 2021 AND PRESENTED SIX DAYS POST TREATMENT WITH UVEITIS. THIS IS ONE OF EIGHT REPORTS/PATIENTS. IT WAS ALSO REPORTED BY THE ACCOUNT THAT SOME OF THE PATIENTS REQUIRED HOSPITALIZATION HOWEVER NO DETAILS WERE PROVIDED OF WHICH PATIENTS REQUIRED IT AND WHICH ONES DID NOT. NO PATIENT DETAILS WERE PROVIDED.

  Patient problems: Uveitis

  MAUDE report 13503459 ↗
• InjuryFeb 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT PATIENT HAD SURGERY ON (B)(6) 2021 AND PRESENTED SIX DAYS POST TREATMENT WITH UVEITIS.

  Patient problems: Uveitis

  MAUDE report 13503282 ↗
• MalfunctionDec 31, 2019Unsealed Device Packaging; Unsealed Device Packaging

  A SURGERY CENTER REPORTED OBSERVING THE TYVEK LID PARTIALLY OPEN ON THE TRAY OF A SIGNATURE DISPOSABLE TUBING SET PACK MODEL OPO71. IT WAS REPORTED THE OBSERVATIONS WERE NOTED UPON OPENING THE BOX. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9535099 ↗
• InjuryApr 12, 2019Inaccurate Flow Rate; Inaccurate Flow Rate

  DURING A CATARACT PROCEDURE, A RUPTURE CAPSULE OCCURRED ON THE OPERATIVE EYE RESULTING IN A VITRECTOMY PROCEDURE WHEN USING THE DISPOSABLE TUBING PACK MODEL OPO71. A DESCRIPTION FROM THE SURGERY CENTER INDICATED DURING THE IRRIGATION AND ASPIRATION (I/A) SEGMENT OF THE CATARACT PROCEDURE, THERE WAS CHAMBER INSTABILITY. THE SURGERY CENTER INDICATED AFTER THE CAPSULAR RUPTURE OCCURRED, THE SURGERY CENTER CHANGED TO LOW SETTINGS ON THE REMAINING PROCEDURES TO PREVENT ANY MORE RUPTURES. PROCEDURE WAS COMPLETED, AND PATIENT OUTCOME IS WELL. THE TUBING FOR THE EVENT WAS DISCARDED.

  Patient problems: Capsular Bag Tear; Vitrectomy

  MAUDE report 8511843 ↗
• InjuryFeb 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A CATARACT EXTRACTION PROCEDURE, THE SURGERY REPORTED TWO PATIENTS HAD CAPSULAR TEAR OCCUR IN THE OPERATIVE EYE WHEN USING THE OPO71 DISPOSABLE TUBING PACK. A DESCRIPTION FROM THE SURGERY CENTER INDICATED OUT OF 7 CASES, THEY HAD 2 CAPSULAR TEARS AND IN 2 OTHER CASES, THEY HAD UNSTABLE CHAMBER. IT IS UNKNOWN IF THERE WAS SURGICAL OR MEDICAL INTERVENTION REQUIRED. ALTHOUGH SEVERAL ATTEMPTS WERE MADE FOR ADDITIONAL INFORMATION, NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS 1 OF 2 REPORTS.

  Patient problems: Capsular Bag Tear

  MAUDE report 8368610 ↗
• InjuryFeb 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A CATARACT EXTRACTION PROCEDURE, THE SURGERY REPORTED TWO PATIENTS HAD CAPSULAR TEAR OCCUR IN THE OPERATIVE EYE WHEN USING THE OPO71 DISPOSABLE TUBING PACK. A DESCRIPTION FROM THE SURGERY CENTER INDICATED OUT OF 7 CASES, THEY HAD 2 CAPSULAR TEARS AND IN 2 OTHER CASES, THEY HAD UNSTABLE CHAMBER. IT IS UNKNOWN IF THERE WAS SURGICAL OR MEDICAL INTERVENTION REQUIRED. ALTHOUGH SEVERAL ATTEMPTS WERE MADE FOR ADDITIONAL INFORMATION, NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS 2 OF 2 REPORTS.

  Patient problems: Capsular Bag Tear

  MAUDE report 8368605 ↗
• InjuryApr 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A CATARACT EXTRACTION PROCEDURE, THE SURGERY CENTER REPORTED A CAPSULAR TEAR RESULTING IN A VITRECTOMY SURGICAL PROCEDURE. THE SURGERY CENTER INDICATED THE CHAMBER COLLAPSE AND THE LENS WAS ASPIRATED. THE SURGERY CENTER INDICATED THE ANTERIOR CHAMBER COLLAPSE OCCURRED IN PHACO, BUT PHACO FINISHED WITHOUT NOTICING POSTERIOR CAPSULE BREAKAGE. IT IS UNKNOWN WHETHER IT BROKE AT THE TIME OF ANTERIOR CHAMBER COLLAPSE, OR WHETHER IT HAD BROKEN BEFORE IT. AFTER THAT SURGEON NOTICED A BROKEN BLADDER AT THE TIME OF IRRIGATION AND ASPIRATION SEGMENT, BUT SUDDEN REMOVAL WITH BLADDER BECAUSE THE BLADDER WAS ERRONEOUSLY ASPIRATED AND THE ZONULES WERE BROKEN. A VITRECTOMY PROCEDURE WAS PERFORMED. THE WOUND WAS EXPANDED TO ABOUT 2.8 MM TO 4.0 MM AND THE IOL WAS SUTURED TO THE CILIARY BODY. THIS REPORT IS FOR THE TUBING PACK. A SEPARATE REPORT WILL BE SUBMITTED FOR THE PHACOFRAGMENTATION UNIT.

  Patient problems: Capsular Bag Tear; Vitrectomy

  MAUDE report 7466848 ↗
• InjurySep 26, 2017Partial Blockage; Kinked; Partial Blockage; Kinked

  IT WAS REPORTED THAT DURING CATARACT EXTRACTION IN LEFT EYE THE CARTRIDGE TUBING (OPO71 WHITESTAR SIGNATURE FUSION FLUIDICS) OCCLUDED DUE TO A KINK IN THE LINE. THIS RESULTED IN LOSS OF CHAMBER (CHAMBER COLLAPSE) AND THE POSTERIOR CAPSULE WAS GRABBED BY THE IRRIGATION/ASPIRATION HAND PIECE TIP. TUBING WAS CHANGED TO COMPLETE THE CASE ON THE SAME DAY. IT WAS REPORTED THAT THERE WAS INCISION ENLARGEMENT, SUTURES WERE DONE AND VITRECTOMY WAS REQUIRED. PATIENT REPORTED BEING ANXIOUS AND HAVING BLURRY VISION POST OP.

  Patient problems: Blurred Vision; Capsular Bag Tear; Vitrectomy

  MAUDE report 6892920 ↗
• InjuryAug 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE CATARACT PROCEDURE USING OPO71 PATIENT PRESENTED WITH TASS (TOXIC ANTERIOR SEGMENT SYNDROME) AND EDEMA AND MEDICAL INTERVENTION WAS REQUIRED. THE DESCEMET'S MEMBRANE EDEMA WAS RESOLVED BY PRESCRIBING STEROID EYE DROPS

  Patient problems: Corneal Edema; No Code Available

  MAUDE report 6806634 ↗
• InjuryAug 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE CATARACT PROCEDURE USING OPO71 PATIENT PRESENTED WITH TASS (TOXIC ANTERIOR SEGMENT SYNDROME) AND EDEMA AND MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Corneal Edema; No Code Available

  MAUDE report 6806633 ↗
• InjuryAug 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SURGERY CENTER REPORTED A CATARACT PATIENT PRESENTED WITH TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WHEN USING THE SINGLE PACK DISPOSABLE TUBING MODEL OPO71. A BRIEF DESCRIPTION FROM THE SURGERY CENTER INDICATED THE PATIENT HAD DESCEMET MEMBRANE EDEMA SYMPTOM AND STEROID EYE DROPS WERE PRESCRIBED. THE SURGERY CENTER REPORTED THE PATIENT HAD RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6778066 ↗
• InjuryDec 12, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING A CATARACT EXTRACTION PROCEDURE, THE SURGERY CENTER REPORTED A POSTERIOR CAPSULE RUPTURE REQUIRING A VITRECTOMY PROCEDURE. A BRIEF DESCRIPTION FROM THE SURGERY CENTER INDICATED THE CAPSULAR RUPTURE OCCURRED BEFORE THE POSITION TWO WAS ACTIVATED ON THE FOOTPEDAL WHEN USING THE DISPOSABLE TUBING PACK. THE SURGERY CENTER REPORTED THE PROCEDURE WAS DELAYED FOR ABOUT 30 MINUTES.

  Patient problems: Capsular Bag Tear; Vitrectomy

  MAUDE report 6165570 ↗