WHITESTAR SIGNATURE PRO NGP680703Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474596122), received between Jan 24, 2019 and Aug 15, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Accessory Incompatible” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPARATIVE CLINICAL STUDY OF SURGICAL PERFORMANCE OF QUATERA 700 VERSUS CENTURIONAND SIGNATURE PRO PHACOEMULSIFICATION SYSTEMS. A PROSPECTIVE, INTERVENTIONAL, 3-ARM, RANDOMIZED COMPARISON STUDY WAS DONE TO COMPARE THE INTRA-OPERATIVE SURGICAL PERFORMANCE OF QUATERA 700 WITH CENTURION AND SIGNATURE PRO PHACOEMULSIFICATION SYSTEMS. A TOTAL OF 180 NON-CONSECUTIVE EYES FROM 151 PATIENTS WERE RECRUITED FOR THE STUDY (N=60 EYES IN THE QUATERA 700 GROUP, 60 EYES IN THE CENTURON GROUP, AND 60 EYES IN THE SIGNATURE PRO GROUP). THE WHITESTAR SIGNATURE PRO (JOHNSON AND JOHNSON VISION) SYSTEM WAS USED IN A TOTAL OF 60 EYES (N=30 EYES EACH OF LENS OPACITIES CLASSIFICATION (LOCS) III GRADES 1¿2 (SOFT CATARACT GROUP) AND GRADES 3¿4 (DENSE CATARACT) NUCLEAR DENSITY). IT WAS REPORTED THAT IN THE SOFT CATARACT GROUP, ONE EYE OPERATED WITH THE SIGNATURE PRO HAD POSTERIOR CAPSULE RUPTURE (PCR), DUE TO INADVERTENT SURGE NOTED INTRA-OPERATIVELY. THE % ECD (ENDOTHELIAL CELL DENSITY) LOSS AT 6 MONTHS POST-OP, COMPARED TO PRE-OP FOR THE SIGNATURE PRO IN THE SOFT CATARACT GROUP WAS 11.9% WHILE IN THE DENSE CATARACT GROUP, THE % ECD LOSS WAS AT 14.5%. THERE ARE NO INDICATIONS IN THE ARTICLE OF ANY INTERVENT

  Patient problems: Capsular Bag Tear; Corneal Endothelial Cell Loss

  MAUDE report 22821535 ↗
• InjuryMay 19, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING PROCEDURE, IT WAS UNABLE TO STOP ASPIRATION AND IRRIGATION, WHEN THE FOOTPEDAL WAS RELEASED. IT WAS UNABLE TO ACTIVATE BACKFLUSH. AS A RESULT, THE ANTERIOR CHAMBER BECAME UNSTABLE, HOWEVER, THERE WAS NO POSTERIOR CAPSULE RAPTURE. DOCTOR SWITCHED THE FOOTPEDAL FROM WIRELESS TO WIRED MODE AND REBOOTED, HOWEVER, THE ISSUE WAS NOT RESOLVED. IT GOT A PEDAL ERROR LIKE "IT'S STILL BEING PRESSED". THEN, CUSTOMER DETACHED AND REATTACHED ALL EQUIPMENT, TRIED IT FROM THE BEGINNING, AND THE MACHINE STARTED WORKING, AND PROCEDURE WAS SUCCESSFULLY COMPLETED WITH 60 MINUTES DELAY. ANTERIOR VITRECTOMY CUTTER WAS USED TO TREAT. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT VISUAL ACUITY OF THE PATIENT DECREASED FROM 0.05 (PRE-OP) TO 0.02 (POST OP). IT WAS ALSO DIAGNOSED THAT PATIENT HAD BULLOUS KERATOPATHY AND DECREASED CORNEAL ENDOTHELIAL CELL. REPORTEDLY SUBCONJUNCTIVAL INJECTION OF DEXART WAS GIVEN FOR INFLAMMATION TO SUBSIDE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Corneal Clouding/Hazing; Eye Injury

  MAUDE report 16970274 ↗
• InjuryOct 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LOST COMMUNICATION BETWEEN THE FOOTPEDAL AND PHACO SYSTEM RESULTING IN AN UNPLANNED VITRECTOMY WAS REPORTED. A BRIEF DESCRIPTION FROM THE SURGERY CENTER INDICATED THAT DURING CATARACT REMOVAL SURGERY ON (B)(6) 2020, THE FOOTPEDAL AND PHACO MACHINE LOST COMMUNICATION DURING A DENSE CATARACT PROCEDURE OF A MALE PATIENT¿S RIGHT EYE (OD). VITRECTOMY WAS REQUIRED. THE CATARACT SURGERY WAS COMPLETED USING THE SAME PHACO CONSOLE. THIS REPORT IS FOR THE WHITESTAR SIGNATURE PRO ADV LINEAR PEDAL. A SEPARATE REPORT WILL BE SUBMITTED FOR THE WHITESTAR SIGNATURE PRO ADV LINEAR CONSOLE.

  Patient problems: Vitrectomy

  MAUDE report 10729543 ↗
• InjuryJan 24, 2019Accessory Incompatible; Physical Resistance/Sticking; Accessory Incompatible; Physical Resistance/Sticking

  DURING A CATARACT EXTRACTION PROCEDURE, THE SURGERY CENTER REPORTED A POSTERIOR CAPSULAR RUPTURE IN THE PATIENT¿S OPERATIVE EYE REQUIRING AN ANTERIOR VITRECTOMY PROCEDURE WHEN USING THE FOOTPEDAL ACCESSORY AND SIGNATURE PRO CONSOLE. A BRIEF DESCRIPTION FROM THE SURGERY CENTER REPORTED THERE WAS UNSTABLE CHAMBER DURING PROCEDURE AND THE FOOTPEDAL WAS STUCK AND NOT WORKING PROPERLY. IT WAS REPORTED THE PATIENT OUTCOME IS WELL. VISUAL ACUITY PRE AND POST MEASUREMENTS: VISUAL ACUITY PRE-OPERATIVE: 0,3; VISUAL ACUTIY POST-OPERATIVE: 0,6. THIS REPORT IS FOR THE FOOTPEDAL EQUIPMENT. A SEPARATE REPORT WILL BE SUBMITTED FOR THE PHACOEMULSIFICATION CONSOLE.

  Patient problems: Capsular Bag Tear; Vitrectomy

  MAUDE report 8276086 ↗