WHITESTAR SIGNATURE PRORecalls & reported problems across all models

We found 2 models of WHITESTAR SIGNATURE PRO by Johnson & Johnson Surgical Vision, Inc. in the FDA's device registry (GUDID). Together they are named in 151 adverse event reports in the FDA's MAUDE database, received between Nov 21, 2016 and Mar 4, 2026 — classified as 137 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (27 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported WHITESTAR SIGNATURE PRO problems

WHITESTAR SIGNATURE PRO models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• WHITESTAR SIGNATURE PRO NGP680301

  Unit, phacofragmentation
  147 reports
• WHITESTAR SIGNATURE PRO NGP680703

  Unit, phacofragmentation
  4 reports

Recent WHITESTAR SIGNATURE PRO adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2026Unexpected Shutdown

  IT WAS REPORTED THAT, DURING A SURGICAL PROCEDURE USING THE SIGNATURE PRO MACHINE, THE DEVICE WENT COMPLETELY BLACK AND TURNED OFF DURING THE CHOP STAGE. A FEW SECONDS LATER, THE MACHINE RESTARTED ON THE SAME SCREEN, BUT THE SURGICAL TEAM HAD TO PRIME AND TUNE THE TUBINGS AGAIN. AS A RESULT OF THE DEVICE ISSUE, THERE WAS A COLLAPSE OF THE EYE AND A SMALL RUPTURE, WHICH REQUIRED A VITRECTOMY. FROM EVENT LOG: 6983B0EB (B)(6) 2026 / 12:49:47 353 353 IH TO GUI COMMUNICATION ERROR. THE PATIENT RECOVERED AFTER SURGERY, IT WAS REPORTED THAT IT WAS A DIFFICULT PATIENT FROM THE BEGINNING, BUT THE SURGEON'S SKILLS SAVED ANY FUTURE ISSUES. THE PROCEDURE WAS DELAYED BY 5¿10 MINUTES. THROUGH FOLLOW UP WE LEARNED THE POSTERIOR CAPSULE WAS RUPTURED. NO DETAILS AVAILABLE FOR THE TUBING PACK, HANDPIECE AND NEEDLE. THERE WAS NO MATERIAL AVAILABLE FOR FURTHER INVESTIGATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; Zonular Dehiscence

  MAUDE report 24508356 ↗
• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6), 2025 THERE WAS AN ISSUE THAT OCCURRED WHERE A SURGICAL WOUND WOULD NOT SEAL FOLLOWING A STANDARD PROCEDURE. THE EFFECTIVE PHACOEMULSIFICATION SETTING WAS 6.3, AND A DISPOSABLE PHACO TIP WAS USED. THROUGH FOLLOW UP IT WAS LEARNED THAT THERE WAS A SMALL CORNEAL BURN, MAIN INCISION, ON PATIENT'S LEFT EYE THAT REQUIRED SUTURING. DOCTOR PLACED 1 10-0 NYLON SUTURE. PATIENT CONTINUES TO HAVE A SCAR. MOXIFLOXACIN DROPS WERE PRESCRIBED WHICH WERE OUTSIDE STANDARD OF CARE. PATIENT WAS SEEN ON (B)(6) 2026 AND THE SUTURE WAS REMOVED. PATIENT WILL BE RETURNING FOR REFRACTION IN THE NEXT FEW WEEKS. WITH THE SUTURE, PATIENT WAS 20/30 DISTANCE UNCORRECTED. NO ADDITIONAL INFORMATION WAS PROVIDED. NOTE: THIS REPORT IS AGAINST THE WHITESTAR. SEPARATE REPORTS WILL BE FILED AGAINST THE HANDPIECE, TIP, TUBING.

  Patient problems: Corneal Clouding/Hazing; Eye Burn; Wound Dehiscence

  MAUDE report 24382901 ↗
• MalfunctionDec 15, 2025Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT THE SYSTEM WAS POWERING DOWN INTERMITTENTLY DURING CASES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23812793 ↗
• InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAPSULE RUPTURE OCCURRED DURING A PROCEDURE. THROUGH FOLLOW UP WE LEARNED THAT THE CAPSULAR RUPTURE OCCURRED INTRAOPERATIVELY WHILE THE PATIENT WAS UNDERGOING PHACOEMULSIFICATION USING A SIGNATURE PRO DEVICE PRIOR TO INTRAOCULAR LENS (IOL) IMPLANTATION. THE TEAM REPORTED THE RUPTURE WAS ATTRIBUTED TO PATIENT MOVEMENT. AN ANTERIOR VITRECTOMY WAS PERFORMED AND A SECONDARY IMPLANTATION OF AN AR40E INTRAOCULAR LENS WAS COMPLETED. NO ADDITIONAL DETAILS WERE PROVIDED. NOTE: THIS REPORT IS FOR THE PHACO SYSTEM. SEPARATE REPORTS WILL BE SUBMITTED FOR THE PHACO HANDPIECE AND PHACO TIP.

  Patient problems: Capsular Bag Tear

  MAUDE report 23769854 ↗
• 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 ↗
• InjuryAug 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A CORNEAL BURN ON THE RIGHT EYE WHICH REQUIRED SUTURES. PATIENT IS STABLE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS AGAINST THE WHITESTAR. A SEPARATE REPORT WILL BE FILED AGAINST THE HANDPIECE, TIP, TUBING.

  Patient problems: Eye Burn

  MAUDE report 22821413 ↗
• InjuryJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SINGLE CENTER, NONRANDOMIZED CLINICAL STUDY WAS DONE TO COMPARE THE EFFICIENCY OF VENTURI AND PERISTALTIC PUMP PHACOEMULSIFICATION SYSTEMS IN PATIENTS UNDERGOING ROUTINE LASER CATARACT SURGERY. A TOTAL OF 995 EYES UNDERWENT ROUTINE LASER CATARACT SURGERY (LCS) (521 EYES UNDERWENT LCS WITH VENTURI-BASED VACUUM AND 474 EYES UNDERWENT LCS WITH PERISTALTIC VACUUM). EACH SURGERY WAS TREATED WITH A CATALYS LASER SYSTEM (JOHNSON & JOHNSON VISION) (DEVICE IN SCOPE) AND A WHITESTAR SIGNATURE PRO PHACOEMULSIFICATION SYSTEM (JOHNSON & JOHNSON VISION). DURING THE PROCEDURE, THE LENS WAS SPLIT INTO TWO HEMISPHERES BY ¿ENDOLENTICULAR VISCODISSECTION¿ (WJS) USING HEALON (JOHNSON & JOHNSON) ON A 30-GAUGE CANNULA OR BY A QUICK-CHOP TECHNIQUE ALONG THE CENTRAL LASER SEGMENTATION LINE. IN THE VENTURI GROUP, INTRAOPERATIVE COMPLICATIONS REPORTED INCLUDE POSTERIOR CAPSULE BREAK WITHOUT VITREOUS LOSS (N=1 EYE) AND ANTERIOR CAPSULE TEAR (N=2 EYES) WHILE IN THE PERISTALTIC GROUP, INTRAOPERATIVE COMPLICATIONS REPORTED INCLUDE POSTERIOR CAPSULE BREAK WITHOUT VITREOUS LOSS (N=1 EYE) AND ANTERIOR CAPSULE TEAR (N=1 EYE). THERE WERE NO CLEAR DISTINCTION ON WHICH EVENTS WERE ATTRIBUTED TO WHICH DEVICE. THERE A

  Patient problems: Capsular Bag Tear

  MAUDE report 22470452 ↗
• InjuryMay 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE OPERATION, THE PHACO WOUND WAS LEAKING, AND THE SURGEON SUSPECTED A POSSIBLE PHACO BURN. FOLLOWING WOUND HYDRATION, THE CONDITION OF THE WOUND IMPROVED. THE PATIENT IS FULLY RECOVERED WITH NO SIGNIFICANT IMPACT ON DAILY ACTIVITIES. THROUGH FOLLOW-UP WE LEARNED THAT THE PHACO BURN WAS OBSERVED IN THE PATIENT'S CORNEA. THE PROCEDURE WAS COMPLETED IN THE SAME DAY WITH NO MEDICAL OR SURGICAL INTERVENTIONS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Burn; Wound Dehiscence

  MAUDE report 22054096 ↗
• InjuryJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED A THERMAL INJURY TO THE CORNEA OCCURRED DURING A SURGICAL PROCEDURE. THE INCIDENT INVOLVED DR. (B)(6) WHO EXPERIENCED A PHACO BURN AND USED A SUTURE TO CLOSE THE INCISION. THE EVENT LOG SUGGESTS THAT THE SURGEON MAY HAVE MISTAKENLY BELIEVED HE WAS ON THE QUADRANT SETTING BUT WAS ACTUALLY ON THE SCULPT SETTING. THIS CAUSED THE HEALON 5 IN THE EYE TO PLUG THE PHACO TIP, RESULTING IN INSUFFICIENT VACUUM AND TIP HEATING. FOLLOWING THE INCIDENT, THE PATIENT WAS RE-EVALUATED AND FOUND TO HAVE AN INTRAOCULAR PRESSURE OF 12, WITH EDEMA LIMITED TO THE INCISION AREA, A CLEAR CENTRAL CORNEA, A FORMED CHAMBER, AND IMPROVING VISION. NO FURTHER INFORMATION PROVIDED. THIS IS REPORT 1 OF 4.

  Patient problems: Corneal Edema; Eye Burn

  MAUDE report 21085811 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WERE CASES OF POSTOPERATIVE CORNEAL ENDOTHELIAL LOSS. THE NUMBER OF CASES AND THE DETAILS OF THE INTRAOCULAR LENS IMPLANTED ARE UNKNOWN. THE ULTRASONIC OSCILLATION SETTING OF THE EQUIPMENT WAS RECENTLY CHANGED, BUT IT MAY BE ATTRIBUTABLE TO THE OPHTHALMIC VISCOSURGICAL DEVICE (OVD) USED. THE TWO OVDS USED DURING SURGERY ARE FROM DIFFERENT MANUFACTURERS, AND THE ISSUE OCCURRED WHEN ONLY ONE OF THEM WAS USED WITHOUT COMBINING THEM. THERE WERE NO PATIENT INJURIES, AND NO OTHER MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Corneal Endothelial Cell Loss

  MAUDE report 20042301 ↗
• InjuryJun 12, 2024Suction Problem; Suction Problem

  IT WAS REPORTED THAT PHACO SIGNATURE PRO HAD AN INITIAL PROBLEM WITH THE OPO71 CASSETTE AND WAS NOT WORKING PROPERLY. THE CASSETTE WAS THEN CHANGED TO THE OPO73, WHERE THE SURGERY WAS STARTED CORRECTLY. PRIME AND TUNED OK AND DURING THE FIRST SURGERY THE PHACO SHOWED A LOT OF SURGES, RUPTURING THE CAPSULE AND REQUIRING INTERVENTION WITH VITRECTOMY. LENS WAS IMPLANTED AND DOCTOR WILL MONITOR AND EVALUATE PROGRESS IN POSTOP. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 19522872 ↗
• InjuryDec 27, 2023Suction Problem; Infusion or Flow Problem; Suction Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THERE WAS A CASE OF SUDDEN POSTERIOR VESICLE DAMAGE WHICH OCCURRED DURING IRRIGATION/ASPIRATION (IA) STEP FOR REMOVAL OF OPHTHALMIC VISCOSURGICAL DEVICE (OVD) ON THE PATIENT'S RIGHT EYE. THE DOCTOR THINKS THERE IS A POSSIBILITY THAT THERE IS A PROBLEM WITH THE SUCTION OF IA DUE TO THE IA TIP. THE PHYSICIAN HAS BEEN USING SIGPRO FOR MORE THAN THREE YEARS, BUT THIS IS THE FIRST TIME TO HAVE THESE ISSUES. THROUGH FOLLOW-UP WE LEARNED, THAT AN ISTENT WAS USED AND POSTERIOR CAPSULE DAMAGE DURING OVD REMOVAL AFTER INTRAOCULAR LENS (IOL) IMPLANTATION. THE IOL IMPLANTED WAS A DFW375 SERIAL NUMBER: (B)(6) DUE TO PATIENT INJURY THIS LENS WAS EXPLANTED, AND THE FOLLOWING LENS WAS IMPLANTED: AR40E 21.5D SERIAL NUMBER: (B)(6). DIAMOX WAS PRESCRIBED DUE TO INCREASED INTRAOCULAR PRESSURE. A VITRECTOMY WAS PERFORMED AND THE INCISION TO THE EYE WAS ENLARGED, REQUIRING SUTURES. THE OPERATION ON THE PATIENT'S LEFT EYE WAS POSTPONED. NO OTHER COMPLICATIONS WERE REPORTED AND HEALON NA 0.85 WAS USED FOR THESE CASE WITHOUT ISSUES RELATED TO IT. NO FURTHER DETAILS WERE PROVIDED. A SEPARATE REPORT IS BEING SUBMITTED FOR THE OTHER JNJ DEVICE INVOLVED FOR THIS PATIENT.

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

  MAUDE report 18400970 ↗
• InjurySep 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DOCTOR CONVERTED TO VITRECTOMY DURING PHACO PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17726198 ↗
• InjuryJul 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHILE SURGEON WAS SCULPTING ON A VERY DENSE LENS WITH A NEW 21GA NEEDLE AND HAD A SMALL THERMAL INJURY TO THE CORNEA. THE INCISION DID SEAL AT THE END OF THE CASE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Eye Burn

  MAUDE report 17308637 ↗
• MalfunctionJun 16, 2023Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT THE SYSTEM SHUTS DOWN INTERMITTENTLY DURING SURGERY. THERE WAS NO INFORMATION IF THEY WERE ABLE TO COMPLETE THE PROCEDURE DURING THE SAME VISIT. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17146518 ↗

Other Johnson & Johnson Surgical Vision, Inc. products

• TECNIS IOL1,344 models · 10,702 reports · 3 recalls
• FS DISPOSABLE INTERFACE2 models · 4,239 reports
• TECNIS SIMPLICITY112 models · 2,730 reports · 1 recall
• SENSAR IOL112 models · 1,213 reports
• TECNIS CL IOL42 models · 558 reports
• TECNIS ODYSSEY IOL49 models · 389 reports
• TECNIS ODYSSEY TORIC II IOL106 models · 285 reports
• UNFOLDER EMERALD2 models · 258 reports