WHITESTAR SIGNATURERecalls & reported problems across all models

We found 5 models of WHITESTAR SIGNATURE by Johnson & Johnson Surgical Vision, Inc. in the FDA's device registry (GUDID). Together they are named in 174 adverse event reports in the FDA's MAUDE database, received between Sep 12, 2016 and Jul 17, 2026 — classified as 121 injuries, 53 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (22 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

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

WHITESTAR SIGNATURE recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Dec 7, 2022Open, Classified

   Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpieces during surgery, which could result in surgical delay and/or longer surgical time, which could result in transient corneal edema.

   Z-1006-2023 · Root cause: Process control · Recall details · FDA record ↗

Most reported WHITESTAR SIGNATURE problems

WHITESTAR SIGNATURE models

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

• WHITESTAR SIGNATURE NGP680300

  Unit, phacofragmentation
  126 reports
• WHITESTAR SIGNATURE OPO73

  Unit, phacofragmentation
  1 recall43 reports
• WHITESTAR SIGNATURE OPO70

  Unit, phacofragmentation
  2 reports
• WHITESTAR SIGNATURE NGP680702

  Unit, phacofragmentation
  2 reports
• WHITESTAR SIGNATURE NGP680701

  Unit, phacofragmentation
  1 report

Recent WHITESTAR SIGNATURE adverse event reports

The 15 most recent reports across all models, 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 ↗
• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER THAT PPG ST MARY¿S PORTSMOUTH HAS IDENTIFIED A BACTERIAL INFECTION AFFECTING THEIR OPHTHALMOLOGY PATIENTS. AT THIS TIME, IT IS NOT KNOWN WHETHER THE INFECTION IS RELATED TO THE COMPANY¿S LENSES, BUT THE HOSPITAL HAS NOTIFIED ALL OPHTHALMOLOGY SUPPLIERS AS A PRECAUTION. THROUGH FOLLOW UP WE LEARNED THAT A TOTAL OF FIVE PATIENTS WERE AFFECTED BY SUSPECTED ENDOPHTHALMITIS, SPECIFIC DATES BELOW. ALL FIVE PATIENTS WERE TREATED WITH INTRAVITREAL ANTIBIOTICS, ORAL AND TOPICAL ANTIBIOTICS AND ONE PATIENT ALSO REQUIRED TOPICAL STEROIDS. AS WE CANNOT RULE OUT ANY PRODUCTS, ALL SUSPECT PRODUCTS ARE REPORTED WITH ALL INTERVENTIONS PROVIDED. AT PRESENT THERE ARE NO LONG-TERM EFFECTS ON THE PATIENT'S VISION AND NO FURTHER INTERVENTIONS HAVE BEEN REQUIRED. (B)(6) 2026: INTRAVITREAL ANTIBIOTICS, STEROIDS AND TOPICAL ANTIBIOTICS ONLY (B)(6) 2026: INTRAVITREAL ANTIBIOTICS, ORAL AND TOPICAL ANTIBIOTICS ONLY. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Endophthalmitis

  MAUDE report 25453293 ↗
• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER THAT (B)(6) HAS IDENTIFIED A BACTERIAL INFECTION AFFECTING THEIR OPHTHALMOLOGY PATIENTS. AT THIS TIME, IT IS NOT KNOWN WHETHER THE INFECTION IS RELATED TO THE COMPANY¿S LENSES, BUT THE HOSPITAL HAS NOTIFIED ALL OPHTHALMOLOGY SUPPLIERS AS A PRECAUTION. THROUGH FOLLOW UP WE LEARNED THAT A TOTAL OF FIVE PATIENTS WERE AFFECTED BY SUSPECTED ENDOPHTHALMITIS, SPECIFIC DATES BELOW. ALL FIVE PATIENTS WERE TREATED WITH INTRAVITREAL ANTIBIOTICS, ORAL AND TOPICAL ANTIBIOTICS AND ONE PATIENT ALSO REQUIRED TOPICAL STEROIDS. AS WE CANNOT RULE OUT ANY PRODUCTS, ALL SUSPECT PRODUCTS ARE REPORTED WITH ALL INTERVENTIONS PROVIDED. AT PRESENT THERE ARE NO LONG-TERM EFFECTS ON THE PATIENT'S VISION AND NO FURTHER INTERVENTIONS HAVE BEEN REQUIRED. THROUGH FURTHER FOLLOW UP WE LEARNED THE SUSPECT PRODUCTS FOR THESE COMPLAINTS ARE GCB INTRAOCULAR LENS (IOL), LAMINAR FLOW PHACO TIPS, PHACO HANDPIECE, TUBING SETS AND (B)(6) WERE USED ON EACH PATIENT. THERE WAS NO DIFFERENTIATION AS TO WHICH PATIENT HAD WHICH SPECIFIC DEVICE AND AS SUCH, ALL FILES WILL REMAIN CODED WITH TOPICAL STEROIDS. AS WE CANNOT IDENTIFY THE PHACO HANDPIECE USED IN CONJUNCTION WITH THIS SPECIFIC IOL, THEY A

  Patient problems: Endophthalmitis

  MAUDE report 25453246 ↗
• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER THAT PPG ST MARY¿S PORTSMOUTH HAS IDENTIFIED A BACTERIAL INFECTION AFFECTING THEIR OPHTHALMOLOGY PATIENTS. AT THIS TIME, IT IS NOT KNOWN WHETHER THE INFECTION IS RELATED TO THE COMPANY¿S LENSES, BUT THE HOSPITAL HAS NOTIFIED ALL OPHTHALMOLOGY SUPPLIERS AS A PRECAUTION. THROUGH FOLLOW UP WE LEARNED THAT A TOTAL OF FIVE PATIENTS WERE AFFECTED BY SUSPECTED ENDOPHTHALMITIS, SPECIFIC DATES BELOW. ALL FIVE PATIENTS WERE TREATED WITH INTRAVITREAL ANTIBIOTICS, ORAL AND TOPICAL ANTIBIOTICS AND ONE PATIENT ALSO REQUIRED TOPICAL STEROIDS. AS WE CANNOT RULE OUT ANY PRODUCTS, ALL SUSPECT PRODUCTS ARE REPORTED WITH ALL INTERVENTIONS PROVIDED. AT PRESENT THERE ARE NO LONG-TERM EFFECTS ON THE PATIENT'S VISION AND NO FURTHER INTERVENTIONS HAVE BEEN REQUIRED. ON (B)(6) 2026: INTRAVITREAL ANTIBIOTICS, ORAL AND TOPICAL ANTIBIOTICS ONLY. ON (B)(6) 2026: INTRAVITREAL ANTIBIOTICS, ORAL AND TOPICAL ANTIBIOTICS ONLY. ON (B)(6) 2026: INTRAVITREAL ANTIBIOTICS, ORAL AND TOPICAL ANTIBIOTICS ONLY. ON (B)(6) 2026: INTRAVITREAL ANTIBIOTICS, STEROIDS AND TOPICAL ANTIBIOTICS ONLY. ON (B)(6) 2026: INTRAVITREAL ANTIBIOTICS, ORAL AND TOPICAL ANTIBIOTICS ONLY. NO FURTHER INFORMATION HAS

  Patient problems: Endophthalmitis

  MAUDE report 25453181 ↗
• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER THAT (B)(6) HAS IDENTIFIED A BACTERIAL INFECTION AFFECTING THEIR OPHTHALMOLOGY PATIENTS. AT THIS TIME, IT IS NOT KNOWN WHETHER THE INFECTION IS RELATED TO THE COMPANY¿S LENSES, BUT THE HOSPITAL HAS NOTIFIED ALL OPHTHALMOLOGY SUPPLIERS AS A PRECAUTION. THROUGH FOLLOW UP WE LEARNED THAT A TOTAL OF FIVE PATIENTS WERE AFFECTED BY SUSPECTED ENDOPHTHALMITIS, SPECIFIC DATES BELOW. ALL FIVE PATIENTS WERE TREATED WITH INTRAVITREAL ANTIBIOTICS, ORAL AND TOPICAL ANTIBIOTICS AND ONE PATIENT ALSO REQUIRED TOPICAL STEROIDS. AS WE CANNOT RULE OUT ANY PRODUCTS, ALL SUSPECT PRODUCTS ARE REPORTED WITH ALL INTERVENTIONS PROVIDED. AT PRESENT THERE ARE NO LONG-TERM EFFECTS ON THE PATIENT'S VISION AND NO FURTHER INTERVENTIONS HAVE BEEN REQUIRED. THROUGH FURTHER FOLLOW UP WE LEARNED THE SUSPECT PRODUCTS FOR THESE COMPLAINTS ARE GCB INTRAOCULAR LENS (IOL), LAMINAR FLOW PHACO TIPS, PACHO HANDPIECE, TUBING SETS AND (B)(6) WERE USED ON EACH PATIENT. THERE WAS NO DIFFERENTIATION AS TO WHICH PATIENT HAD WHICH SPECIFIC DEVICE AND AS SUCH, ALL FILES WILL REMAIN CODED WITH TOPICAL STEROIDS. AS WE CANNOT IDENTIFY THE PHACO HANDPIECE USED IN CONJUNCTION WITH THIS SPECIFIC IOL, THEY A

  Patient problems: Endophthalmitis

  MAUDE report 25453171 ↗
• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER HAD IDENTIFIED A BACTERIAL INFECTION AFFECTING THEIR OPHTHALMOLOGY PATIENTS. AT THE TIME IT WAS NOT KNOWN WHETHER THE INFECTION WAS RELATED TO J&J PRODUCTS, BUT THE HOSPITAL NOTIFIED ALL OPHTHALMOLOGY SUPPLIERS AS A PRECAUTION. THROUGH FOLLOW UP WE LEARNED THAT A TOTAL OF FIVE PATIENTS WERE AFFECTED BY SUSPECTED ENDOPHTHALMITIS, SPECIFIC DATES BELOW. ALL FIVE PATIENTS WERE TREATED WITH INTRAVITREAL ANTIBIOTICS, ORAL AND TOPICAL ANTIBIOTICS AND ONE PATIENT ALSO REQUIRED TOPICAL STEROIDS. AS WE CANNOT RULE OUT ANY PRODUCTS, ALL SUSPECT PRODUCTS ARE REPORTED WITH ALL INTERVENTIONS PROVIDED. AT PRESENT THERE ARE NO LONG-TERM EFFECTS ON THE PATIENT'S VISION AND NO FURTHER INTERVENTIONS HAVE BEEN REQUIRED. (B)(6) 2026: INTRAVITREAL ANTIBIOTICS, ORAL AND TOPICAL ANTIBIOTICS ONLY. (B)(6) 2026: INTRAVITREAL ANTIBIOTICS, ORAL AND TOPICAL ANTIBIOTICS ONLY. (B)(6) 2026: INTRAVITREAL ANTIBIOTICS, ORAL AND TOPICAL ANTIBIOTICS ONLY. (B)(6) 2026: INTRAVITREAL ANTIBIOTICS, STEROIDS AND TOPICAL ANTIBIOTICS ONLY. (B)(6) 2026: INTRAVITREAL ANTIBIOTICS, ORAL AND TOPICAL ANTIBIOTICS ONLY. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Endophthalmitis

  MAUDE report 25453086 ↗
• MalfunctionJun 5, 2025Contamination; Contamination

  IT WAS REPORTED THAT DURING PROCEDURE WHEN USING THE PHACO TUBING PACK AND THE HANDPIECE, A FOREIGN MATERIAL CAME OUT FROM THE TIP. IT WAS ASPIRATED FROM THE PATIENT'S EYE AND THE PHACO TUBING PACK WAS REPLACED. NO INFLAMMATION WAS OBSERVED IN THE PATIENTS EYE AND THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED. NOTE: A SEPARATE REPORT WILL BE SUBMITTED FOR THE HANDPIECE AND THE HANDPIECE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22151009 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT HAD A CORNEAL BURN DURING SCULPT AND REQUIRED 4 SUTURES TO CLOSE THE WOUND. THERE WAS NO POST-OPERATIVE COMPLICATION AND NO PERMANENT DAMAGE TO CORNEA/SCLERA. THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS AGAINST THE OPO73. SEPARATE REPORTS WILL BE SUBMITTED AGAINST THE VERITAS CONSOLE, ELLIPS HANDPIECE AND 21G TIP.

  Patient problems: Eye Burn

  MAUDE report 21939557 ↗
• InjuryMar 20, 2025Mechanical Problem; Use of Device Problem; Mechanical Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, USING THE WHITESTAR SIGNATURE PRO SYSTEM, A CHALLENGING CASE INVOLVING A PATIENT WITH GLAUCOMA WAS ENCOUNTERED. THE SURGEON FACED DIFFICULTIES DUE TO THE PATIENT'S PUPIL NOT DILATING AND A SHALLOW CHAMBER. DESPITE CONSIDERING STOPPING THE PROCEDURE, HE DECIDED TO CONTINUE, WHICH LED TO COMPLICATIONS WITH A FLOPPY IRIS THAT PROLAPSED THROUGH THE CORNEAL INCISION. THE INCISION WAS ENLARGED AND SUTURES WERE REQUIRED. AN UNPLANNED VITRECTOMY WAS PERFORMED, AND THE VITRECTOMY CUTTER FUNCTIONED AS EXPECTED. HOWEVER, THE SURGEON WAS UNABLE TO IMPLANT THE INTRAOCULAR LENS (IOL) AND OPTED TO RECALL THE PATIENT FOR A FUTURE PROCEDURE USING A THREE-PIECE IOL.

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

  MAUDE report 21657894 ↗
• 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 ↗
• InjuryMar 4, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE SURGEON MENTIONED THERE WERE BUBBLES VISIBLE DURING THE PROCEDURE. HE EXPERIENCED A VITRECTOMY AND ADDED THAT HE THOUGHT THE BUBBLES WERE THE CAUSE. THERE WAS A 10 MINUTE DELAY IN THE PROCEDURE. WE LEARNED THROUGH FOLLOW UP THE BUBBLES WERE SEEN DURING THE PROCEDURE, DURING CHOP, THE QUADRANT AND IRRIGATION/ASPIRATION PHASE. IT IS UNKNOWN HOW THE PATIENT IS NOW. THROUGH FURTHER FOLLOW UP IT WAS CONFIRMED THE SUSPECT DEVICE WAS OPO73, LOT NUMBER NOT AVAILABLE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21520034 ↗
• 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 ↗
• InjuryJul 3, 2024Failure to Prime; Suction Problem; Failure to Prime; Suction Problem

  IT WAS REPORTED THAT WHEN USING THE OPO73 UNIT, A PRIME ISSUE (ERROR 501) OCCURRED SEVERAL TIMES. THE PACK WAS RESEATED SEVERAL TIMES AND PRIMING WAS PERFORMED. THERE WAS NO SUCTION AND WHEN IT SUDDENLY STARTED, IT DAMAGED THE PATIENT'S CAPSULE. THE PHYSICIAN USED A A-VIT DEVICE INTENDED TO TREAT THE CAPSULE RUPTURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 19666729 ↗
• 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 ↗

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