ELLIPS FX PHACO HANDPIECE 690880Recalls & reported problems

Summary

The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 05050474537132), received between Sep 13, 2016 and Sep 11, 2026 — classified as 70 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (16 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 81 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  The customer reported a possible incision burn caused by the phaco. The physician expressed surprise and noted that he had not encountered this issue since his school years. No patient impact or additional device details were provided.Additional information was received, stating that the surgery date was that the medical doctor did not notice anything different during his Phaco but noticed a "burn" at the main incision. It was also reported that unplanned medical or surgical intervention occurred, with 2x sutures needed, and the sutures were required for a leaky incision due to burn.NOTE: This is report 1 of 4.

  Patient problems: Eye Burn

  MAUDE report 50734766 ↗
• InjuryJul 10, 2026Overheating of Device

  IT WAS REPORTED THAT THE HANDPIECE OVERHEATED, CAUSING A CORNEAL BURN THAT REQUIRED 2 STITCHES. COMPLICATIONS AROSE, WITH A RISK OF LONG-TERM EFFECTS. NO FURTHER INFORMATION WAS PROVIDED. SEPARATE REPORTS WILL BE SUBMITTED FOR THE PHACO SYSTEM AND PHACO TUBING PACK.

  Patient problems: Eye Burn

  MAUDE report 25782179 ↗
• 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. 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 DK9000 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 SP

  Patient problems: Endophthalmitis

  MAUDE report 25453258 ↗
• 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. 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 DK9000 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 SP

  Patient problems: Endophthalmitis

  MAUDE report 25453230 ↗
• 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. 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 DK9000 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 SP

  Patient problems: Endophthalmitis

  MAUDE report 25453179 ↗
• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD CATARACT PROCEDURE IN THE LEFT EYE AND A CORNEAL BURN OCCURRED DURING THE SCULPT PART OF THE PROCEDURE. THE INCISION SIZE WAS 2.4 MM. SEVERAL JNJ PRODUCTS WERE USED: VERITAS CONSOLE, PHACO HANDPIECE, PHACO TIP SLEEVE AND VERITAS VRT-AI PACK. SURGEON USED ALCON BAG BALANCED SALT SOLUTION. THERE WERE NO SYSTEM ERRORS BUT IT WAS REPORTED THAT THERE WERE EXCESSIVE BUBBLES IN THE CHAMBER DURING SCULPTING. NO PRODUCT IS BEING RETURNED. THIS REPORT IS FOR THE ELLIPS FX PHACO HANDPIECE PRODUCT.

  Patient problems: Eye Burn

  MAUDE report 25291122 ↗
• 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 FOR THE HANDPIECE. A SEPARATE REPORT WILL BE FILED AGAINST WHITESTAR, TIP AND TUBING.

  Patient problems: Eye Burn

  MAUDE report 22821424 ↗
• InjuryJul 23, 2025Infusion or Flow Problem; Infusion or Flow Problem

  THE CUSTOMER REPORTED A CORNEAL BURN THAT NECESSITATED THREE SUTURES, ATTRIBUTING THE INJURY TO AN ISSUE WITH THE FLOW OF IRRIGATION DURING THE USE OF THE HANDPIECE. THE CUSTOMER ALSO INDICATED THAT NO ADDITIONAL PATIENT INTERVENTION OR INJURY WAS ASSOCIATED WITH THE INCIDENT. THIS REPORT IS FOR THE ELLIPS FX PHACO HANDPIECE. SEPARATE REPORTS WILL BE SUBMITTED FOR OTHER PRODUCTS USED DURING THE EVENT.

  Patient problems: Eye Burn

  MAUDE report 22578614 ↗
• InjuryMay 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, PATIENT HAD SURGERY AND THERE WAS A CORNEAL BURN ON PATIENT'S RIGHT EYE WHICH REQUIRED STICHES ON (B)(6) 2025. PATIENT IS DOING GOOD POST-OPERATIVELY WITHOUT ANY COMPLICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Eye Burn

  MAUDE report 21997908 ↗
• InjuryApr 17, 2025Contamination; Contamination

  IT WAS REPORTED THAT PATIENT SHOWED SIGNS OF A POST-OPERATIVE INFECTION TOXIC ANTERIOR SEGMENT SYNDROME (TASS) THE DAY AFTER SURGERY ON RIGHT EYE. A SMALL DEBRIS WAS DETECTED DURING SURGERY WHEN THE PHACO TIP WAS IN THE EYE UNDER THE BLUE SLEEVE. THE DOCTOR OBSERVED THE DEBRIS AND DECIDED TO CHANGE THE HANDPIECE AND PHACO TIP TO CONTINUE WITH THE PROCEDURE. AS A RESULT THERE IS TEMPORARY BLURRY VISION. BEST CORRECTED VISUAL ACUITY PRE-OPERATIVE: 6/18 BEST CORRECTED VISUAL ACUITY POST-OPERATIVE: 24 HOURS 6/15, 48 HOURS 6/30.

  Patient problems: Blurred Vision; No Clinical Signs, Symptoms or Conditions; Toxic Anterior Segment Syndrome (TASS); Visual Impairment

  MAUDE report 21860744 ↗
• InjuryDec 2, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE SYSTEM PRIMED AND TUNED CORRECTLY PRIOR TO THE CASE BUT DURING PHACO, THE MACHINE WAS GIVING THE OCCLUSION SOUND (DINGING) ALTHOUGH THE MACHINE WAS NOT OCCLUDED. AT THAT POINT, THE DOCTOR APPLIED MORE PHACO POWER THAN NEEDED. HE THOUGHT THERE MUST HAVE BEEN SOME LENS MATERIAL OCCLUDING THE TIP (THAT WAS THE SIGNAL FOR HIM TO DEPRESS THE FOOT PEDAL TO APPLY POWER). AS A RESULT OF THIS, A WOUND BURN OCCURRED ON THE PATIENT'S RIGHT EYE. DOCTOR TRIED FLUSHING THE HANDPIECE WITH SALINE, ASSUMING IT WAS OCCLUDED SOMEWHERE, BUT IT FLUSHED NORMALLY. AFTER THIS, THE DOCTOR TRIED USING THE HANDPIECE AGAIN AND HAD THE SAME ISSUE. THEY RERAN THE PRIME AND TUNE WHICH GAVE AN ERROR FOR "LOOSE HANDPIECE." THEY THEN GOT ANOTHER HANDPIECE WHICH PRIMED AND TUNED CORRECTLY AND FINISHED THE PHACO PORTION OF THE PROCEDURE NORMALLY. DOCTOR COULD NOT GET THE MAIN INCISION TO SEAL WITH AGGRESSIVE HYDRATION (DUE TO THE WOUND BURN), SO ULTIMATELY PLACED A SUTURE. THE PATIENT HAS DONE VERY WELL. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THIS REPORT IS AGAINST THE HANDPIECE. A SEPARATE REPORT WILL BE FILED AGAINST THE TIP.

  Patient problems: Eye Burn

  MAUDE report 20828236 ↗
• InjurySep 24, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE HANDPIECE WAS IN THE WOUND FOR A WHILE AND IT STARTED TO HEAT UP. THE DOCTOR DECIDED TO WITHDRAW IT AND REPLACED THE HANDPIECE WITH A DIFFERENT ONE. ONE STITCH WAS ADMINISTERED AND THE OPERATION WAS COMPLETED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 20291976 ↗
• InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A DIFFICULT CATARACT OPERATION, WITH A VERY HARD CORE, WITH A PHACO VERITAS, THERE WAS A CASE OF CORNEAL BURN. WE'VE LEARNED THROUGH FOLLOW UP THAT 3 SUTURES WERE REQUIRED AS HYDRO-SUTURING WAS NOT POSSIBLE DUE TO CORNEAL DECOMPENSATION. THE PATIENT RECOVERED AFTER 15 DAYS. THE DOCTOR HAS ALWAYS BEEN SATISFIED WITH VÉRITAS, AND ACKNOWLEDGES THAT THIS CATARACT WAS THE FIRST OF ITS KIND HE HAD OPERATED ON. HE DOES NOT BELIEVE THAT THE JNJ DEVICE WAS AT FAULT AND ASSUMES RESPONSIBILITY. SETTING CHANGES WERE DISCUSSED AND THE FOLLOWING PROCEDURE WENT WELL. NO FURTHER DETAIL WAS PROVIDED.

  Patient problems: Burn(s); Corneal Decompensation; Eye Burn

  MAUDE report 19214510 ↗
• InjuryMar 27, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED A CORNEAL BURN DURING TREATMENT WHILE USING THE WHITESTAR SIGNATURE PRO SYSTEM HANDPIECE. NO FURTHER DETAILS HAVE BEEN SHARED.

  Patient problems: Eye Burn

  MAUDE report 18986667 ↗
• InjuryDec 1, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING THE CATARACT OPERATION, THE SURGEON INITIATED PHACOEMULSIFICATION AND THE TIP OF THE HANDPIECE ABNORMALLY HEATED AND CAUSED A CORNEAL BURN AND AN ABNORMAL ENLARGEMENT OF THE INCISION. THIS OCCURRED DURING THE FIRST GROOVE PHASE. THE PHACO TEST FUNCTIONED NORMALLY, AND THE HANDPIECE WAS INITIALLY AT A COOL TEMPERATURE. THE SURGERY WAS STOPPED TO REPLACE THE TIP AND HANDPIECE. THE PATIENT'S CURRENT CONDITION INCLUDES TWO SUTURES PLACED FOLLOWING THE INCISION BURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Burn; Unspecified Eye / Vision Problem

  MAUDE report 18244022 ↗
• InjuryAug 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON HAD COMPLETED ONE CASE SUCCESSFULLY AND CONTINUED FOR A 2ND PATIENT. AFTER THE SCULPT PHASE IN THIS CASE THE SURGEON CARRIED OUT A VITRECTOMY. THE MACHINE AND HANDPIECE APPEARED TO FUNCTION NORMALLY AND NO COMMENTS WERE MADE EITHER RELATING TO THE VERITAS OR ITS HANDPIECE. THERE WAS A 10 MINUTE DELAY IN THE PROCEDURE. WE LEARNED THROUGH FOLLOW UP, THAT THE SURGEON BLAMES THE MACHINE AND HANDPIECE FOR THE EVENT. IT IS UNKNOWN IF THE PATIENT HAD A PREEXISTING CONDITION. THE VITRECTOMY WAS REQUIRED BECAUSE THE PATIENT'S NATURAL LENS WAS PUSHED THROUGH THE BACK OF THE CAPSULE. IT IS UNKNOWN IF THE PATIENT WAS PERMANENTLY IMPAIRED. THE PATIENT WAS SENT TO A NEARBY HOSPITAL AND IT IS UNKNOWN IF AN OVERNIGHT STAY WAS NEEDED. NO FURTHER SURGICAL OR MEDICAL INTERVENTIONS APART FROM THE VITRECTOMY WERE REPORTED AND THE PATIENTS OUTCOME IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED. A SEPARATE REPORT IS BEING SUBMITTED FOR THE OTHER SUSPECTED PRODUCT.

  Patient problems: Capsular Bag Tear

  MAUDE report 17502678 ↗
• InjuryApr 6, 2023Use of Device Problem; Suction Problem; Use of Device Problem; Suction Problem

  IT WAS REPORTED THAT CUSTOMER FOUND NUCLEAR FRAGMENTS REMAINED IN THE ANTERIOR CHAMBER DURING THE POST EXAMS. SURGEON PERCEIVED THAT THE VACUUM PERFORMANCE DURING IRRIGATION ASPIRATION AND PHACO MODE WAS BIT LOW. THE ISSUE HAD OCCURRED IN THREE PROCEDURES SINCE AFTER THE MACHINE WAS CHECKED ON (B)(6) 2023. REPORTEDLY TRANSCONJUNCTIVAL SINGLE PLANE SCLERACORNEAL INCISION METHOD WAS USED WITH 2.75 MM INCISION SIZE. THERE WAS NO INCISION WIDENED. SURGEON WILL PERFORM SECONDARY SURGERY TO REMOVE FRAGMENTS WITH IRRIGATION ASPIRATION AND IS PLANNED FOR END OF (B)(6) 2023. PATIENT WAS PRESCRIBED WITH MEDICATION (LEVOFLOXACIN, SANBETASON). THE PATIENT OUTCOME WAS REPORTED AS GOOD VISUAL ACUITY WITH NO PROBLEMS. THE PACK WAS REUSED FOR THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT SECONDARY SURGERY WAS PERFORMED ON (B)(6) 2023 WHERE THERE WAS REMOVAL OF RESIDUAL NUCLEAR FRAGMENTS PERFORMED BY USING OPHTHALMIC ANESTHESIA. BI-MANUAL IRRIGATION ASPIRATION WAS USED. SUCTION WHILE SHREDDING NUCLEAR FRAGMENTS AT THE TIP, AND THE NUCLEAR FRAGMENTS WERE PROCESSED WITHOUT PROBLEMS. AFTER THE CATARACT SURGERY ON (B)(6) 2023, GLAUCOMA APPEARED, PROBABLY DUE TO THE EFFECTS OF

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

  MAUDE report 16687757 ↗
• InjuryApr 6, 2023Suction Problem; Human-Device Interface Problem; Suction Problem; Human-Device Interface Problem

  IT WAS REPORTED THAT CUSTOMER FOUND NUCLEAR FRAGMENTS REMAINED IN THE ANTERIOR CHAMBER DURING THE POST EXAMS. SURGEON PERCEIVED THAT THE VACUUM PERFORMANCE DURING IRRIGATION ASPIRATION AND PHACO MODE WAS BIT LOW. THE ISSUE HAD OCCURRED IN THREE PROCEDURES SINCE AFTER THE MACHINE WAS CHECKED ON (B)(6) 2023. REPORTEDLY TRANSCONJUNCTIVAL SINGLE PLANE SCLERCORNEAL INCISION METHOD WAS USED WITH 2.55 MM INCISION SIZE. THERE WAS NO INCISION WIDENED. IRRIGATION, SUCTION, AND REMOVAL WITH IRRIGATION ASPIRATION IS PLANNED FOR END OF MARCH 2023. PATIENT WAS PRESCRIBED WITH MEDICATION (LEVOFLOXACIN, SANBETASON). THE PATIENT OUTCOME WAS REPORTED AS GOOD VISUAL ACUITY WITH NO PROBLEMS. THE PACK WAS REUSED FOR THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT ON (B)(6) 2023 THERE WAS REMOVAL OF RESIDUAL NUCLEAR FRAGMENTS PERFORMED USING OPHTHALMIC ANESTHESIA. SURGEON ASPIRATED BY USING A BI-MANUAL IRRIGATION ASPIRATION (IA) WHILE SHATTERING NUCLEAR FRAGMENTS WITH THE TIP. NUCLEAR FRAGMENTS WERE ASPIRATED WITHOUT PROBLEMS. THERE WAS DESCEMET'S FOLD THAT SEEMED TO BE CAUSED BY AN EFFECT OF THE BI-MANUAL IA OPERATION. AS A RESULT, VISUAL ACUITY DECREASED FROM 0.9 TO 0.6, BUT A

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

  MAUDE report 16687728 ↗
• InjuryDec 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use 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.

  Patient problems: Eye Burn; Intraocular Pressure Increased

  MAUDE report 15988758 ↗
• InjuryOct 27, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE SURGEON SWITCHED TO DENSE MODE AND ONCE IT SWITCHED THEY HEARD A NOISE AND A 374 ERROR (HANDPIECE REMOVED AFTER BEING TUNED) POPPED ON SYSTEM. THEY HAD TO RETUNE THE HANDPIECE DURING SURGERY. SOON AFTER THE SURGEON HAD TO DO A VITRECTOMY. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE HANDPIECE. REFER TO 3012236936-2022-02699 FOR THE VERITAS CONSOLE.

  Patient problems: Insufficient Information

  MAUDE report 15686666 ↗
• InjurySep 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A CATARACT PROCEDURE A CORNEAL BURN OCCURRED IN THE PATIENT'S LEFT EYE. THE BURN REQUIRED SUTURES AND WOUND GLUE. THE DOCTOR WAS ABLE TO COMPLETE THE PROCEDURE AND AT THE TIME OF THIS REPORT THERE IS NO INFORMATION ON THE PATIENT EXPECTED OUTCOME.

  Patient problems: Eye Burn

  MAUDE report 15514123 ↗
• InjuryAug 26, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT PATIENT FELT HEAT WHILE SURGEON WAS SCULPTING A GROOVE IN A NUCLEUS WITH ELLIPS FX HANDPIECE. SURGEON IMMEDIATELY TOOK THE TIP OFF FROM THE PATIENT'S EYE. THE INCISION IN PATIENT'S EYE RECEIVED MILD THERMAL BURN. THE SURGEON CHECKED THE HANDPIECE AND CONFIRMED THE HANDPIECE HAD BECOME HOT. SURGEON REPLACED WITH THE PHACO MACHINE AND EQUIPMENT OF ANOTHER COMPANY¿S PRODUCT, AND THE SURGERY WAS SUCCESSFULLY COMPLETED. SURGEON USED THE US POWER 85% SETTING AND FULLY APPLIED THE FOOT PEDAL WHEN THE ISSUE OCCURRED. OPO73 FUSION DUAL PUMP PACK WAS USED FOR MULTIPLE PROCEDURES PRIOR TO THE INCIDENT. OPO73 WAS DISCARDED BY THE CUSTOMER AND NO SAMPLE WAS GOING TO BE RETURNED FOR INVESTIGATION. THERE WAS NO VITRECTOMY PERFORMED, NO MEDICATION FOR THERMAL BURN TREATMENT WAS REPORTEDLY PROVIDED. SUTURES WERE USED TO PREVENT FURTHER PATIENT INJURY. THE INCISION SIZE WAS REPORTED AS 2.4MM. THIS REPORT IS FOR ELLIPS FX PHACO HANDPIECE SYSTEM. A SEPARATE MDR REPORT IS BEING SUBMITTED FOR OPO73 FUSION DUAL PUMP PACK. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Burn(s)

  MAUDE report 15303348 ↗
• InjuryMar 28, 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 13925941 ↗
• MalfunctionMar 11, 2022Contamination; Contamination

  IT WAS REPORTED THAT A FOREIGN MATTER, WHICH LOOKED LIKE A PIECE OF METAL 2-3MM LONG, ENTERED INTO PATIENT¿S EYE AT THE BEGINNING OF PHACO PROCEDURE DURING SURGERY. THE FOREIGN MATTER WAS IMMEDIATELY REMOVED FROM PATIENT¿S EYE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13728535 ↗
• InjuryMar 2, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT DURING CATARACT SURGERY, THERE WAS CORNEAL WOUND BURN EXPERIENCED THAT REQUIRED 5 STITCHES. SURGEON STATED THAT THERE WAS CLOG BUT CONTINUED TO PHACO. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Eye Burn

  MAUDE report 13653047 ↗