COMPACT INTUITIV SCP680300Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 05050474573628), received between Nov 1, 2016 and Sep 23, 2026 — classified as 38 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Unexpected Shutdown

  It was reported that the system shut down towards the end of the case, during Irrigation/Aspiration (IA). No patient injury was reported. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50871809 ↗
• MalfunctionJun 9, 2026Computer Software Problem

  IT WAS REPORTED BY THE CUSTOMER THAT, DURING CATARACT SURGERY, THE COMPACT INTUTIV SYSTEM FAILED TO ENTER WORKING MODE, RESULTING IN THE SUSPENSION OF THE PROCEDURE. THE DEVICE MALFUNCTION CAUSED ADDITIONAL PHYSICAL AND PSYCHOLOGICAL BURDEN TO THE PATIENT, INCLUDING EMOTIONAL TENSION. THE ISSUE WAS DISCOVERED DURING THE OPERATION, AND THE PATIENT WAS SUBSEQUENTLY COMFORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25452317 ↗
• MalfunctionAug 8, 2024Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED, THAT THE COMPACT INTUITIVE SYSTEM SHUTS DOWN ITSELF, DURING SURGERY. SYSTEM COULD NOT START UP. THERE WAS NO PATIENT INJURY. HOSPITAL HAS ANOTHER MACHINE TO PERFORM SURGERY. NO FURTHER INFORMATION IS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19945605 ↗
• MalfunctionJun 11, 2024Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT AN ERROR DURING PHACOEMULSIFICATION PROCEDURE OCCURRED. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19515277 ↗
• InjurySep 11, 2023Energy Output Problem; Infusion or Flow Problem; Adverse Event Without Identified Device or Use Problem; Energy Output Problem; Infusion or Flow Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS CORNEAL BURN (THERMAL INJURY) ON PATIENT'S LEFT EYE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Eye Burn

  MAUDE report 17722036 ↗
• InjuryApr 6, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WHEN LOWERING THE BOTTLE TO 15 IN POLE HEIGHT AS HE WAS PHASING, STOPPED THE FLOW OF WATER AND CAUSED A CORNEA BURN AT THE WOUND ON UNKNOWN PATIENT'S EYE. THE CONTINUE IRRIGATION WAS ON THOUGH AND NO WATER WAS FLOWING WHEN THE SURGEON NOTICED. THE SURGEON TURNED OFF CONTINUOUS IRRIGATION AND TURNED IT BACK ON BUT NO IRRIGATION OR TURNING OF THE MECHANISMS AT THE PHACO TUBING MANIFOLD. IT WAS STATED HE HAD TO END CASE AND REPRIME AND TUNE. AFTER THAT IT STARTED WORKING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Eye Burn

  MAUDE report 16698047 ↗
• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Therapeutic or Diagnostic Output Failure; Adverse Event Without Identified Device or Use Problem; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THERE WAS A CAPSULE RUPTURE AND A VITRECTOMY WAS REQUIRED. THE SURGEON TRIED TO USE A-VIT (ANTERIOR VITRECTOR) BUT COULDN T USE IT BECAUSE OF ERROR 340 (VITRECTOMY PRESSURE LEAK) WHICH OCCURRED IN VITRECTOMY PRIME MODE. NO OTHER PATIENT INJURY OR SURGICAL INTERVENTION WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT THE PROCEDURE WAS COMPLETED WITHOUT USING THE VITRECTOMY CUTTER. DAY 1 POSTOPERATIVELY, SURGEON CHECKED THE PATIENT'S EYE AND CONFIRMED THERE WAS NO ISSUE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 15577340 ↗
• InjuryAug 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DOCTOR NOTICED CORNEAL WOUND BURN IN THE END OF SURGERY DESPITE MINIMAL PHACO POWER USE. PATIENT STATUS WAS NOTED AS PERMANENTLY IMPAIRED. SUTURES WERE REQUIRED AND THERE WAS A 40 MIN DELAY IN THE PROCEDURE DUE TO THE DIFFICULTY IN SUTURING THE WOUND. IT WAS ALSO REPORTED MEDICATION WAS PRESCRIBED THAT INCLUDED LUBRICANTS AND VITAMIN C TO AID WOUND HEALING. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Eye Burn

  MAUDE report 15142902 ↗
• InjuryAug 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DOCTOR NOTICED CORNEAL WOUND BURN IN THE END OF SURGERY DESPITE MINIMAL PHACO POWER USE. PATIENT STATUS WAS NOTED AS PERMANENTLY IMPAIRED. SUTURES WERE REQUIRED AND THERE WAS A 40 MIN DELAYIN THE PROCEDURE DUE TO THE DIFFICULTY IN SUTURING THE WOUND. IT WAS ALSO REPORTED MEDICATION WAS PRESCRIBED THAT INCLUDED LUBRICANTS AND VITAMIN C TO AID WOUND HEALING. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Eye Burn

  MAUDE report 15142812 ↗
• InjuryAug 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DOCTOR NOTICED CORNEAL WOUND BURN IN THE END OF SURGERY DESPITE MINIMAL PHACO POWER USE. PATIENT STATUS WAS NOTED AS PERMANENTLY IMPAIRED. SUTURES WERE REQUIRED AND THERE WAS A 40 MIN DELAYING THE PROCEDURE DUE TO THE DIFFICULTY IN SUTURING THE WOUND. IT WAS ALSO REPORTED MEDICATION WAS PRESCRIBED THAT INCLUDED LUBRICANTS AND VITAMIN C TO AID WOUND HEALING. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Eye Burn

  MAUDE report 15142046 ↗
• InjuryJun 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ANTERIOR VITRECTOMY WAS NECESSARY DUE TO RUPTURE OF THE POSTERIOR LENS CAPSULE DURING CATARACT SURGERY USING THE PHACOEMULSIFICATION TECHNIQUE. THIS WAS USING THE COMPACT INTUITIVE SYSTEM AND A VITRECTOMY PROBE WHICH DIDN'T WORK THEREFORE, PATIENT WAS TRANSFERRED TO ANOTHER CLINIC TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE COMPACT INTUITIVE SYSTEM. REFER TO 3012236936-2022-01676 FOR THE REPORT FOR THE VITRECTOMY CUTTER.

  Patient problems: Capsular Bag Tear

  MAUDE report 14795309 ↗
• InjuryJun 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ANTERIOR VITRECTOMY WAS NECESSARY DUE TO RUPTURE OF THE POSTERIOR LENS CAPSULE DURING CATARACT SURGERY USING THE PHACOEMULSIFICATION TECHNIQUE. THIS WAS USING THE COMPACT INTUITIVE SYSTEM AND A VITRECTOMY PROBE WHICH DIDN'T WORK THEREFORE, PATIENT WAS TRANSFERRED TO ANOTHER CLINIC TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE COMPACT INTUITIVE SYSTEM. REFER TO 3012236936-2022-01674 FOR THE REPORT FOR THE VITRECTOMY CUTTER.

  Patient problems: Capsular Bag Tear

  MAUDE report 14795273 ↗
• InjuryNov 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CORNEAL WOUND BURN OCCURRED DURING CATARACT SURGERY. THERE WAS SOME DAMAGE TO THE ENDOTHELIUM (INSIDE OF THE CORNEA). SUTURES WERE REQUIRED AND SURGERY WAS COMPLETED. AT PRESENT VISION IS QUITE POOR. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Eye Burn; Eye Injury; Visual Impairment

  MAUDE report 12849500 ↗
• InjuryAug 13, 2021Suction Problem; Suction Problem

  IT WAS REPORTED THAT DURING CATARACT SURGERY THE SYSTEM SHOWED AN UNBELIEVABLE SURGE. THE DOCTOR WAS UNABLE TO COMPLETE THE PATIENT'S SURGERY. FOLLOW-UP REVEALED THAT TROUBLESHOOTING THE ISSUE BY REPLACING THE TUBING PACK AND THE BALANCED SALT SOLUTION (BSS) DID NOT FIX THE PROBLEM. THEREFORE, THE SURGERY WAS CONVERTED TO EXTRACAPSULAR DURING WHICH A VITRECTOMY WAS PERFORMED AND THE INCISION WAS ENLARGED. THE DOCTOR NOTED DAMAGE TO THE ENDOTHELIUM; HOWEVER, THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS PROVIDED AS CORNEAL ASTIGMATISM A LITTLE BIT ELEVATED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 12321819 ↗
• InjuryMay 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGERY CENTER REPORTED A CATARACT PATIENT EXPERIENCED EDEMA WITH THE USE OF THE EQUIPMENT FOR PHACOEMULSIFICATION. A BRIEF DESCRIPTION OF THE EVENT IS THE PROCEDURE WAS COMPLETED ON (B)(6) 2020 AND AT A POST-OPERATIVE EXAM THE VISUAL ACUITY WAS 20/40. THE SURGEON¿S COMMENTS THAT THE DIRECTIONS FOR USE WERE FOLLOWED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS 1 OF 2 REPORTS. THIS REPORT IS FOR THE COMPACT INTUITIV. A SEPARATE REPORT WILL BE SUBMITTED FOR THE ELLIPS HANDPIECE.

  Patient problems: Corneal Edema; Visual Impairment

  MAUDE report 11854479 ↗
• InjuryMar 31, 2021Computer System Security Problem; Computer System Security Problem

  CAPSULE TEAR WITH INCISION ENLARGEMENT REQUIRING SUTURES WAS REPORTED. A BRIEF DESCRIPTION FROM THE SURGERY CENTER INDICATED THAT DURING A PLANNED VITRECTOMY PROCEDURE ON (B)(6) 2021 ON AN (B)(6) YEAR OLD MALE PATIENT¿S LEFT EYE (OS), A SYSTEM ERROR OCCURRED, RESULTING A CAPSULE TEAR. THE INCISION WAS ENLARGED AND REQUIRED NYLON AND VICRYL SUTURES. THE PROCEDURE WAS COMPLETED, AND AN INTRAOCULAR LENS (IOL) WAS PLACED IN THE SULCUS. THE SURGEON STATED THAT THE PATIENT WAS SUSPECT FOR GLAUCOMA.

  Patient problems: Capsular Bag Tear

  MAUDE report 11599232 ↗
• InjuryMar 10, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A HOSPITAL REPORTED A CATARACT PATIENT EXPERIENCED DAMAGE TO THE ENDOTHELIUM AS A RESULT OF A CORNEAL BURN WITH THE USE OF A COMPACT INTUTIV SYSTEM AND ELLIPS FX PHACO HANDPIECE. ALTHOUGH, THE CATARACT PROCEDURE WAS COMPLETED AND THE LENS WAS IMPLANTED IN THE CAPSULAR BAG, IT WAS REPORTED SURGICAL INTERVENTION WAS REQUIRED. IN ADDITION, THE INJURY TO THE DAMAGE ENDOTHELIUM MAY HAVE CAUSED KERATITIS. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR THE COMPACT INTUTIV SYSTEM. A SEPARATE REPORT WILL BE SUBMITTED FOR THE ELLIPS FX PHACO HANDPIECE.

  Patient problems: Eye Burn; Keratitis

  MAUDE report 11455754 ↗
• InjuryMar 10, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A HOSPITAL REPORTED A CATARACT PATIENT EXPERIENCED DAMAGE TO THE ENDOTHELIUM AS A RESULT OF A CORNEAL BURN WITH THE USE OF A COMPACT INTUTIV SYSTEM AND ELLIPS FX PHACO HANDPIECE. ALTHOUGH, THE CATARACT PROCEDURE WAS COMPLETED AND THE LENS WAS IMPLANTED IN THE CAPSULAR BAG, IT WAS REPORTED SURGICAL INTERVENTION WAS REQUIRED. IN ADDITION, THE INJURY TO THE DAMAGE ENDOTHELIUM MAY HAVE CAUSED KERATITIS. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR THE COMPACT INTUTIV SYSTEM. A SEPARATE REPORT WILL BE SUBMITTED FOR THE ELLIPS FX PHACO HANDPIECE.

  Patient problems: Eye Burn; Keratitis

  MAUDE report 11455478 ↗
• InjuryNov 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A CAPSULE TEAR OCCURRED WHILE THE SURGEON WAS PERFORMING EPI NUCLEUS AND, DUE TO THE SUDDEN STOP OF THE SYSTEM, A POSTERIOR CAPSULAR RUPTURE (PCR) OCCURRED. THE SYSTEM WAS RESTARTED, AND THE SURGEON PROCEEDED WITH THE SURGERY. THE PCR ENLARGED AND THE SURGEON DECIDED TO SWITCH FROM A MULTIFOCAL IOL TO A SENSAR 3-PIECE LENS. THE PATIENT WAS APHAKIC AT THE END OF THE SURGERY FOR 1 HOUR 30 MINUTES. AN UNPLANNED VITRECTOMY WAS PERFORMED. THE PATIENT'S OUTCOME IS UNKNOWN.

  Patient problems: Capsular Bag Tear; Vitrectomy

  MAUDE report 10782455 ↗
• InjurySep 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SURGERY CENTER REPORTED A POSSIBLE MILD CORNEAL BURN DURING A PHACO SESSION. NO FURTHER INFORMATION WAS PROVIDED REGARDING PATIENT OUTCOME. THE SITE PERFORMED THEIR OWN INVESTIGATION WHICH REVEALED THAT THE PHACO SYSTEM SETTINGS HAD BEEN INADVERTENTLY CHANGED FROM THEIR NORMAL 33% AT 6MS ON 12MS OFF TO A SETTING WITH 60% ON TIME.

  Patient problems: Eye Burn

  MAUDE report 10527888 ↗
• InjuryNov 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGEON REPORTED THAT DURING CATARACT SURGERY ON (B)(6) 2019, ONCE HE APPLIED THE PHACO TIP TO THE PATIENT'S LEFT EYE HE IMMEDIATELY SAW A WHITE PLUME APPEAR AND REMOVED THE TIP. THE PATIENT REQUIRED A SINGLE FIGURE 8 SUTURE FOLLOWING THE CORNEAL BURN. THE SURGEON REPORTED THAT THE EVENT MAY HAVE BEEN DUE TO PHYSICIAN TECHNIQUE, BUT HE COULD NOT CONFIRM THIS. ON (B)(6) 2019, A SECONDARY PROCEDURE WAS PERFORMED ON THE LEFT EYE BY APPLYING AN ADDITIONAL SINGLE FIGURE 8 SUTURE OVER THE INCISION. THE PATIENT IS STILL HEALING. THIS REPORT IS FOR THE COMPACT INTUITIV PHACO SYSTEM. AN ADDITIONAL REPORT IS BEING SUBMITTED FOR THE 21 GAUGE LAMINAR PHACO TIP.

  Patient problems: Eye Burn

  MAUDE report 9337408 ↗
• InjuryMar 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A CATARACT EXTRACTION PROCEDURE, A CORNEAL BURN OCCURRED IN THE PATIENT¿S OPERATIVE EYE. A SUTURE WAS REQUIRED TO CLOSE THE INCISION. THE PROCEDURE WAS COMPLETED. IT WAS REPORTED THE CORNEAL BURN EVENT WAS A RESULT OF A NEW OPERATING ROOM TECHNICIAN SELECTING THE DEFAULT SETTINGS INSTEAD OF SELECTING THE SURGEON¿S PROGRAM SETTINGS.

  Patient problems: Eye Burn

  MAUDE report 8425545 ↗
• InjuryMar 15, 2019Mechanical Problem; Failure to Cut; Mechanical Problem; Failure to Cut

  DURING A CATARACT EXTRACTION PROCEDURE, THE SURGERY CENTER REPORTED A CAPSULAR TEAR IN THE PATIENT¿S LEFT EYE REQUIRING AN UNPLANNED VITRECTOMY PROCEDURE WHEN USING THE COMPACT INTUITIV CONSOLE. THE SURGERY CENTER INDICATED DURING AN UNPLANNED VITRECTOMY PROCEDURE, A 340-ERROR-PNEUMATIC VITRECTOMY PRIME FAILURE DISPLAYED DURING THE PRIMING OF THE VITRECTOMY CUTTER. ALTHOUGH MULTIPLE VITRECTOMY HANDPIECES WERE REPLACED, AND THE CONSOLE WAS REBOOTED, THE PROBLEM PERSISTED.

  Patient problems: Capsular Bag Tear; Vitrectomy

  MAUDE report 8425438 ↗
• InjuryFeb 19, 2019Mechanical Problem; Failure to Cut; Mechanical Problem; Failure to Cut

  A SURGERY CENTER REPORTED AN UNPLANNED VITRECTOMY AND ABORTED PROCEDURE WITH THE COMPACT INTUITIV CONSOLE. A DESCRIPTION FROM THE SURGERY CENTER INDICATED DURING AN UNPLANNED VITRECTOMY PROCEDURE, A 340-ERROR-PNEUMATIC VITRECTOMY PRIME FAILURE DISPLAYED DURING THE PRIMING OF THE VITRECTOMY CUTTER. THE SURGERY CENTER WAS NOT ABLE TO COMPLETE PROCEDURE. ALTHOUGH, ATTEMPTS WERE MADE FOR ADDITIONAL INFORMATION, THE SURGERY CENTER WAS NOT WILLING TO PROVIDE ADDITIONAL INFORMATION.

  Patient problems: Vitrectomy

  MAUDE report 8352033 ↗
• MalfunctionNov 19, 2018Obstruction of Flow; Obstruction of Flow

  DURING A CATARACT PROCEDURE, THE TIP BECAME OCCLUDED/CLOGGED USING A REUSABLE OPOF3020R- LAMINAR FLOW PHACO TIP. A BRIEF DESCRIPTION FROM THE SURGERY CENTER INDICATED THERE WAS A CLOGGED TIP DURING THE PROCEDURE, HENCE THE PROCEDURE WAS ABORTED AND NOT COMPLETED. THE SURGERY CENTER REPORTED 501 ERROR HAS BEEN OCCURRING FREQUENTLY AND IT IS UNKNOWN IF THE 501-ERROR OCCURRED DURING THE PROCEDURE. ALTHOUGH, THERE WAS AN ATTEMPT TO RESTART THE PHACOEMULSIFICATION UNIT, REPLACE THE PHACO HANDPIECE, AND REPLACE THE TUBING PACK, THE OCCLUSION WAS STILL PRESENT. THE PATIENT WAS SENT HOME. NO ADDITIONAL INFORMATION WILL BE PROVIDED BY THE SURGERY CENTER. NO PATIENT INJURY WAS REPORTED. THIS REPORT IS FOR THE PHACOFRAGMENTATION UNIT. A SEPARATE REPORT WILL BE SUBMITTED FOR THE PHACO TIP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8086817 ↗