COMPACT INTUITIVRecalls & reported problems across all models

We found 2 models of COMPACT INTUITIV by Johnson & Johnson Surgical Vision, Inc. in the FDA's device registry (GUDID). Together they are named in 122 adverse event reports in the FDA's MAUDE database, received between Nov 1, 2016 and Sep 23, 2026 — classified as 39 injuries, 83 malfunctions.

The most frequently reported specific device problem is “Unsealed Device Packaging” (70 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

COMPACT INTUITIV 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-1007-2023 · Root cause: Process control · Recall details · FDA record ↗

Most reported COMPACT INTUITIV problems

COMPACT INTUITIV models

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

• COMPACT INTUITIV OPO80

  Unit, phacofragmentation
  1 recall74 reports
• COMPACT INTUITIV SCP680300

  Unit, phacofragmentation
  48 reports

Recent COMPACT INTUITIV adverse event reports

The 15 most recent reports across all models, 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 ↗

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