SOVEREIGN COMPACTRecalls & reported problems across all models

We found 2 models of SOVEREIGN COMPACT by Johnson & Johnson Surgical Vision, Inc. in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Aug 31, 2016 and Apr 17, 2025 — classified as 19 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (3 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 SOVEREIGN COMPACT problems

SOVEREIGN COMPACT models

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

• SOVEREIGN COMPACT CMP680300

  Unit, phacofragmentation
  22 reports
• SOVEREIGN COMPACT CMPR680300

  Unit, phacofragmentation
  1 report

Recent SOVEREIGN COMPACT adverse event reports

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

• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A ¿HALF-MONTH VISUAL ACUITY DECLINE IN THE RIGHT EYE. THE DIAGNOSIS INCLUDED A COMPLICATED CATARACT SURGERY IN THE RIGHT EYE WITH A PREVIOUS HISTORY OF SUSPECTED POSTERIOR CAPSULE DAMAGE THAT RESULTED IN POSTERIOR CAPSULE RUPTURE. AFTER THE PATIENT'S ADMISSION, RELEVANT TESTS AND EXAMINATIONS WERE COMPLETED TO CONFIRM THE DIAGNOSIS AND A PLANNED RIGHT EYE SECONDARY INTRAOCULAR LENS IMPLANTATION SURGERY WAS NEEDED. AFTER EXCLUDING SURGICAL CONTRAINDICATIONS, HE WAS SENT TO THE OPERATING ROOM AT ABOUT 15:30 ON (B)(6) 2025, FOR PHACOEMULSIFICATION CATARACT ASPIRATION USING THE SOVEREIGN COMPACT SYSTEM FOR THE RIGHT EYE, AND RIGHT ANTERIOR SEGMENT VITRECTOMY WAS PERFORMED AT APPROXIMATELY 16:20. THE ACCOUNT STATED THE ROTATION SPEED OF THE ANTERIOR SEGMENT VITRECTOR HEAD WAS SLOW, AND THE VITREOUS AND PART OF THE LENS CORTEX COULD NOT BE EFFECTIVELY REMOVED. AFTER MULTIPLE ATTEMPTS, THE LENS CORTEX IN THE VITREOUS COULD NOT BE COMPLETELY REMOVED, AND A SMALL AMOUNT OF LENS CORTEX REMAINED IN THE VITREOUS AFTER THE OPERATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21859021 ↗
• InjuryJul 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FAILED TO ACHIEVE THE PURPOSE OF VISUAL ACUITY IMPROVEMENT AND HAD TRANSIENT EDEMA IN THE OPERATIVE EYE, PUPIL DEFORMATION, AND IRREGULAR IRIS TEXTURE AFTER SURGERY. THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Corneal Edema; Eye Injury

  MAUDE report 19811806 ↗
• InjuryDec 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM COLLAPSING OF THE ANTERIOR CHAMBER DURING CATARACT SURGERY DUE TO POOR STABILITY OF THE PHACOEMULSIFICATION MACHINE. THE PROCEDURE WAS DELAYED AND THE PATIENT SUFFERED FROM CORNEAL EDEMA AND SUB-OPTIMAL RESULTS. THERE WAS HANDPIECE ISSUE REPORTED TOO. NO OTHER INTERVENTIONS WERE GIVEN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear; Corneal Edema

  MAUDE report 15947099 ↗
• MalfunctionJul 1, 2021Fire; Fire

  THE CUSTOMER REPORTED THAT THEIR SOVEREIGN COMPACT SYSTEM WAS SMOKING. THE SYSTEM HAS BEEN UNPLUGGED AND MOVED TO A SAFE AREA. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12103682 ↗
• InjuryApr 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGERY CENTER REPORTED CORNEAL EDEMAS AFTER CATARACT PROCEDURE USING A PHACOEMULSIFICATION UNIT. THE SURGEON HAS INFORMED FROM THE 15 SURGERIES PERFORMED AT 3 DAY POST OP, SURGERIES SHOWED EDEMAS AND THE REMAINDER WITH EDEMAS LEVEL 2+. THE SURGEON DOES NOT HAVE FURTHER INFORMATION ABOUT THE PATIENTS.

  Patient problems: Corneal Edema

  MAUDE report 7467349 ↗
• InjuryApr 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGERY CENTER REPORTED CORNEAL EDEMA AFTER CATARACT PROCEDURE USING A PHACOEMULSIFICATION UNIT. THE SURGEON INDICATED THERE WAS 7 POST OPERATIVE EXAMS AND THE PATIENT WAS NOTED TO HAVE EDEMA 1+ AND FOLD 3+. THE SURGEON INDICATED THE CELL COUNT WAS 2883 AND EFX SETTINGS WERE AT 17. THE SURGEON DOES NOT HAVE FURTHER INFORMATION ABOUT THE PATIENT OR DATE OF INCIDENT.

  Patient problems: Corneal Edema

  MAUDE report 7467240 ↗
• InjuryApr 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGERY CENTER REPORTED CORNEAL EDEMAS AFTER CATARACT PROCEDURE USING A PHACOEMULSIFICATION UNIT. THE SURGEON INDICATED SINCE THE PURCHASE OF THE PHACOEMULSIFICATION UNIT IN YEAR 2015, THERE HAS BEEN AROUND 300 CASES, IN WHICH THE SURGEON CONSIDERS AROUND 50 WERE CRITICAL. THE SURGEON DOES NOT HAVE FURTHER INFORMATION ABOUT THE PATIENT OR DATE OF INCIDENTS.

  Patient problems: Corneal Edema

  MAUDE report 7448836 ↗
• InjuryApr 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGERY CENTER REPORTED CORNEAL EDEMA AFTER CATARACT PROCEDURE USING A PHACOEMULSIFICATION UNIT. THE SURGEON INDICATED A CORNEAL TRANSPLANT WAS REQUIRED. THE SURGEON DOES NOT HAVE FURTHER INFORMATION ABOUT THE PATIENT OR DATE OF INCIDENT.

  Patient problems: Corneal Edema; No Code Available

  MAUDE report 7448814 ↗
• InjuryApr 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGERY CENTER REPORTED CORNEAL EDEMA AFTER CATARACT PROCEDURE USING A PHACOEMULSIFICATION UNIT. THE SURGEON INDICATED A CORNEAL TRANSPLANT WAS REQUIRED. THE SURGEON DOES NOT HAVE FURTHER INFORMATION ABOUT THE PATIENT OR DATE OF INCIDENT.

  Patient problems: Corneal Edema; No Code Available

  MAUDE report 7448796 ↗
• InjuryApr 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGERY CENTER REPORTED CORNEAL EDEMA AFTER CATARACT PROCEDURE USING A PHACOEMULSIFICATION UNIT.

  Patient problems: Corneal Edema

  MAUDE report 7400339 ↗
• InjuryMar 28, 2018Device Displays Incorrect Message; Device Operates Differently Than Expected; Device Displays Incorrect Message; Device Operates Differently Than Expected

  DURING A CATARACT EXTRACTION PROCEDURE, THE SURGERY CENTER REPORTED A CAPSULAR TEAR RESULTING IN AN ANTERIOR VITRECTOMY SURGICAL PROCEDURE. THE SURGERY CENTER INDICATED AT THE TIME OF THE EVENT AND DURING THE PROCEDURE, THE PHACOFRAGMENTATION UNIT STOP WORKING AND ERROR 212- PHACO-VITRECTOMY-DIATHERMY COMMUNICATION ERROR MASTER FAULT DISPLAYED. THE SURGERY CENTER INDICATED DUE TO THE EQUIPMENT HALTING TO A STOP, IT CAUSED DAMAGE TO THE POSTERIOR CAPSULE. THE SURGERY CENTER WAS ABLE TO COMPLETE THE CATARACT PROCEDURE. THE PATIENT OUTCOME IS EXPECTED WELL.

  Patient problems: Capsular Bag Tear; Vitrectomy

  MAUDE report 7376502 ↗
• InjuryDec 15, 2017Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  DURING A CATARACT EXTRACTION PROCEDURE, THE SURGERY CENTER REPORTED A CAPSULAR TEAR RESULTING IN A VITRECTOMY SURGICAL PROCEDURE. THE SURGERY CENTER INDICATED THE SURGEON HAD DIFFICULTY WITH MAINTAINING THE CHAMBER. THE SURGEON INDICATED THE VACUUM WAS EXCESSIVE AND REQUESTED AN EVALUATION OF THE UNIT. THROUGH FOLLOW UP, THE SURGERY CENTER INDICATED IT WAS A DIFFICULT CASE DUE TO THE PATIENT SQUEEZING. THE PATIENT HAS BEEN DOING WELL POST SURGERY.

  Patient problems: Capsular Bag Tear; Vitrectomy

  MAUDE report 7123245 ↗
• InjuryNov 17, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  A HOSPITAL REPORTED A CATARACT PATIENT PRESENTED WITH ENDOPHTHALMITIS AFTER UNDERGOING A PROCEDURE USING A COMPACT PHACO MACHINE. THE PATIENT REQUIRED ENUCLEATION OF THE EYE. THE PATIENT UNDERWENT THE INITIAL PHACO PROCEDURE ON (B)(6) 2017. THE UNIT WAS INSTALLED AT THE SURGICAL FACILITY IN (B)(6) 2016. AN ADDITIONAL TRAINING WAS GIVEN TO THE OPERATING NURSE ON (B)(6) 2017. ON (B)(6) 2017, THE COMPACT PHACO MACHINE WOULD NOT PASS SELF-TEST REPEATEDLY AND A 501-PRIME EXCESSIVE VACUUM ERROR WOULD DISPLAY. THE SURGERY CENTER HAD BEGUN THE CAPSULORRHEXIS WHEN THE MACHINE FAILED THE SELF-TEST. IT WAS REPORTED THERE WAS A DELAY OF 1.5 HOURS FOR COMPLETION OF THE PROCEDURE. A BACK UP MACHINE WAS BROUGHT IN TO COMPLETE THE PROCEDURE. THE SURGERY CENTER HAS NOT CONCLUDED THAT THE PHACO MACHINE AND PATIENT WITH ENDOPHTHALMITIS HAS ANY CORRELATION.

  Patient problems: Endophthalmitis; No Code Available

  MAUDE report 7043481 ↗
• InjuryAug 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGERY CENTER REPORTED CORNEAL EDEMA ON SOME PATIENTS AFTER CATARACT PROCEDURE USING A PHACOEMULSIFICATION UNIT. A BRIEF DESCRIPTION FROM THE SURGERY CENTER INDICATED THE SURGEON HAD MENTIONED 5 TO 6 PATIENTS WERE AFFECTED. FOLLOW UP REVEALED THE PHACOFRAGMENTATION SYSTEM WAS WORKING FINE BUT THE SURGERY CENTER WAS USING OLD TIPS. THE SURGERY CENTER PURCHASED NEW TIPS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Corneal Edema

  MAUDE report 6783803 ↗
• MalfunctionJun 22, 2017Smoking; Smoking

  THE ACCOUNT REPORTED OF BURNING SMELL FROM THE SOVEREIGN COMPACT CONSOLE. THERE WAS NO PATIENT INVOLVEMENT REPORTED AND NO PATIENT TREATMENTS DELAYED OR CANCELLED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS VISIBLE SMOKE COMING FROM THE CONSOLE.

  Patient problems: No Patient Involvement

  MAUDE report 6662134 ↗

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