SOVEREIGN COMPACT CMP680300Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 05050474514706), received between Aug 31, 2016 and Apr 17, 2025 — classified as 19 injuries, 3 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, 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 22 most recent of 22 reports, 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 ↗
• 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 ↗
• InjuryMay 15, 2017Adverse 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. ALTHOUGH, ATTEMPTS WERE MADE, NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Eye Burn

  MAUDE report 6568220 ↗
• InjuryDec 27, 2016Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  DURING A CATARACT EXTRACTION PROCEDURE, THE SURGERY CENTER REPORTED FOREIGN MATERIAL ON THE OPERATIVE EYE. A BRIEF DESCRIPTION FROM THE SURGERY CENTER INDICATED THE SURGEON HAD PERFORMED FIVE (5) CATARACT PROCEDURES AND IT WAS THE FIFTH (5TH) PATIENT THAT WAS PRESENTED WITH THE FOREIGN MATERIAL UNDER THE SLIT LAMP ON A 2 DAY POST OP EXAM. THE SURGEON INDICATED THERE WAS A LARGE AREA OF GLITTER WAS NOTICED UNDER THE MICROSCOPE IN LEVEL THREE (3) PHACOEMULSIFICATION AND THERE WAS NO ISSUE IN LEVEL ONE (1) AND LEVEL TWO (2). IT WAS NOTED THE SIZE OF FOREIGN MATERIAL WAS ABOUT 0.8-0.9MM UNDER SEVEN (7) TIME¿S MICROSCOPE. IN ADDITION, THE SURGERY CENTER INDICATED WHEN THE ANTERIOR CHAMBER WAS IRRIGATED, IT WAS NOTED ¿SOMETHING GLITTER WHICH SEEMS AS ¿METAL DEBRIS¿ FOUND IN THE OPERATIVE EYE AND IT WAS SUSPECTED IF THE METAL MATERIAL WAS FROM THE HANDPIECE. THROUGH FOLLOW UP, THE SURGERY CENTER SUSPECTED THAT THE LIGHT-REFLECTING FOREIGN BODY WAS CRYSTAL SUBSTANCE, NOT METAL. WATER CANNON WERE USED TO FLUSH THE REUSABLE TUBING PACK. THE SURGERY CENTER INDICATED PERFUSATE IS COMPOUND SODIUM CHLORIDE SOLUTION. THERE WILL BE DEPOSIT OR CRYSTAL AFTER LONG USE. THERE WILL BE RESIDUE IN TUBE W

  Patient problems: Foreign Body Sensation in Eye

  MAUDE report 6207026 ↗
• InjuryDec 21, 2016Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  DURING A CATARACT EXTRACTION PROCEDURE, THE SURGERY CENTER REPORTED FOREIGN MATERIAL ON THE OPERATIVE EYE. A BRIEF DESCRIPTION FROM THE SURGERY CENTER INDICATED THE SURGEON HAD PERFORMED FIVE (3) CATARACT PROCEDURES AND IT WAS THE THIRD (3RD) PATIENT THAT WAS PRESENTED WITH THE FOREIGN MATERIAL UNDER THE SLIT LAMP ON A 2 DAY POST OP EXAM. THE PATIENT HAD NO CHIEF COMPLAINTS. IN ADDITION, THE SURGERY CENTER INDICATED WHEN THE ANTERIOR CHAMBER WAS IRRIGATED, IT WAS NOTED ¿SOMETHING GLITTER WHICH SEEMS AS ¿METAL DEBRIS¿ FOUND IN THE OPERATIVE EYE AND IT WAS SUSPECTED IF THE METAL MATERIAL WAS FROM THE HANDPIECE. THROUGH FOLLOW UP, THE SURGERY CENTER SUSPECTED THAT THE LIGHT-REFLECTING FOREIGN BODY WAS CRYSTAL SUBSTANCE, NOT METAL. WATER CANNON WAS USED TO FLUSH THE REUSABLE TUBING PACK. THE SURGERY CENTER INDICATED PERFUSATE IS COMPOUND SODIUM CHLORIDE SOLUTION. THERE WILL BE DEPOSIT OR CRYSTAL AFTER LONG USE. THERE WILL BE RESIDUE IN TUBE WHEN SALINE SOLUTION PASSES THROUGH IT. AFTER HIGH TEMPERATURE AND PRESSURE DISINFECTION, CRYSTAL OCCURS WHEN WATER EVAPORATES. THERE WILL BE RESIDUE IF FLUSHED BY WATER. FURTHERMORE, THE HANDPIECE AND TIP WERE EXAMINED TO DETECT IF THERE WAS A BREA

  Patient problems: Foreign Body Sensation in Eye

  MAUDE report 6196612 ↗
• MalfunctionDec 16, 2016Device Inoperable; Device Inoperable

  THE CUSTOMER REPORTED OF FOOTPEDAL FAILURE OCCURRED DURING SURGERY WITH THE SOVEREIGN COMPACT CONSOLE. THE SURGERY WAS ABORTED AND THE PATIENT WAS TAKEN TO ANOTHER HOSPITAL TO COMPLETE THE PROCEDURE. THE REST OF THE CASES WERE CANCELLED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6183089 ↗
• InjuryDec 12, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING A CATARACT EXTRACTION PROCEDURE, THE SURGEON REPORTED VITREOUS LOSS RESULTING IN AN UNPLANNED VITRECTOMY. A BRIEF DESCRIPTION FROM THE SURGERY CENTER INDICATED DURING THE CATARACT EXTRACTION PROCEDURE, THERE WAS VITREOUS LOSS RESULTING IN AN UNPLANNED VITRECTOMY PROCEDURE. IN ADDITION, THE SURGERY CENTER INDICATED THE VITRECTOMY CUTTER WAS NOT WORKING AND THE VITRECTOMY CUTTER WAS REPLACED TO COMPLETE THE PROCEDURE.

  Patient problems: Vitrectomy; Vitreous Loss

  MAUDE report 6168323 ↗
• MalfunctionOct 17, 2016Device Emits Odor; Smoking; Device Emits Odor; Smoking

  THE ACCOUNT REPORTED SMELL FROM THE SYSTEM, THAT VISIBLE SMOKE WAS OBSERVED WITH THE SOVEREIGN COMPACT CONSOLE. THERE WAS NO PATIENT INVOLVEMENT REPORTED AND NO PATIENT TREATMENTS DELAYED OR CANCELLED.

  Patient problems: No Patient Involvement

  MAUDE report 6032881 ↗
• InjuryAug 31, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGERY CENTER REPORTED TWO PATIENTS EXPERIENCING CORNEAL EDEMAS AFTER CATARACT PROCEDURE USING A PHACOEMULSIFICATION UNIT AND THERE WAS A POSSIBILITY OF CORNEAL TRANSPLANTS REQUIRED. THROUGH FOLLOW UP, THE SURGEON HAD INDICATED THE PATIENTS ARE HAVING IMPROVEMENTS AND GETTING BETTER MONITORED BY SURGEON AND NO SURGICAL INTERVENTION REQUIRED. ALTHOUGH SEVERAL ATTEMPTS WERE MADE FOR ADDITIONAL INFORMATION, NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR PATIENT 2 OF 2.

  Patient problems: Corneal Edema

  MAUDE report 5919729 ↗
• InjuryAug 31, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGERY CENTER REPORTED TWO PATIENTS EXPERIENCING CORNEAL EDEMAS AFTER CATARACT PROCEDURE USING A PHACOEMULSIFICATION UNIT AND THERE WAS A POSSIBILITY OF CORNEAL TRANSPLANTS REQUIRED. THROUGH FOLLOW UP, THE SURGEON HAD INDICATED THE PATIENTS ARE HAVING IMPROVEMENTS AND GETTING BETTER MONITORED BY SURGEON AND NO SURGICAL INTERVENTION REQUIRED. ALTHOUGH SEVERAL ATTEMPTS WERE MADE FOR ADDITIONAL INFORMATION, NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR PATIENT 1 OF 2.

  Patient problems: Corneal Edema

  MAUDE report 5919726 ↗