CONSTELLATION VISION SYSTEM
Report
- Report Number
- 2028159-2019-02249
- Event Type
- Injury
- Date Received
- December 12, 2019
- Date of Event
- November 20, 2019
- Report Date
- May 4, 2020
- Manufacturer
- ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
- Product Code
- HQC
- PMA / PMN Number
- K101285
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
ADDITIONAL INFORMATION IS PROVIDED H.10. THE CUSTOMER RETURNED VIDEOS FOR REVIEW ON THE EVENT. THERE WERE EIGHT (8) VIDEOS SUBMITTED FOR THIS REVIEW. THE EIGHT (8) VIDEOS ARE A SEQUENTIAL LOOK AT THE ENTIRE COMBINED PROCEDURE AS A WHOLE. COMBINED PROCEDURE EQUATES TO ¿CATARACT EXTRACTION WITH INTRAOCULAR LENS IMPLANT (CE W/ IOL) AS WELL AS A VITREORETINAL PROCEDURE¿ TO FOLLOW. THE VIDEO-LABELED 001 CONTAINS IMAGES THAT PERTAIN THE PHACOEMULSIFICATION BURN REPORTED. THE FOLLOWING DETAILS ARE A REVIEW OF VIDEO 001 ONLY, AS THE VITREORETINAL PORTION DOES NOT PERTAIN TO THE INVESTIGATION. THE FIRST VIDEO-LABELED 001 STARTS WITH THE LID SPECULUM PLACED AFTER THE EYE WAS PREPPED FOR SURGERY. THERE IS NO AUDIBLE SOUND ATTACHED TO THE VIDEO. THE CAMERA MOVES SIGNIFICANTLY IN AND OUT OF FRAME AND THEN THE EYE IS STEADIED. BALANCE SALT SOLUTION (BSS) IS INSTILLED ON THE SURFACE OF THE CORNEA, FOLLOWED BY A SUBSTANCE, WHICH APPEARS TO BE SIMILAR TO THE OPHTHALMIC VISCOELASTIC DEVICE (OVD) (BUT HAS A BLUE HUE TO IT). THE PLASTIC SHEETING USED TO PROTECT THE EYE IS SNIPPED AT THE NASAL SIDE FIRST, FOLLOWED BY THE TEMPORAL SIDE. THE POSITION OF THE EYE INDICATES THAT THIS IS THE PATIENTS¿ RIGHT EYE (OD). MORE BSS IS INSTILLED ONTO THE CORNEA (FOR HYDRATION) AND THEN THE SURGEON USES A PALPATION TECHNIQUE TO THE TEMPORAL SIDE OF THE EYE WITH A FINGER. THE CONJUNCTIVAL DISSECTION OCCURS FROM 2-6 O¿CLOCK HOURS (TEMPORALLY), FOLLOWED BY A SECOND CONJUNCTIVAL DISSECTION FROM 6-10 O¿CLOCK HOURS (NASALLY). WECK-CELL SPONGES AND OTHER INSTRUMENTS ARE USING TO CLEAR THE EXTRA LIQUIDS AWAY. IT IS AT THIS TIME THAT THE FIRST (1) OF FIVE (5) TROCARS ARE INSTALLED INTO THE EYE. TROCAR PORT NUMBER ONE (1) ENTRY WAS PLACED AT THE 8 O¿CLOCK POSITION AND IS BLUE/TEAL IN COLOR. THIS SIGNIFIES THE TROCAR IS A (25G) GAUGE. TROCAR PORT NUMBER TWO (2) ENTRY WAS PLACED AT THE 4 O¿CLOCK HOUR AND IS BLUE/TEAL IN COLOR. THIS SIGNIFIES THE TROCAR IS A (25G) GAUGE. THERE WERE TWO VALVED-ENTRY INFUSION PORTS INSERTED. THE FIRST WAS FOR PORT NUMBER THREE (3) ENTRY, WHICH WAS PLACED AT THE 10 O¿CLOCK POSITION AND ANOTHER (PORT NUMBER FOUR-4) ENTRY WAS PLACED AT THE 2 O¿CLOCK POSITION. BOTH ARE CLEAR/WHITE IN COLOR. TROCAR PORT NUMBER FIVE (5) ENTRY WAS PLACED AT THE 3 O¿CLOCK POSITION AND IS BLUE/TEAL IN COLOR. THIS SIGNIFIES THE TROCAR IS A (25G) GAUGE. FOLLOWING THE INSERTION OF ALL FIVE (5) PORTS, THREE INCISIONS ARE MADE. THE FIRST (1) MAIN ¿LIMBAL INCISION¿ IS MADE AT THE 5 O¿CLOCK HOUR (TEMPORALLY). A SECOND (2) LIMBAL PARACENTESIS IS MADE AT THE 3 O¿CLOCK HOUR (TEMPORALLY). A THIRD (3), LIMBAL INCISION IS MADE AT THE 8 O¿CLOCK HOUR (NASALLY). VISCOELASTICS ENTER THE S SECOND (2) PARACENTESIS INCISION FOR WORKING SPACE INTO THE ANTERIOR CHAMBER (AC). MORE ¿BLUE-HUED¿ VISCOELASTICS WERE PLACED ONTO THE SURFACE OF THE CORNEA. AT THE SECOND (2) PARACENTESIS INCISION, A MANUAL CAPSULOTOMY WAS COMPLETED WITHOUT ISSUE. THE PATIENTS¿ EYE (OR THE PATIENT) BEGIN TO MOVE RAPIDLY IN AND OUT OF FRAME. THE IMAGE FINALLY STEADIES AND THEN A WECK-CELL IS USED TO CLEAR AWAY SOME OF THE ACCUMULATED LIQUIDS. A DIAMOND BLADE IS THEN USED TO ENTER INTO THE ANTERIOR CHAMBER (AC). TWO MORE INSTRUMENTS ENTER AND EXIT THE AC AND THE LENS NUCLEUS IS FREED FROM THE CAPSULE VIA A SERIES OF ROTATIONS. THE PHACOEMULSIFICATION HANDPIECE (PHACO-HP) ENTERS THE EYE VIA THE MAIN INCISION AT THIS TIME. THE INCISION LOOKS TO BE ON THE TIGHT SIDE AS THE SURGEON BEGINS TO SWEEP OVER THE NUCLEUS A FEW TIMES. BLOOD ACCUMULATION CAN BE SEEN AT THE ENTRY POINT. SOME OF THE VISCOELASTIC IS ASPIRATED INTO THE PHACO HP. THE SURGEON BEGINS THE FIRST GROOVES INTO THE CATARACT WHEN SMALL PARTICLES CAN BE SEEN IN THE ASPIRATION LINE. IMMEDIATELY LENS MILKING IS DETECTED AND THE BLOOD (WHICH HAD ACCUMULATED AT THE ENTRANCE OF THE WOUND) IS SEEN COAGULATED AND THE CORNEA IS OBSERVED AS WHITE IN COLOR JUST BEYOND THE BLOOD COAGULATION. THE SURGEON REMOVES THE HP FROM OF THE EYE AND IT IS OBSERVED THAT THE SURGEON TRYING TO FREE ANY OCCLUSIONS (JUST OFF CAMERA, VIA IRRIGATION SPRAYS). THE HP ENTERS THE EYE AGAIN AND THE SURGEON IS OBSERVED COMPLETING THE DIVIDE AND CONQUER TECHNIQUE. FRAGMENTS OF THE NUCLEUS ARE SEEN BEING EMULSIFIED AND A SLIGHT TRAMPOLINING EFFECT CAN BE SEEN. THE HP IS REMOVED FROM THE EYE ONCE ALL FRAGMENTS ARE ASPIRATED. THE IRRIGATION/ASPIRATION (I/A) INSTRUMENT IS THEN INTRODUCED TO THE EYE WITH OTHER INSTRUMENTATION TO CLEAN UP THE AC. THE SURGEON ATTEMPTS TO HYDRATE THE TWO (2) PARACENTESIS INCISION SITES. A WECK-CELL IS THEN USED TO WIPE ACCESS LIQUIDS FROM THE INCISION SITES. IMMEDIATELY FOLLOWING THIS, THE IOL IS INSERTED WITHOUT ISSUES VIA INCISION #1. INCISIONS #2 AND #3 ARE RE-HYDRATED. VIA INCISION SITE #1, THE I/A INSTRUMENT IS REINTRODUCED INTO THE AC FOR IOL POLISH/CLEANING. A FIRST SUTURE IS PLACED AT THE INCISION SITE #1 (WHERE THE CORNEAL BURN OCCURRED). BSS IS ADMINISTERED AND THE SURGEON¿S FINGER IS SEEN ON THE #1 INCISION WOUND. INCISIONS #2 AND #3 ARE REHYDRATED AGAIN TO SEAL THE ENTRY POINT. MORE VISCOELASTICS ARE PLACED OVER THE CORNEA AND A SECOND (2) SUTURE IS PLACED INTO INCISION #1. THE VIDEO ENDS. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS:(B)(4).
THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
ADDITIONAL INFORMATION IS PROVIDED IN D.10., G.1., G.2., H.3., H.6. AND H.10. CORNEAL THERMAL INJURIES ARE TYPICALLY RELATED TO EXCESSIVE HEAT GENERATED BY THE PHACO TIP DUE TO INSUFFICIENT ASPIRATION FLOW, EXTENDED ENERGY APPLICATION, OR COMBINATION OF BOTH. THE VISION SYSTEM IS DESIGNED TO COOL THE PHACO TIP DURING USE AS ASPIRATED FLUID FLOWS THROUGH THE TIP LUMEN. OVERHEATING OF THE PHACO TIP, HOWEVER, MAY OCCUR DUE TO EXTENDED APPLICATION OF ULTRASONIC ENERGY OR COMPROMISED ASPIRATION FLOW THROUGH THE PHACO TIP. REDUCED FLUID FLOW THROUGH THE PHACO TIP MAY BE CAUSED BY PHACO TIP RE-USE, TIP CLOGGING BY NUCLEAR MATERIAL, KINKED TUBING, INADEQUATE FLOW AND VACUUM SETTINGS, OR OBSTRUCTION BY OPHTHALMIC VISCOELASTIC DEVICE (OVD). WHEN THE PHACO TIP IS OCCLUDED, INFUSION WILL CEASE, REDUCING THE COOLING EFFECT OF THE TIP. OCCLUSION TONES (INTERMITTENT BEEPING TONES DURING OCCLUSION) ALERT THE USER, INDICATING THAT THE VACUUM IS NEAR OR AT ITS PRESET LIMIT, AND ASPIRATION FLOW IS REDUCED OR STOPPED. THE SURGEON MUST RECOGNIZE THE OCCLUSION TONES AND MANUALLY STOP THE ULTRASOUND MODE IN ORDER TO PREVENT A RAPID TEMPERATURE INCREASE. THE OPERATORS MANUAL INCLUDES THE WARNING: GOOD CLINICAL PRACTICE DICTATES TESTING FOR ADEQUATE IRRIGATION, ASPIRATION FLOW, REFLUX, AND OPERATION AS APPLICABLE FOR EACH HANDPIECE PRIOR TO ENTERING EYE. APPROPRIATE USE OF VISION SYSTEM PARAMETERS AND ACCESSORIES IS IMPORTANT FOR SUCCESSFUL PROCEDURES. USE OF LOW VACUUM LIMITS, LOW FLOW RATES, LOW IRRIGATION PRESSURE, HIGH POWER SETTINGS, EXTENDED POWER USAGE, POWER USAGE DURING OCCLUSION CONDITIONS (BEEPING TONES), FAILURE TO SUFFICIENTLY ASPIRATE VISCOELASTIC PRIOR TO USING POWER, EXCESSIVELY TIGHT INCISIONS, AND COMBINATIONS OF THE ABOVE ACTIONS MAY RESULT IN SIGNIFICANT TEMPERATURE INCREASES AT INCISION SITE AND INSIDE THE EYE, AND LEAD TO SEVERE THERMAL EYE TISSUE DAMAGE. DIRECTING ENERGY TOWARD NON-LENS MATERIAL, SUCH AS IRIS OR CAPSULE, MAY CAUSE MECHANICAL AND/OR THERMAL TISSUE DAMAGE. USE OF INCISIONS THAT ARE SMALLER THAN RECOMMENDED DURING LENS REMOVAL CAN LEAD TO MECHANICAL AND/OR THERMAL DAMAGE TO THE EYE TISSUE. CORNEAL BURN IS AN ISSUE THAT IS OCCASIONALLY REPORTED WITH CATARACT SURGERY. ACCORDING TO THE PENNSYLVANIA PATIENT SAFETY ADVISORY ABSTRACT: PREVENTING CORNEAL BURNS DURING PHACOEMULSIFICATION, MARCH 2010, VOL. 7, NO. 1: 23-25, MOST CORNEAL BURNS CAN BE TRACED TO ISSUES RELATED TO SURGICAL TECHNIQUE AND NOT TO MALFUNCTIONING EQUIPMENT. THE CUSTOMER DID NOT REQUEST SERVICE FOR THE SYSTEM. THE SYSTEM MANUFACTURING DEVICE HISTORY RECORD (DHR) WAS REVIEWED. BASED ON QA ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE PHACO TIP WAS NOT RECEIVED FOR EVALUATION; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. A REVIEW OF THE DEVICE HISTORY RECORDS TRACEABLE TO THE REPORTED LOT NUMBER INDICATES THAT THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA. ALL PHACO TIPS ARE 100% VISUALLY INSPECTED BY TRAINED OPERATORS USING 30X MAGNIFICATION DURING THE MANUFACTURING PROCESS. THE CASSETTE AND TUBING MANIFOLDS WERE RETURNED LOOSELY IN A BAG. THE VISUAL INSPECTION OF THE COMBINED CASSETTE DID NOT FIND AN OBVIOUS DEFECT THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. A CALIBRATED SYSTEM WAS THEN USED TO EVALUATE THE CASSETTE. THE BALL IN THE DRIP CHAMBER¿S CHECK VALVE MOVED FREELY PER SPECIFICATION. THE NON-INVASIVE FLOW SENSOR (NIFS) ON THE CASSETTE HOUSING WAS IN GOOD CONDITION. THE LED RINGS ON THE CONSOLE TURNED GREEN AS THE PROBE CONNECTORS WERE ENGAGED TO THE SYSTEM INDICATING THE PROPER COMMUNICATION BETWEEN THE PROBE AND THE SYSTEM. THE 7500 CUT RATE DISPLAYED ON THE SCREEN WHEN THE RADIO FREQUENCY IDENTIFICATION (RFID) WAS CONNECTED TO THE SYSTEM. THE CASSETTE COULD PRIME AND TUNE WITH THE 0.9MM ABS TIP AND INFUSION SLEEVE FROM THE LAB STOCK, AND PASS INTRAOCULAR PRESSURE (IOP) CALIBRATION SUCCESSFULLY. THE INFUSION PRESSURE, IRRIGATION, AND ASPIRATION RATE WERE ALL MEASURED AT MULTIPLE SET POINTS AND MET SPECIFICATIONS. THE IOP WAS STABLE DURING FUNCTIONAL AND PERFORMANCE TESTING. THE IOP STAYED ACTIVE DURING TESTING PROCESS. TOGGLING THE INFUSION AND THE FLUID/AIR EXCHANGE (F/AX) MODES, FLUID AND AIR FLOWED FROM THE CASSETTE TO THE INFUSION LINE CONTINUOUSLY WITHOUT ANY BUBBLE IN VARIOUS SETTINGS IN ALL SUB MODES. NO SYSTEM MESSAGE (SM) APPEARED ON THE SCREEN DURING FUNCTIONAL TESTING. THE FLUID FLOWED FROM THE BALANCED SALT SOLUTION (BSS) BOTTLE/BAG TO THE DRAIN BAG WITHOUT ANY INTERFERING. NO LEAKAGE WAS DETECTED FROM THE PUMP ELASTOMER OR ON THE PUMP AREA OF THE FLUIDICS MODULE. THE CLEANING PROCESS COULD BE PERFORMED AFTER FUNCTIONAL TEST HAD COMPLETED. THE CASSETTE MET PRODUCT SPECIFICATIONS. THE CUSTOMER DID NOT RETAIN THE CASSETTE LOT NUMBER; THEREFORE, THE DEVICE HISTORY RECORDS TRACEABLE TO THE REPORTED PROCEDURE PACK COULD NOT BE REVIEWED. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT VISUAL ACUITY (VA) WAS 0.06 ON (B)(6) 2019 AND IMPROVED TO 0.3 ON (B)(6) 2020. THE INTRAOCULAR PRESSURE (IOP) IS STABLE AT AROUND 15 MMHG. THERE WAS A WRINKLE ON THE CORNEA DUE TO LOW IOP BEFORE BUT NOW THAT THE IOP BECAME STABLE THERE APPEARS TO HAVE LESS WRINKLES AND MOST LIKELY WILL FULLY RECOVER SOON. THE PHYSICIAN STATES THERE WILL BE NO MEDICAL CONCERNS. THE PATIENT IS STILL COMPLAINING THAT THERE IS DIFFICULTY SEEING AS THE PREOPERATIVE VA WAS 0.06.
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).
A SURGEON REPORTED THAT DURING A TRIPLE PROCEDURE THE PATIENT EXPERIENCED A THERMAL BURN. THE INCISION SITE WAS 3MM. THE SURGERY WAS PERFORMED AND COMPLETED WITHOUT PRODUCT REPLACEMENT. THE WOUND WAS NOT CLOSED SO THE WOUND WAS COVERED WITH OPHTHALMIC VISCOSURGICAL DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1250867 | CONSTELLATION VISION SYSTEM | UNIT, PHACOFRAGMENTATION | HQC | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER | TABLETOP-JAPAN | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention | 25+ CMB PAK 7.5CPM V,STD .9| MT FLARED ABS 30R| OPEGAN-HI| SHELLGAN |