INFINITI VISION SYSTEM

Report

Report Number: 2028159-2015-10188
Event Type: Injury
Date Received: December 23, 2015
Date of Event: November 23, 2015
Report Date: January 19, 2016
Manufacturer: ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
Product Code: HQC
PMA / PMN Number: K120912
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: PHARMACIST

Narratives

Additional Manufacturer Narrative · 1

EVALUATION SUMMARY. THIS COMPLAINT FILE WAS REVIEWED BY A CLINICAL ANALYST, WHO STATED THE FOLLOWING: THE DEVICES SUSPECTED BY FACILITY ARE THE HANDPIECE AND THE STERILIZATION RINSE SOLUTION. THE RINSE SOLUTION WAS CHANGED ONE YEAR AGO. NO CHECK WAS PERFORMED ON THE STERILIZATION PROCESS BECAUSE THEY HAVE A TRACEABILITY SYSTEM. THE CUSTOMER REQUESTED TO THE STERILIZATION AGENT TO RINSE THE HANDPIECES ABUNDANTLY WITH DISTILLED WATER (BEFORE THESE CASES, THE HANDPIECES WERE RINSED WITH TAP WATER). THE PHARMACIST ORDERED AN ULTRASOUND TO IMPROVE THE HANDPIECE CLEANING. THE PHACO HANDPIECE DIRECTIONS FOR USE (DFU) INCLUDE THE WARNING: DO NOT ULTRASONICALLY CLEAN THE HANDPIECE. ULTRASONIC CLEANING OF THIS HANDPIECE WILL CAUSE IRREPARABLE DAMAGE. A POSSIBLE CAUSE OF THE EYE IRRITATIONS ARE INADEQUATE FLUSHING OF PHACO, IRRIGATION/ASPIRATION HANDPIECES AND CANNULATED EQUIPMENT, USE OF ENZYMATIC CLEANERS AND DETERGENTS, USE OF REUSABLE CANNULAS, INADEQUATE CLEANING OF INSTRUMENTS, USE OF PRESERVED EPINEPHRINE, REUSE OF SINGLE USE DEVICES, USE OF TAP WATER WITH NO STERILE WATER FINAL RINSE, INADEQUATE PERSONNEL OR TRAYS TO ALLOW PROPER PREPARATION OF INSTRUMENTS, NO IMMEDIATE CLEANING ALLOWING OPHTHALMIC VISCOELASTIC DEVICE (OVD) AND SURGICAL SOLUTIONS TO DRY ON INSTRUMENTS, USE OF PRESERVED MEDICINES IN THE EYE, REUSE OF TUBING FOR FLUSHING, LATEX BULBS FOR IRRIGATION, NOT TRAINING, NO TERMINAL STERILIZATION, INSTRUMENTS STORED ON TOWELS, TOUCHING OF IOL OR PATIENT CONTACT AREAS OF INSTRUMENTS WITH GLOVED HANDS, OFF-LABEL USE OF LIDOCAINE GEL, POOR INSTRUMENT MAINTENANCE, AUTOCLAVE RESIDUE, RUST, PARTICULATES, LINT, USE OF POWDERED GLOVES, ADDITIVES ADDED TO BALANCED SALT SOLUTION AGAINST DIRECTIONS FOR USE (DFU) , IMPROPER USE OF PREP SOLUTIONS, DETERGENTS AND CLEANERS, FAILURE TO FOLLOW MANUFACTURER¿S DIRECTIONS FOR USE, INCLUDING NO AIR FLUSH, USE OF UNAPPROVED ENZYMATIC CLEANERS, USE OF POSTOPERATIVE OINTMENT IN CLEAR CORNEAL CASES, POVIDONE-IODINE PLACED IN THE EYE AT THE END OF PROCEDURES, INCORRECT CONCENTRATION OF DETERGENTS AND ENZYMATIC CLEANERS. THE PHACOEMULSIFICATION SYSTEMS ARE CLOSED SYSTEMS. THEY ARE OPERATED WITH A STERILE SINGLE USE CONSUMABLE CASSETTE WHICH IS DESIGNED TO ISOLATE THE PATIENT FLUID PATH FROM THE CONSOLE ITSELF. ANY SURGICAL INSTRUMENTATION THAT WOULD COME INTO CONTACT WITH THE PATIENT WOULD BE CLEANED AND AUTOCLAVED BY THE USER PRIOR TO SURGERY, PER STANDARD INDUSTRY PRACTICES AND COMPANY DIRECTIONS FOR USE (DFU). THE DFU NOTES A MINIMUM OF 120CC OF STERILE DEIONIZED WATER ARE TO BE PUSHED OR DRAWN THROUGH BOTH THE IRRIGATION AND ASPIRATION PATHS. TAP WATER IS NOT RECOMMENDED FOR CLEANING THE PHACO HANDPIECE PATHWAYS. THERE IS NO EVIDENCE THAT THE DESIGN OR MANUFACTURING OF THE INFINITI SYSTEM OR PHACO HANDPIECES CONTRIBUTED TO THE REPORTED EVENT.¿ NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED FROM THIS CUSTOMER. WITH NO ADDITIONAL, RELATED INFORMATION PROVIDED, THE CUSTOMERS REPORTED EVENT WAS NOT ABLE TO BE CONFIRMED. THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

Additional Manufacturer Narrative · 1

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. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Description of Event or Problem · 1

A PHARMACIST REPORTED THAT FOUR PATIENTS WERE HOSPITALIZED DUE TO STRONG IRRITATION AFTER CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT. SAME SYSTEM WAS USED FOR ALL THE SURGERIES. AT THE TIME OF THE EVENT WAS REPORTED THE PATIENTS WERE STILL HOSPITALIZED WITH NO IMPROVEMENT. IT WAS NOTED THAT THE IRRIGATION SOLUTION USED HAD NO ADDITIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. THIS IS ONE OF TWO REPORTS BEING FILED FOR THE SAME ISSUE. THIS REPORT IS FOR A PATIENT WHO UNDERWENT SURGERY IN (B)(6).

Description of Event or Problem · 1

ADDITIONAL INFORMATION WAS PROVIDED BY THE ANESTHETIST. THE EVENT WOULD BE RELATED TO PHACO HANDPIECES. THE ANESTHETIST TOLD THAT THE MACHINE HAD BEEN USED SINCE THE EVENTS WITHOUT ANY PROBLEM. THE FACILITY PHARMACIST ALSO REPORTED THAT BY (B)(6) 2015 THE FOUR PATIENTS HAD ALREADY LEFT THE HOSPITAL. HE DID NOT KNOW THE CORRECTIVE TREATMENTS PRESCRIBED TO THE PATIENTS. THE PHARMACIST REPORTED THAT NO TASS WAS DIAGNOSED, IT WAS ONLY EYE IRRITATIONS, STRONG ENOUGH TO INDUCE HOSPITALIZATION. ACCORDING TO THE PHARMACIST, THE DEVICES SUSPECTED BY FACILITY ARE THE HANDPIECE AND THE STERILIZATION RINSE SOLUTION. THE RINSE SOLUTION WAS CHANGED ONE YEAR AGO THEY NOW USE IMMONIUM STERILY WHICH IS VERY EFFICIENT ACCORDING TO PHARMACIST. NO CHECK WAS PERFORMED ON THE STERILIZATION PROCESS BECAUSE THEY HAVE A TRACEABILITY SYSTEM. CURRENTLY THEY RINSE ABUNDANTLY THE HANDPIECES WITH DISTILLED WATER AFTER USING THE STERILIZATION AGENT AND ALSO BEFORE THE SURGERIES. THE PHARMACIST ORDERED A ULTRASOUNDS BOX TO IMPROVE THE HANDPIECES CLEANING. THIS IS ONE OF THREE REPORTS BEING FILED FOR THE SAME ISSUE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
848235	INFINITI VISION SYSTEM	UNIT, PHACOFRAGMENTATION	HQC	ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization