Description of Event or Problem · 1
IRITIS [IRITS]. CYSTOID MACULAR OEDEMA [MACULAR OEDEMAL]. CASE DESCRIPTION: SPONTANEOUS DEVICE CASE, LOCLOG# CA 20030982, COMPLAINT# 2669, ARGUS# 2003147303CA. CROSS REFERENCE WITH CASES 2003147293CA, 2003147300CA AND 2003147296CA. A PHYSICIAN REPORTED THA A PATIENT EXPERIENCED IRITIS IN RIGHT EYE AFTER THE IMPLANT OF A CEEON LENS MOD 913. THE PATIENT WAS SUFFERING ALSO FROM GLAUCOMA AND WAS TREATED WITH XALATAN (LATANOPROST). AT THE TIME OF THE REPORT PATIENT'S CONDITION DID NOT RESOLVE. FOLLOW-UP (05MAR03). THE FOLLOWING NEW INFORMATION HAS BEEN RECEIVED THROUGH A COMPLAINT INVESTIGATION REPORT: BECAUSE CONTINUED IN ADDITIONAL INFO SECTION THE INVESTIGATION WAS STARTED AT RECEIVING THE FIRST OF COMPLAINTS, THE INVESTIGATION WAS FOCUSED ON THE FIRST SIXTEEN RECEIVING COMPLAINTS. NO MATERIAL WAS RECEIVED. - MANUFACTURING DATES OF ALL 33 COMPLAINTS SPANNED THE PERIOD: DEC01-NOV02. - COMPLAINTS WERE INDEPENDENT MODEL. - COMPLAINT RECORDS REVEALED THAT NO OTHER COMPLAINTS WERE RECEIVED FROM THE REPORTED LOTS RELATED TO IRITIS. - LENSES FROM THESE LOTS WERE ALSO DISTRIBUTED TO OTHER COUNTRIES (116 CANADA, 570 OTHER). - AN INQUIRY AT OTHER MARKETING COMPANIES ABOUT IRITIS PROBLEMS REGARDING IMPLANTED LENSES FROM THESE LOT NUMBERS REVEALED THAT THERE WERE NO KNOWN ADVERSE EVENTS. IRITIS COULD BE GENERATED BY THE FOLLOWING FACTORS: 1) MECHANICAL FACTORS: - LENS TYPE DESIGN: NO RELATIONS TO THE DESIGN OF THE CONCERNED COMPLAINT LENS MODEL 911, 913 AND TECNIS EXPECTED. DID NOT CONCERN IN-SULCUS OR IRIS CLIP DESIGNS. - MANUFACTURING DEFECTS: NCR'S REVEIWED: ONE NCR AT INCOMING INSPECTION ON LOOPS (FROM DEVIATION). THIS NCR WAS SETTLED AND THE LOOPS WERE RELEASED. NO OTHER DEVIATIONS WERE FOUND IN RELATION TO IRITIS. YIELD DATA WERE REVIEWED AND NO RELATION WAS FOUND. ONLY ONE INTRAOCULAR LENS WAS RETURNED FROM STOCK AND NO DIMENSION DEVIATION WAS FOUND. TRACEABILITY REVIEW SHOWED NO PATTERNS THAT INDICATED A COMMON CAUSE. - LENS FIXATION: WAS NOT APPLICABLE (CAPSULAR BAG PLACEMENT). - HAPTIC/OPTIC UVEAL (IRITIS) CHAFING: NO IN-SULCUS PLACEMENT. THE INVOLVED DOCTORS WERE EXPERIENCED SURGEONS. NO LOOP SHAPE DEVIATIONS WERE INDENTIFIED/REPORTED. 2) IRRITATING COMPOUNDS: - ENVIRONMENTAL CONTROL: RECORDS FROM THE YEAR 2002 WERE REVIEWED AND NO DEVIATIONS WERE FOUND. THE ENVIRONMENTAL CONTROL CONSISTS OF THE FOLLOWING: AIR SAMPLING (MICROBIOLOGICAL CONTAMINATION), PARTICLE COUNTING, RODAC SAMPLING (WORK BENCHES), BIOBURDEN MONITORING ON POST-STERLIZED PRODUTS, MONITORING OF WATER QUALITY (ENDOTOXIN, TOTAL ORGANIC COMPOUND, CONDUCTIVITY, PH, BIOBURDEN). - MATERIAL BATCH RECORDS: THE SILICONE BATCHES AND THE RAW MATERIAL BATCHES OF HAPTICS WERE VERIFIED AND NO DEVIATIONS WERE FOUND. 3) STERILIZATION PROCESS: - STERILIZATION PROCESS: - STERILIZATION BATCH RECORDS: THE SERIAL NUMBERS OF THE COMPLAINTS WERE ALL FROM DIFFERENT STERILIZATION BATCHES. FROM THESE BATCHES THE STERILIZATION PROCESS AND THE STERILITY TEST RESULTS, INCLUDED POSITIVE AND NEGATIVE CONTROLS WERE REVIEWED AND SHOWED NO DEVIATIONS. THE SPORE STRIPS AND TSB MEDIUM USED FOR STERILITY TEST WERE VERIFIED AND SHOWED NO DEVIATIONS. NO DEVIATIONS FOUND TO SPECIFIC STERILIZATION BATCHES. 4) BIOCOMPATIBLITY: CHANGE CONTROL SYSTEM: THE CHANGE CONTROL SYSTEM DURING 2002 WAS REVEIWED AND NO MATERIAL/PROCESS CHANGES WERE IMPLEMENTED THAT COULD BE RELATED TO THESE COMPLAINTS. BASED ON THE ABOVE ARGUMENTS, A MANUFACTURING RELATED CAUSE COULD NOT BE BE IDENTIFIED. THE REPORTING QUALITY ASSURANCE STATED THAT THEY WOULD ENTER THESE COMPLAINTS INTO A LONG-TERM DATABASE FOR AGGREGATION OF COMPLAINTS AND IDENTIFICATIONS OF POSSIBLE TRENDS. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MEDICAL PERSONNEL, USER FACILITY, DISTRIBUTOR, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. FOLLOW-UP (12MAR03 AND 14MAR03 MERGED). THE FOLLOWING INFORMATION HAS BEEN PROVIDED: IN 2003 THE LENS 913A WAS IMPLANTED DUE TO CATARACT THROUGH A PHAKO TECHNIQUE. BSS AND AMVISC WERE USED DURING THE SURGERY; TOBRADEX AND AULIN (THIS LAST DRUG NAME WAS NOT WELL READABLE) WERE ADMINISTERED POST OPERATIVELY. THE FOLLOWING MONTH, XALATAN, USED FOR THE TREATMENT OF GLAUCOMA, WAS DISCONTINUED AND A TREATMENT WITH TIMOPTIC WAS STARTED. ON THE SAME DAY, THE PATIENT, WHOSE MEDICAL HISTORY DID NOT INCLUDE IRITIS/UVEITIS, EXPERIENCED IRITIS THAT WAS CONSIDERED SERIOUS FOR INTERVENTION REQUIRED AND DISABILITY. BESIDES, PERMANENT IMPAIRMENT OF BODY FUNCTION WAS TICKED AS SERIOUSNESS CRITERION FOR IRITIS BY THE REPORTING PHYSICIAN DESPITE HE HAD MADE A GENERAL STATEMENT THAT THE USE OF STEROIDS WAS TO PREVENT A PERMANANT VISUAL IMPARIMENT. PHOTOPHOBIA, PAIN AND REDUCED VISION WERE THE MAIN SYMPTOMS OF IRITIS; CILIARY INJECTION AND FLARE +++ WERE THE SIGNS. IRITIS WAS TREATED BY THE TOPICAL ADMINISTRATION OF CORTICOSTEROIDS AND NSAIDS. ON A NOT SPECIFIED DATE THE PATIENT EXPERIENCED ALSO CYSTOID MACULAR OEDEMA ON WHICH NO ASSESSMENT OF SERIOUSNESS WAS PROVIDED BY THE REPORTING PHYSICIAN. THE COMPANY PROVIDED THE SAME SERIOUSNESS CRITERIA AS FOR IRITIS. AT THE TIME OF THE REPORT, THE PATIENT WAS REPORTED AS NOT YET RECOVERED.