BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 3743245 · Received March 24, 2014

    Report

    Report Number
    2028159-2014-00194
    Event Type
    Injury
    Date Received
    March 24, 2014
    Report Date
    January 17, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE REPORT FROM MEDICAL INNOVATION OF CHINA SEP 2013/VOL.10/NO.25. A LITERATURE REPORT WAS RECEIVED. THE STUDY AIMED TO INVESTIGATE WHETHER TRYPAN BLUE HELPS THE SUCCESSFUL COMPLETION OF CONTINUOUS CURVILINEAR CAPSULORHEXIS DURING EXFOLIATION SYNDROME COMBINED CATARACT SURGERY. SEVENTY SEVEN (77) PTS WERE RANDOMLY DIVIDED INTO TWO GROUPS, THE STAINING GROUP OF 42 PTS AND THE CONTROL GROUP OF 35 PTS. BOTH GROUPS UNDERWENT PHACOEMULSIFICATION CATARACT EXTRACTION AND INTRAOCULAR LENS IMPLANTATION. IN THE STAINING GROUP, TRYPAN BLUE CAPSULAR STAIN WAS USED, INTRAOPERATIVE SUCCESS RATE OF CONTINUOUS CURVILINEAR CAPSULORHEXIS, POSTERIOR CAPSULAR RUPTURE, IOL IMPLANTATION IN CAPSULAR BAG AND POSTOPERATIVE VISUAL RECOVERY WERE OBSERVED AND COMPARED STATISTICALLY WITH THE CONTROL GROUP. THE STAINING GROUP HAD CONTINUOUS CURVILINEAR CAPSULORHEXIS SUCCESS RATE OF 88%, CAPSULAR RUPTURE RATE OF 9%, AND RATE OF IOL IMPLANTATION IN CAPSULAR BAG OF 95%. THIS INVESTIGATION WAS OPENED TO INVESTIGATE POSTERIOR CAPSULE RUPTURE ON 15 EYES. THE CLINICAL ANALYST REVIEWED THE FILE. THE AUTHORS REPORT ON TWO GROUPS, BOTH WITH [PSEUDO] EXFOLIATION, UNDERGOING CATARACT EXTRACTION BY PHACOEMULSIFICATION. TRYPAN BLUE WAS USED TO STAIN THE ANTERIOR CAPSULE ON ONE GROUP, AND THE OTHER GROUP WAS OPERATED ON CONVENTIONALLY, WITHOUT TRYPAN PHACOEMULSIFICATION. TRYPAN BLUE WAS USED TO STAIN THE ANTERIOR CAPSULE ON ONE GROUP, AND THE OTHER GROUP WAS OPERATED ON CONVENTIONALLY, WITHOUT TRYPAN BLUE. THE AUTHORS NOTE THE FOLLOWING REGARDING PTS WITH [PSEUDO] EXFOLIATION SYNDROME; DUE TO DIFFICULTY OF FULL PUPIL DILATION, SUSPENSORY LIGAMENT LAXITY AND THIN CAPSULAR MEMBRANE, DURING CATARACT SURGERY, RADIAL TEAR OF CAPSULORHEXIS OPENING, SUSPENSORY LIGAMENT RUPTURE, POSTERIOR CAPSULE RUPTURE, VITREOUS LOSS AND OTHER SERIOUS COMPLICATIONS MAY EASILY OCCUR. THE AUTHORS NOTED THE POWER GENERATED FROM NUCLEUS CHOPPING AND TRANSLOCATING IN DIFFERENT DIRECTIONS DURING SURGERY AND INAPPROPRIATE INFUSION PRESSURE CAN EASILY RESULT IN SUSPENSORY LIGAMENT RUPTURE, LENS DISLOCATION, AND POSTERIOR CAPSULE RUPTURE. POSTERIOR CAPSULE RUPTURE IS A KNOWN CONSEQUENCE OF CATARACT EXTRACTION BY PHACOEMULSIFICATION. PREDISPOSITION TO POSTERIOR CAPSULE RUPTURE OR ZONULAR DEHISCENCE CAN BE INFLUENCED BY MANY FACTORS NOT LIMITED TO BUT INCLUDING; CONGENITAL POSTERIOR LENTICONUS, POOR VISIBILITY SECONDARY TO PTS COMORBIDITY [I.E. DENSE ARCUS, PTERYGIUM, BAND KERATOPATHY, CORNEAL SCARS INTERSTITIAL KERATITIS] POOR MICROSCOPE ILLUMINATION [RED REFLEX], ABNORMALLY LONG OR SHORT AXIAL LENGTHS, PSEUDOEXFOLIATION, ZONULAR LAXITY, POOR DILATION, DENSE CATARACTS, ASTEROID HYALOSIS, OR INADVERTENT PT MOVEMENT. IN CONCLUSION, THE AUTHORS ATTRIBUTE INCREASED INCIDENCE OF POSTERIOR CAPSULE RUPTURE AND VITREOUS LOSS TO PT PRE-EXISTING CONDITION AND/OR SURGICAL TECHNIQUE IN THIS CASE REPORT. THERE IS NO EVIDENCE IN THE LITERATURE THAT THE DESIGN OR PERFORMANCE OF THE SYSTEM HAD ANY ADVERSE EFFECT ON THE INTEGRITY OF THE PTS' POSTERIOR CAPSULES. LIKELY CONTRIBUTOR TO THE REPORTED IS PT PRE-EXISTING CONDITION AND/OR SURGICAL TECHNIQUE, AS REITERATED BY THE AUTHORS. THERE WAS NO SAMPLE RETURNED FOR EVAL AND NO ADD'L INFO PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. POSTERIOR CAPSULE TEAR IS AN ISSUE THAT IS OCCASIONALLY REPORTED WITH CATARACT SURGERY. HOWEVER, A REVIEW OF THE COMPLAINT TRENDS SHOWS THAT THE FREQUENCY REPORTED IS WITHIN KNOWN LEVELS FOR THIS EVENT. A ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A LITERATURE REPORT INDICATED THAT THERE WERE 15 POSTERIOR CAPSULE RUPTURES DURING SURGICAL PROCEDURES. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173590 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CTR INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other