BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 2133607 · Received June 16, 2011

    Report

    Report Number
    2023826-2011-00537
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 19, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD - MEDICAL REVIEW. RESULTS: MEDICAL REVIEW - REVIEW OF THIS FILE INDICATES THAT THE PATIENT EXPERIENCED A HYPEROPIC CHANGE DUE TO THE LENS SHIFTING. REFRACTIVE CHANGE OVER TIME IS SECONDARY TO THE CONTRACTION OF THE CAPSULAR BAG WHICH CAUSES THE IOL TO DISPLACE POSTERIORLY, CAUSING A RESULTANT CHANGE IN REFRACTION. THERE IS AN INCREASED INCIDENCE OF THIS PHENOMENON IN CASES WHERE A CAPSULORHEXIS IS LESS THAN 5.5MM. PERFORMING AN ANTERIOR YAG CAPSULOTOMY WILL RELIEVE THE TENSION ON THE CAPSULAR BAG AND PREVENT THE IOL DISPLACEMENT POSTERIORLY. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD - DEVICE HISTORY REVIEW. RESULTS: BASED ON THE RESULTS OF THE DHR REVIEW AND MEDICAL REVIEW THERE IS NOTHING WITHIN THE MANUFACTURING PROCESS THAT CAN BE IDENTIFIED TO CONFIRM THIS CLAIM. IT IS HIGHLY UNLIKELY THAT THE LENS WAS THE INCORRECT DIOPTER SINCE THE DIOPTER VERIFICATION FOR (B)(4) WAS SUCCESSFULLY COMPLETED AND ALL LENSES IN THE WORK ORDER WERE ACCOUNTED FOR. BASED ON THE INFORMATION AND FACTS PROVIDED BY THE SURGICAL CENTER, DHR REVIEW, MEDICAL REVIEW AND ROOT CAUSE ANALYSIS, IT IS MOST LIKELY THAT THE PATIENT'S REFRACTIVE SURPRISE WAS DUE TO THE CONTRACTION OF THE CAPSULAR BAG WHICH CAUSED THE IOL TO DISPLACE POSTERIORLY, CAUSING A RESULTANT CHANGE IN REFRACTION. THIS IS NOT A PRODUCT DEFECT. THEREFORE, THE ROOT CAUSE OF THIS COMPLAINT IS EXISTING CONDITIONS IN THE PATIENT'S EYE. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: LENS WORK ORDER SEARCH. A LENS WORK ORDER SEARCH WAS PERFORMED AND THERE WAS ONE SIMILAR COMPLAINT FOUND. CONCLUSION: (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY AND WORK ORDER SEARCH, WE WERE UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE OF THE EVENT. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE SURGEON IMPLANTED THE CC4204A COLLAMER PLATE LENS ON (B)(6) 2011 AND THE LENS WAS EXPLANTED ON (B)(6) 2011 DUE UNEXPECTED HYPEROPIA. THE LENS HAD SHIFTED IN THE EYE. THE LENS WAS WITH A 25.5 DIOPTER LENS AND THE PT IS DOING FINE WITH A VA OF 20/15. THE SURGEON INDICATED THE INCIDENT WAS THE RESULT O THE LENS CHANGING POSITION INSIDE THE BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY CC4204A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention