BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1994406 · Received February 8, 2011

    Report

    Report Number
    2023826-2011-00088
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    December 22, 2010
    Report Date
    January 11, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - BLURRING. (B)(4) - LENS, VAULTING, LOW. EVALUATION METHOD: MEDICAL REVIEW. RESULTS: PER MEDICAL REVIEW - REVIEW OF THIS FILE INDICATES THAT THE PATIENT DEVELOPED AN ANTERIOR SUBCAPSULAR CATARACT 22 MONTHS POST ICL IMPLANTATION. THE ICL WAS REMOVED AND THE CATARACT IS BEING OBSERVED FOR ANY PROGRESSION. BCVA IS CURRENTLY 20/30 AFTER REMOVAL. ANTERIOR SUBCAPSULAR CATARACT IS A LABELED COMPLICATION IN THE IMPLANTATION OF AN ICL. CATARACT EXTRACTION MAY BE NECESSARY IF VISION IS COMPROMISED, TO PRECLUDE INCREASE IN SEVERITY OF THE CONDITION. IF THE CONDITION IS NON-PROGRESSIVE, THE SURGEON MAY OPT TO LEAVE THE ICL, ESPECIALLY WHEN THERE IS NO DECREASE IN VISUAL ACUITY. IN THE U.S. FDA CLINICAL TRIALS, APPROXIMATELY 6% TO 7% OF EYES DEVELOPED ANTERIOR SUBCAPSULAR OPACITIES AT 7 YEARS FOLLOWING ICL IMPLANTATION, BUT ONLY 1%-2% PROGRESSED TO CLINICALLY SIGNIFICANT CATARACT DURING THE SAME PERIOD. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, MEDICAL REVIEW AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND NO VISIBLE DAMAGE TO THE LENS. THE LENS WAS RETURNED DRY. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. THE LENS WAS REHYDRATED IN BSS FOR RE-MEASUREMENT. THE LENS LENGTH WAS MEASURED AND THE RESULT OF THE MEASUREMENT WAS COMPARED AGAINST THE ORIGINAL VALUE AND THE LENS WAS FOUND TO BE IN SPECIFICATION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4), SECONDARY SURGERY, (B)(4). EVAL: METHOD - (OTHER): LENS WORK ORDER SEARCH. RESULTS - (OTHER): A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND UNABLE TO DETECT ANY DAMAGE TO THE LENS DUE TO DRIED SURGICAL RESIDUE ON THE LENS SURFACE. CONCLUSIONS - (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND THE EVAL OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON IMPLANTED A 12.6MM MICL 12.6 IMPLANTABLE COLLAMER LENS IN THE PT'S RIGHT EYE (OD) ON (B)(6) 2009. THE ICL WAS EXPLANTED DUE TO THE DEVELOPMENT OF AN ANTERIOR SUBCAPSULAR CATARACT. ADDITIONAL INFO HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFO IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED: THE FACILITY REPORTED THE ICL HAD A LOW VAULT AND THE CATARACT WAS FIRST OBSERVED ON (B)(6) 2010. THE ICL WAS EXPLANTED ON (B)(6) 2011 AND THE CATARACT IS BEING OBSERVED FOR ANY PROGRESSION. THE PATIENT EXPERIENCED BLURRY VISION. THE PATIENT'S POST-OP BCVA WAS 20/30.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY MICL 12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention INJECTOR: MODEL AND LOT NUMBER UNK| FOAM TIP PLUNGER: MODEL AND LOT NUMBER UNK| CARTRIDGE: MODEL AND LOT NUMBER UNK