BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2121045 · Received June 9, 2011

    Report

    Report Number
    2023826-2011-00498
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 12, 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
    PA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - SURGICAL PROCEDURE, SECONDARY, EXPLANTED, LENS, VAULTING, EXCESSIVE. EVALUATION: METHOD - DEVICE HISTORY REVIEW: RESULTS: BASED ON THE INVESTIGATION, IT HAS BEEN DETERMINED THAT NOTHING IN THE MANUFACTURING OF THE LENS WAS THE ROOT CAUSE OF THE COMPLAINTS. SINCE THE LENS WAS NOT RETURNED IN ACCORDANCE TO THE DFU (RETURNED IN LIQUID), WE WERE UNABLE TO RE-MEASURE THE LENS. CONCLUSION ( NO DEVICE FAILURE): AT THE CONCLUSION OF THE ORIGINAL INVESTIGATION OPENED FOR THE ISSUE OF ICL VAULTING (BOTH INADEQUATE AND EXCESSIVE), IT WAS DETERMINED THAT THE MOST LIKELY ROOT CAUSE FOR BOTH INADEQUATE AND EXCESSIVE VAULT IS DIFFICULTY IN CLINICAL SIZING. IN NO CASE HAS A RETURNED LENS EXHIBITED A LENGTH MEASUREMENT OUTSIDE THE EXPECTED RANGE ACCORDING TO THE LABELED LENGTH. PRE-OPERATIVE MEASUREMENT TECHNOLOGY AVAILABLE TO CLINICIANS IN THE PAST DID NOT PROVIDE A DIRECT MEASUREMENT OF THE SULCUS, TO WHICH THE ICL SHOULD BE SIZED. THE CURRENT PRACTICE IN SELECTING AN APPROPRIATE ICL FOR A PATIENT IS TO MEASURE WHITE-TO-WHITE AND ANTERIOR CHAMBER DEPTH AND, THROUGH CORRELATIVE ALGORITHMS, PREDICT THE LENGTH OF THE ICL THAT WILL BRIDGE THE SULCUS. THIS METHOD OF SIZING BASED UPON WHITE-TO-WHITE AND ANTERIOR CHAMBER DEPTH MEASUREMENTS WAS USED IN THE FDA CLINICAL TRIAL AND IS RECOMMENDED IN THE CURRENT LABELING OF THE ICL. IF THE PREDICTED LENGTH IS TOO SHORT, THE RESULT MAY BE AN INADEQUATE VAULT. IF THE PREDICTED LENGTH IS TOO LONG, THE RESULT MAY BE AN EXCESSIVE VAULT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION METHOD: LENS WORK ORDER. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND THERE WERE NO SIMILAR COMPLAINTS 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 EVENT. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD - MEDICAL REVIEW. RESULTS: MEDICAL REVIEW - REVIEW OF THIS FILE INDICATES THAT THE ICL EXHIBITED A HIGH VAULT IN THIS PATIENT WHICH LED TO INCREASED IOP. THE ICL WAS REMOVED WHICH RESOLVED THE PROBLEM. THE ROOT CAUSE OF EXCESSIVE VAULTING HAS BEEN DETERMINED TO BE RELATED TO THE INACCURACY OF THE WHITE TO WHITE MEASUREMENT OR A MISMATCH BETWEEN WHITE TO WHITE AND THE SULCUS TO SULCUS DIAMETER. HOWEVER, THE SAME SIZE ICL WAS IMPLANTED IN THE OTHER EYE WITH NO OTHER SYMPTOMS. SURGEON BELIEVES THAT THE ICL WAS DEFECTIVE, NOT HAVING THE CORRECT MEASUREMENT WHICH CAUSED THIS PROBLEM. THE RETURNED ICL NEEDS TO BE RE-MEASURED TO RULE OUT THE PROBABILITY OF A DEFECTIVE LENS. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS - VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THE LENS WAS IN LIQUID WITH STRESS MARKS ON THE HAPTIC. THERE WAS A CLEAR SURGICAL RESIDUE ON THE LENS. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION CONCLUSION (UNABLE TO CONFIRM):BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, PRODUCT EVALUATION, MEDICAL AND DEVICE HISTORY REVIEW, 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 MICL12.6 IMPLANTABLE COLLAMER LENS ON (B)(6) 2011 AND WHEN THE PAIN RETURNED THE NEXT DAY SHE COMPLAINED OF PAIN. THE SURGEON OPTED TO MONITOR THE CONDITION AND AT THE PT'S NEXT OFFICE VISIT THE PRESSURE WAS UP TO 65. THE LENS WAS EXPLANTED ON (B)(6) 2011 AND THE PT IS CURRENTLY WEARING A CONTACT LENS. THE REPORTER INDICATED NO VAULTING WAS NOTED. SURGEON BELIEVES THE LENS IS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY MICL12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention