BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2193991 · Received August 5, 2011

    Report

    Report Number
    2023826-2011-00698
    Event Type
    Injury
    Date Received
    August 5, 2011
    Report Date
    July 13, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - SURGICAL PROCEDURE, SECONDARY SURGERY. EXPLANTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4): MEDICAL REVIEW - REVIEW OF THIS FILE INDICATES THAT THE ICL EXHIBITED A HIGH VAULT IN THIS PATIENT WHICH LED TO DISLOCATION OF THE ICL. THE ICL WAS EXCHANGED WITH A SHORTER LENS 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. SEVERAL CONDITIONS MAY ARISE FROM THIS EVENT (I.E. PUPILLARY BLOCK, MALIGNANT GLAUCOMA, INCREASED IOP ETC.) TO PREVENT ANY OF THESE COMPLICATIONS FROM OCCURRING, STAAR RECOMMENDS THAT THE LENS BE EXPLANTED AND/OR EXCHANGED WITH THE RIGHT SIZE ONCE THE SURGEON DETERMINES THAT THIS CONDITION MAY AFFECT OUTCOME OF THE PATIENT'S VISION. CONCLUSIONS - BASED ON THE COMPLAINT HISTORY AND MEDICAL REVIEW, 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. (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4). LENS NOT RETURNED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON WAS ANTICIPATING EXPLANTING A 12.6MM MICL 12.6 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S LEFT EYE (OS) DUE TO EXCESSIVE VAULTING AND THE LENS HAD DISLOCATED. THE ICL WILL BE EXCHANGED FOR A SHORTER LENS. THE REPORTER STATED MOST LIKELY THE EVENT WAS DUE TO MIS-MEASUREMENT OF THE WHITE-TO-WHITE. THE REPORTER STATED THE ICL WAS IMPLANTED BY A DIFFERENT SURGEON. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED - THE ICL WAS EXPLANTED ON (B)(6) 2011 WITH GOOD POST-OP RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CARTRIDGE MODEL AND LOT NUMBER UNK| INJECTOR MODEL AND LOT NUMBER UNK