BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 4102212 · Received September 19, 2014

    Report

    Report Number
    2023826-2014-00720
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 27, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY RECORD REVIEW. RESULT: BASED ON THE RESULTS OF THE INVESTIGATION, ALL RELEASED DEVICES FROM THE ASSOCIATED WORK ORDER(S), INCLUDING THE SUSPECTED DEVICE, HAVE BEEN MANUFACTURED WITHIN THE ESTABLISHED PROCESS PARAMETERS; AND THERE IS NO INDICATION THAT THE MANUFACTURING AND PROCESSING OF THE DEVICE CONTRIBUTED TO THE COMPLAINT ISSUE. CLAIM #(B)(4).

    Additional Manufacturer Narrative · 1

    DATE OF BIRTH - UNK. (B)(4). METHOD: WORK ORDER SEARCH. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. CONCLUSIONS: (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY AND WORK ORDER SEARCH, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    METHOD: MEDICAL REVIEW. RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND NO VISIBLE DAMAGE TO THE LENS. THE LENS WAS RETURNED IN LIQUID. MEDICAL REVIEW - REPORTEDLY ICL (13.2MM) WAS EXPLANTED/EXCHANGED FOR A SHORTER LENGTH ICL (12.6 MM), ONE WEEK POSTOPERATIVELY, TO ADDRESS EXCESSIVE LENS VAULT AND SUBSEQUENT ELEVATED IOP. THE PATIENT PRESENTED WITH ELEVATED IOP ON THE FIRST POST-OP DAY AND THE SURGEON PERFORMED SECONDARY SURGICALLY INTERVENTION (RE-OPENING OF PIS). THE PROCEDURE WAS NOT SUCCESSFULLY SO HE DECIDED TO EXPLANT/EXCHANGE THE LENS. THE SURGERY WAS UNEVENTFUL. NO REPORTED POSTOPERATIVE SEQUELAE. IT SHOULD BE NOTED THAT AT THE TIME OF THE SURGERY THE PATIENT WAS (B)(6), AND PER DFU THE VISIAN ICL IS INDICATED FOR IMPLANTATION IN ADULTS 21-45 YEAR OF AGE, THEREFORE THERE IS INSUFFICIENT DATA TO SUPPORT IMPLANTATION IN SUCH PATIENTS. THE LITERATURE REPORTS THAT PERSISTENT RISE IN IOP/PUPILLARY BLOCK IS FREQUENTLY ASSOCIATED WITH INADEQUATE PREOPERATIVE IRIDOTOMIES AND/OR EXCESSIVE ICL VAULT USUALLY DUE TO AN OVERESTIMATION OF ICL SIZE. GIVEN THE INFORMATION THAT DIFFERENT LENS LENGTH WAS IMPLANTED AS A REPLACEMENT IT IS VERY LIKELY THAT PROCEDURE RELATED FACTOR (MISCALCULATION) HAVE CAUSED THE REPORTED EVENT. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, MEDICAL REVIEW AND THE EVALUATION OF THE RETURNED PRODUCT, A LIKELY CAUSE OF THE EVENT WAS PROCEDURE RELATED FACTOR (MISCALCULATION). (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2014. THE REPORTER STATED THE SURGERY WENT WELL AND THE PATIENT WAS SENT HOME. THE PATIENT RETURNED THE NEXT DAY, (B)(6) 2014, WITH ELEVATED INTRAOCULAR PRESSURE (OVER 50MMHG), SHALLOW CHAMBER AND THE LENS HAD AN EXCESSIVE VAULT. THE STANDARD PROCEDURES WERE PERFORMED TO LOWER THE PRESSURE (THE PIS WERE LASERED) BUT WAS UNSUCCESSFUL. THE REPORTER STATED THERE WERE NO ADDITIONAL COMPLICATIONS RELATED TO THE EVENT. THE PATIENT RETURNED ON (B)(6) 2014 AND THE LENS WAS EXPLANTED. THE LENS WAS EXCHANGED FOR A SHORTER LENS. THE SURGERY WENT WELL BUT THE REPORTER DID NOT KNOW THE CURRENT STATUS OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585093 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY MICL13.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention INJECTOR MODEL MSI-PF - LOT NUMBER UNK| CARTRIDGE MODEL SFC-45 FP - LOT NUMBER UNK| FOAM TIP PLUNGER MODEL FTP - LOT NUMBER UNK