BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2428570 · Received January 20, 2012

    Report

    Report Number
    2023826-2012-00057
    Event Type
    Injury
    Date Received
    January 20, 2012
    Report Date
    December 22, 2011
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: LENS WORK ORDER SEARCH MEDICAL REVIEW. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. MEDICAL REVIEW: REVIEW OF THIS FILE INDICATES THAT PATIENT DEVELOPED INCREASED IOP POST ICL IMPLANTATION WHICH REQUIRED MEDICATIONS FOR 3 MONTHS. THE SURGEON INDICATED THAT THE PATIENT HAS OCULAR HYPERTENSION HOWEVER IT IS UNKNOWN IF THE ICL CAUSED OR CONTRIBUTED TO THIS CONDITION. IN THE CLINICAL TRIALS FOR THE VISIAN ICL, ELEVATED IOP POSTOPERATIVELY >25MMHG DURING FOLLOW-UP OR AN INCREASE OF >10MMHG OVER PREOPERATIVE WAS NOTED IN 5 CASES (1.4 PERCENT) THROUGH 3 YEARS (ONLY 1 PERSISTED DURING LAST VISIT). ONLY 2 CASES (0.4 PERCENT) IN THE ENTIRE COHORT WERE DIAGNOSED WITH OCULAR HYPERTENSION AND STARTED ON PRESSURE LOWERING MEDICATIONS. CONCLUSIONS: (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND MEDICAL REVIEW, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS - MEDICAL REVIEW; RECEIVED ADD'L INFO THAT OCULAR HYPERTENSION WAS PRE-EXISTING THEREFORE IT COULD NOT HAVE BEEN CAUSED NOR CONTRIBUTED BY THE DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL REVIEW: OS: REPORTED BY A (B)(6) YEAR OLD PATIENT, DECREASE OF VISUAL ACUITY, DUE TO A CATARACT DEVELOPMENT, WAS OBSERVED AT THE CLINICAL FOLLOW-UP ALMOST FOUR YEARS AFTER ICL IMPLANTATION. ACCORDING TO THE PHYSICIAN, THE TYPE OF THE CATARACT WAS ANTERIOR SUBCAPSULAR WITH NO PROGRESSION AND VA WAS 20/30. THE LENS REMAINS IMPLANTED. EVEN THOUGH THE CATARACT WAS ATTRIBUTED TO THE DEVICE ("LOW VAULT") IT SHOULD BE NOTED THAT VISIAN ICL IS INDICATED FOR IMPLANTATION IN ADULTS 21-45 YEARS OF AGE AND AT THE TIME OF THE IMPLANTATION THE PATIENT WAS (B)(6) YEARS OLD, THEREFORE THERE IS INSUFFICIENT DATA TO SUPPORT IMPLANTATION IN SUCH PATIENTS. THE PATIENT FACTOR (AGE) CAUSED/CONTRIBUTED TO THE DEVELOPMENT OF A CATARACT SINCE THE LITERATURE REPORTS THAT 6-7% OF PATIENTS DEVELOP A CATARACT FOLLOWING ICL IMPLANTATION BUT ONLY IN 1-2% PROGRESS TO CLINICALLY SIGNIFICANT, ESPECIALLY IN HIGH MYOPES AND OLDER PATIENTS. THE PHYSICIAN REPORTED THE PATIENT WAS MEDICALLY TREATED FOR OCULAR HYPERTENSION/GLAUCOMA, IN 2010, POST ICL IMPLANTATION BUT THAT WAS CAUSED BY PATIENT PRE-EXISTING CONDITION (NOT DEVICE RELATED) AND THE ISSUE RESOLVED WITHOUT SEQUELAE. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND MEDICAL REVIEW, A SPECIFIC ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED. (B)(4). LENS REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD A MICL 12.6MM IMPLANTABLE COLLAMER LENS IMPLANTED IN THE LEFT EYE ON (B)(6) 2010. AS PART OF THE POST MARKET STUDY, THE PATIENT REPORTED HAVING OCULAR HYPERTENSION AND BEING PRESCRIBED EYE DROPS FOR AT LEAST 3 CONSECUTIVE MONTHS. THE DOCTOR'S OFFICE CONFIRMED THE INFORMATION THE PATIENT REPORTED. PATIENT'S LAST VISIT WAS ON (B)(6) 2011. ONGOING MONITORING. VA POST-TREATMENT 20/25. THE ICL REMAINS IMPLANTED.

    Description of Event or Problem · 1

    ADD'L INFO: OCULAR HYPERTENSION WAS NOTED PRE-OP.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: THE PATIENT REPORTED DEVELOPING A CATARACT AND HIGH PRESSURE AND GLAUCOMA. THE PHYSICIAN'S OFFICE WAS CONTACTED FOR FURTHER INFORMATION. THE PHYSICIAN REPORTED THE PATIENT LAST VISIT WAS ON (B)(6) /2014. THE PATIENT DEVELOPED A ANTERIOR SUBCAPSULAR CATARACT THAT WAS DIAGNOSIS ON (B)(6) 2012. THERE WAS LOW VAULT, THE ICL REMAINS IMPLANTED. THE CATARACT HAS NOT PROGRESSED AND VA POST-OP IS 20/30. PROGNOSIS IS GOOD. THE PHYSICIAN ALSO STATED THE PATIENT DID HAVE OCULAR HYPERTENSION/GLAUCOMA DIAGNOSED ON (B)(6) 2010. THE PATIENT WAS TREATED WITH MEDICATIONS AND IT HAS BEEN RESOLVED. PROGNOSIS IS GOOD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention