BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H-10

    MDR report key: 4880570 · Received June 30, 2015

    Report

    Report Number
    2023826-2015-00788
    Event Type
    Injury
    Date Received
    June 30, 2015
    Report Date
    June 1, 2015
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER MEDICAL REVIEW - REPORTEDLY, BY IMPLANTING SURGEON, THE PATIENT DEVELOPED RECURRENT PCO FOLLOWING YAG CAPSULOTOMY (3 TIMES) AFTER SINGLE-PIECE COLLAMER LENS IMPLANTATION. ACCORDING TO THE EMAIL CORRESPONDENCE BETWEEN IMPLANTING SURGEON AND KOL , DATED ON (B)(6) 2015, THAT WAS A KNOWN ISSUE THAT HAD A TENDENCY TO RESOLVE SPONTANEOUSLY OVER TIME. THE KOL FURTHER ADVISED SURGEON TO DISRUPT ANTERIOR HYALOID FACE IF VISUAL AXIS WAS INCLUDED. HE ALSO NOTED THAT PATIENTS WITH DIABETES AND INFLAMMATION WERE IN HIGH RISK GROUP. NO ALLEGED DEVICE CAUSALITY WITH THE EVENT. THE SERIOUSNESS IS BASED ON THE INFORMATION THAT YAG CAPSULOTOMY IS NOT SECONDARY SURGICALLY INTERVENTION PER ISO 11979-7. BASED ON THE COMPLAINT HISTORY AND MEDICAL REVIEW, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    COLLAMER®ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS. EXPIRATION DATE - UNKNOWN IMPLANT DATE: UNKNOWN. EVALUATION CONCLUSION: BASED ON THE INFORMATION PROVIDED , WE WERE UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE OF THE EVENT. (B)(4). LENS REMAINS IMPLANTED.

    Description of Event or Problem · 1

    THE SURGEON IMPLANTED A CC4204A COLLAMER SINGLE PIECE LENS AND REPORTED CAPSULAR CONTRACTION AND CORNEAL EDEMA. STAAR'S MEDICAL CONSULTANT INFORMED THE CUSTOMER "RECURRENT PCO AFTER YAG CAPSULOTOMY HAS BEEN REPORTED. DIABETES AND INFLAMMATION ARE RISK FACTORS. IT TENDS TO SPONTANEOUSLY RESOLVE OVER A PERIOD OF A FEW YEARS. IF IT IS AFFECTING THE VISUAL ACUITY A REPEAT CAPSULOTOMY BEING CAREFUL TO DISRUPT THE ANTERIOR HYALOID FACE FOLLOWED BY POSTOP STEROIDS SEEMS LIKE A REASONABLE OPTION". NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421041 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY CC4204A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1