BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOT AVAILABLE

    MDR report key: 5888510 · Received August 19, 2016

    Report

    Report Number
    9611165-2016-00041
    Event Type
    Injury
    Date Received
    August 19, 2016
    Report Date
    August 19, 2016
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE (B)(4) HAS BEEN ALLOCATED TO THIS CASE BY RAYNER. THE HEALTHCARE FACILITY REPORTS THAT IOL OPACIFICATION WAS OBSERVED IN THE POST-OPERATIVE PERIOD NECESSITATING EXPLANTATION OF THE IOL. AT THIS TIME, NO FURTHER INFORMATION ON THE REPORT OF IOL OPACIFICATION IS AVAILABLE TO RAYNER. RAYNER IS CONTINUING TO FOLLOW UP WITH THE HEALTHCARE FACILITY TO OBTAIN ADDITIONAL INFORMATION TO FACILITATE FURTHER INVESTIGATION OF THIS EVENT. THE FOLLOWING POTENTIAL CAUSES HAVE BEEN DISCUSSED IN THE LITERATURE: MULTIFACTORIAL, REPEATED EXPOSURE TO INTRACAMERAL AIR, RAISED INTRAOCULAR PRESSURE, MAY BE MORE LIKELY IN COMPLICATED, TRAUMATISED EYES, AS A RESULT OF DIRECT CONTACT BETWEEN THE IOL SURFACE AND THE EXOGENOUS GAS OR SUBSTANCE, A METABOLIC CHANGE IN THE ANTERIOR CHAMBER DUE TO THE PRESENCE OF THE EXOGENOUS GAS/SUBSTANCE IN THE EYE OR AN EXACERBATED INFLAMMATORY REACTION AFTER MULTIPLE SURGICAL PROCEDURES, TRAUMA OF REPEAT SURGERY INVOLVED IN RE-BUBBLING POTENTIALLY DISRUPTING THE BLOOD AQUEOUS BARRIER, INCREASING THE CONCENTRATION OF CALCIUM IONS. REFERENCES: WALKER NJ ET AL. CALCIFICATION OF HYDROPHILIC ACRYLIC INTRAOCULAR LENSES IN COMBINED PHACOVITRECTOMY SURGERY. J REFRACT SURG 2010; 36:1427-1431. P. MOTRGAN WARREN ET AL. INTRAOCULAR LENS OPACIFICATION AFTER DESCEMETS' STRIPPING AUTOMATED ENDOTHELIAL KERATOPLASTY (DSAEK) (2014 ESCRS POSTER PRESENTATION) . A DHITAL ET AL. CALCIFICATION IN HYDROPHILIC INTRAOCULAR LENSES ASSOCIATED WITH INJECTION OF INTRAOCULAR GAS. AMERICAN JOURNAL OF OPHTHALMOLOGY: 2012; JUN;153(6):1154-60. L WERNER ET AL LOCALISED OPACIFICATION OF HYDROPHILIC ACRYLIC INTRAOCULAR LENSES AFTER PROCEDURES USING INTRACAMERAL INJECTION OF AIR OR GAS: 2014: VOL 41, ISSUE 1, P199-207. DEVICE NOT RETURNED TO MANUFACTURER

    Description of Event or Problem · 1

    ON 9TH AUGUST 2016, RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM A (B)(6) HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF AN UNSPECIFIED RAYNER IOL MODEL. THE EVENT DESCRIPTION PROVIDED STATES THAT IOL OPACIFICATION WAS OBSERVED ON AN UNKNOWN DATE AFTER DSAEK SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541576 NOT AVAILABLE NOT AVAILABLE HQL RAYNER INTRAOCULAR LENSES LIMITED NOT AVAILABLE NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention