BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H10

    MDR report key: 8798420 · Received July 17, 2019

    Report

    Report Number
    2023826-2019-01213
    Event Type
    Injury
    Date Received
    July 17, 2019
    Report Date
    June 20, 2019
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT CODE: 2692 TO 3191: PREVIOUS CODE NOT APPLICABLE, IOL IN AC. CLAIM#: (B)(4).

    Additional Manufacturer Narrative · 0

    B5- THE REPORTER INDICATED THAT A CQ2015A INTRAOCULAR LENS WAS IMPLANTED INTO THE PATIENTS EYE IN 2001. SURGEON REPORTED THAT "AFTER 18 YEARS PC IOL SUBLUXES INTO AC BECAUSE HAPTIC BROKE." REPORTEDLY NOTED BY SURGEON; "PATIENT GAVE HISTORY OF TRAUMA 1 YEAR AGO IN AIRPLANE; WHERE LUGGAGE HIT EYE BUT MAKES NO SENSE THAT SUCH A INCIDENT WOULD AMPUTATE HAPTIC." SURGEON WILL TAKE PATIENT BACK TO SURGERY TO REMOVE DAMAGED IOL; DO VITRECTOMY PUT 2RY (SECONDARY) IOL. SURGEON REPORTS "MEDICAL RECORDS ARE 15 YRS. OLD SO NOT AVAILABLE. PATIENT IN NO DISTRESS; IOL PARTIALLY IN AC." THE LENS WAS EXCHANGED ON (B)(6) 2019. PATIENT DOING WELL. CLAIM# (B)(4).

    Additional Manufacturer Narrative · 0

    EXPLANT DATE: UNK . PATIENT CODE 3191: SECONDARY SURGICAL INTERVENTION; EXPLANT. CLAIM#: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. EXPLANT DATE: (B)(6) 2019. PATIENT CODE 3191: SECONDARY SURGICAL INTERVENTION EXCHANGE. (B)(4).

    Additional Manufacturer Narrative · 1

    SERIAL NUMBER, EXPIRATION DATE, UNIQUE IDENTIFIER (UID) NUMBER: UNK. BRAND NAME: COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULAR LENS. IMPLANTED DATE: 2001. CLAIM # (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT A CQ2015A, INTRAOCULAR LENS WAS IMPLANTED INTO PATIENT'S EYE IN 2001. SURGEON REPORTED THAT "AFTER 18 YEARS PC IOL SUBLUXES INTO AC BECAUSE HAPTIC BROKE. REPORTEDLY NOTED BY SURGEON, "PATIENT GAVE HISTORY OF TRAUMA 1 YEAR AGO IN AIRPLANE, WHERE LUGGAGE HIT EYE. BUT MAKES NO SENSE THAT SUCH INCIDENT WOULD AMPUTATE HAPTIC." SURGEON WILL TAKE PATIENT BACK TO SURGERY, REMOVE DAMAGED IOL, DO VITRECTOMY, PUT 2RY (SECONDARY) IOL. SURGEON REPORTS "MEDICAL RECORDS ARE OVER 15 YRS OLD SO NOT AVAILABLE. PATIENT IN NO DISTRESS, IOL PARTIALLY IN AC." IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592583 SEE H10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY CQ2015A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R