BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 18602470 · Received January 29, 2024

    Report

    Report Number
    2023826-2024-00188
    Event Type
    Injury
    Date Received
    January 29, 2024
    Date of Event
    January 1, 2024
    Report Date
    January 1, 2024
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    UDI-DI
    00841542121149
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A4: UNK. A5: UNK. D6B: NA. H6: HEALTH IMPACT - ADDITIONAL SURGERY: 4625 - AC WASHOUT. H6: HEALTH EFFECT IMPACT CODE - MEDICATION REQUIRED: 4644 - INTRACAMERAL MOXIFLOXACIN; PREDNISOLONE ACETATE; FORTIFIED VANCOMYCIN/TOBRAMYCIN; PRED-MOXI-BROM. H6 - WORK ORDER SEARCH: NO SIMILAR COMPLAINT WAS REPORTED FOR UNITS WITHIN THE SAME LOT. CLAIM # (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H6 TYPE OF INVESTIGATION 3331 DEVICE HISTORY RECORD (DHR) REVIEW: BASED ON THE RESULTS OF THE INVESTIGATION, ALL RELEASED DEVICES FROM THE ASSOCIATED WORK ORDER(S), INCLUDING THE SUSPECTED DEVICE, HAVE BEEN MANUFACTURED WITHIN ESTABLISHED PROCESS PARAMETERS AND THERE IS NO INDICATION THAT THE MANUFACTURING AND PROCESSING OF THE DEVICE CONTRIBUTED TO THE COMPLAINT ISSUE. (B)(4).

    Description of Event or Problem · 0

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VTICMO13.2 IMPLANTABLE COLLAMER LENS -16.50/+1.50/105 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT`S RIGHT EYE (OD) ON (B)(6) 2023. ON THE (B)(6) 2024, INFLAMMATION WAS DIAGNOSED (EYE WAS RED AND PAINFUL). ADDITIONAL DIAGNOSTICS WERE PERFORMED SUCH AS MACULAR OCT AND VITREOUS CULTURES (NEGATIVE). SUBSEQUENT TREATMENTS WERE: AC WASHOUT, RETINA SURGEONS INJECTED ANTIBIOTICS. WITH PRESCRIPTION OF ADDITIONAL STEROIDS AND ANTIBIOTICS, BY (B)(6) 2024 ISSUES RESOLVED, EYE WAS WHITE AND QUIET, NEGATIVE SEIDEL TEST. ACCORDING TO THE SURGEON THE CAUSE OF THE EVENT WAS DUE TO A MEDICAL TRAUMA, DIFFICULT CASE; THE PUPIL WOULD NOT DILATE AND THE IRIS WAS MANIPULATED MORE THAN NORMAL. THE SURGEON INDICATES THIS WAS A CASE OF INFLAMMATION AND NOT INFECTION. THE LAST INFORMATION OBTAINED ON 23-JAN-2024 WAS STATING THAT PATIENT CURRENT POST-OP PROTOCOL WAS PRED-MOXI-BROM TWICE A DAY. THE LENS REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1033136 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICMO13.2 NA 00841542121149

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Male Required Intervention UNK.