BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVO/EVO+ VISIAN IMPLANTABLE COLLAMER LENS

    MDR report key: 21911882 · Received April 25, 2025

    Report

    Report Number
    2023826-2025-00610
    Event Type
    Injury
    Date Received
    April 25, 2025
    Report Date
    April 25, 2025
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: B5.- AN ARTICLE WAS PUBLISHED IN ASCRS ANNUAL MEETING CITING SURGICAL COMPLICATIONS A CASE STUDY OF "ONE STEP ONE DAY SEQUENTIAL BILATERAL VERSUS STANDARD PROCESS IN ICL IMPLANTATION: A NON INFERIORITY RANDOMIZED CLINICAL TRIAL". THIS STUDY INCLUDED RANDOMIZED COMPARATIVE SINGLE MASKED CLINICAL TRIAL' OF 530 EYES OF 260 PATIENTS WITH THE INTENTION OF EXAMINING THE EFFICACY AND SAFETY OF ONE STEP WITHOUT VISCOELASTIC AGENT'. THE PATIENT(S) EXPERIENCED ELEVATED IOP. REPORTEDLY '6 PATIENTS EXPERIENCED ICL EXCHANGE BECAUSE OF ABNORMAL VAULT' AND '4 PATIENTS EXPERIENCED HIGH IOP IN THE IMMEDIATE POST OP PERIOD WHICH WAS RESOLVED WITHOUT INCIDENT'. THE AUTHOR STATED THAT NOTABLY, THESE CHANGES DID NOT AFFECT THE SAFETY EFFICACY AND PREDICTABILITY OF POST OP RECOVERY AT 12 MONTHS'. THE AUTHORS CONCLUDED THAT THE RESULTS FROM THIS RANDOMIZED TRIAL SUGGEST THAT ONE STEP IN ONE DAY TECHNIQUE FOR EVO-ICL PRODUCED PROMISING CLINICAL RESULTS IN TERMS OF SAFETY, EFFICACY, AND CONVENIENCE AT 3 AND 12 MONTHS OF FOLLOW-UP'. D10.- "INJECTOR MODEL: MSI-PF; LOT# UNK ; CARTRIDGE MODEL: SFC-45: LOT# UNK ; FOAM TIP PLUNGER (FTP); LOT# UNK" SHOULD BE REMOVED. H6-HEALTH EFFECT- CLINICAL CODE: "4581-ENDOTHELIAL CELL DENSITY (ECO) AND CORNEAL DENSITOMETRY VALUES." SHOULD BE REMOVED. CLAIM# (B)(4).

    Additional Manufacturer Narrative · 0

    D1- UNABLE TO LEAVE BLANK. H6-HEALTH EFFECT- CLINICAL CODE: "4581-ENDOTHELIAL CELL DENSITY (ECD) AND CORNEAL DENSITOMETRY VALUES. " SHOULD BE ADDED. H11- MANUFACTURER NARRATIVE: SECONDARY SURGICAL INTERVENTION TO REMOVE/REPLACE/REPOSITION THE LENS IS IDENTIFIED IN THE LABELING AS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING ICL IMPLANTATION. CLAIM#: (B)(4).

    Description of Event or Problem · 0

    AN ARTICLE WAS PUBLISHED IN ASCRS ANNUAL MEETING CITING SURGICAL COMPLICATIONS A CASE STUDY OF "ONE STEP ONE DAY SEQUENTIAL BILATERAL VERSUS STANDARD PROCESS IN ICL IMPLANTATION: A NON-INFERIORITY RANDOMIZED CLINICAL TRIAL" THIS STUDY INCLUDED "TOTAL OF 268 PATIENTS [530 EYES] WERE RANDOMLY DISTRIBUTED INTO OIO GROUP (270 EYES) AND SDP GROUP (260 EYES). CONSECUTIVE ELIGIBLE MYOPIA AND MYOPIC ASTIGMATISM PATIENTS WERE RANDOMIZED TO UNDERGO EVO-ICL.". THE PATIENT(S) EXPERIENCED AM ABNORMAL VAULT, ELEVATED IOP, ENDOTHELIAL CELL DENSITY (ECD), AND CORNEAL DENSITOMETRY VALUES. REPORTEDLY "THE PATIENTS WERE RANDOMIZED TO EITHER OIO TECHNIQUE OR STANDARD PROCESS (SDP) ALONE, WITH TWO INCISION AND SEPARATING SEQUENTIAL BILATERAL EVO-ICL ON DIFFERENT DAYS. THE MAIN OUTCOME WERE INTRA- AND POSTOPERATIVE COMPLICATIONS. SECONDARY OUTCOMES WERE REFRACTIVE OUTCOMES, INTRAOCULAR PRESSURE (IOP), ENDOTHELIAL CELL DENSITY (ECD), CORNEAL DENSITOMETRY VALUES (CDS) AND VAULT AT 3 AND 12 MONTHS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390340 EVO/EVO+ VISIAN IMPLANTABLE COLLAMER LENS PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention CARTRIDGE MODEL-SFC-45, LOT#-UNK.| FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK.| INJECTOR MODEL-MSI-PF, LOT#-UNK.