BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVO/EVO+ VISIAN IMPLANTABLE COLLAMER LENS

    MDR report key: 23176424 · Received September 29, 2025

    Report

    Report Number
    2023826-2025-01487
    Event Type
    Injury
    Date Received
    September 29, 2025
    Report Date
    September 29, 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: HEALTH EFFECT- IMPACT CODE: (F): '4644' SHOULD BE REMOVED AND '4614' SHOULD BE ADDED. B5.- AN ARTICLE WAS PUBLISHED IN RESEARCH SQUARE CITING A CASE STUDY OF "LONG TERM OBSERVATION OF GLARE AND DYNAMIC PUPIL AFTER EVO ICL FOR MYOPIA". THE PATIENT(S) EXPERIENCED ENDOTHELIAL CELL LOSS. GLARE. PUPIL IMPAIRMENT. THE ARTICLE REPORTED, 'ACCORDING TO THE RESULTS OF THE QUESTIONNAIRE, 72.7% (16/22) OF THE PATIENTS REPORTED GLARE SYMPTOMS AND 27.3% (6/22) REPORTED GLARE SYMPTOMS DISAPPERARED AFTER 5 YEARS OF ICL IMPLANTATION, WITH 13.6% (3/22) OF THEM REPORTING FREQUENT SYMPTOMS. NONE OF THE PATIENTS, HOWEVER, REPORTED EXPERIENCING SEVERE GLARE SYMPTOMS. FURTHERMORE, GLARE BOTHERSOMENESS WERE REPORTED BY 31.8% (7/22) OF THE PATIENTS BUT THESE BOTHERSOMENESS WERE ALL MILD IN NATURE. ADDITIONALLY, 18.2% (4/22) OF PATIENTS REPORTED MILD IMPAIRMENT WHEN DRIVING AT NIGHT (CITY DRIVING, SPEED LIMIT 80 KM/H)." IT WAS ALSO REPORTED, 'A SIGNIFICANT REDUCTION IN ECD WAS NOTICED BOTH AT FIVE YEARS POSTOPERATIVELY COMPARED TO PREOPERATIVELY AND AT THREE MONTHS POSTOPERATIVELY (BOTH P< 0.05). THE MEAN RATE OF ECD LOSS WAS 8.77% AT FIVE YEARS AFTER ICL'. IN ADDITION, 'FIVE YEARS AFTER SURGERY, THE AVERAGE PUPIL DIAMETER WAS SIGNIFICANTLY SMALLER THAN THE PREOPERATIVE VALUES (P= 0.016), BUT NO SIGNIFICANT CHANGES IN AVERAGE PUPIL DIAMETER WERE OBSERVED AT ONE WEEK, ONE MONTH, AND THREE MONTHS AFTER SURGERY'. THE AUTHORS CONCLUDED THAT 'EVO ICL IS SAFE AND EFFECTIVE IN CORRECTING MYOPIA. POST-OPERATIVE GLARE IS RELATED TO THE PUPIL DILATION VELOCITY, MAXIMUM PUPIL DIAMETER, AND DECREASES OVER TIME. MOST PATIENTS HAVE NO GLARE BOTHERSOMENESS IN THE LONG TERM, SOME PATIENTS MAY EVEN HAVE THEIR GLARE SYMPTOMS DISAPPEAR. ONLY A FEW PATIENTS EXPERIENCE SLIGHT INTERFERENCE WHILE NIGHTTIME DRIVING'. CLAIM# (B)(4).

    Additional Manufacturer Narrative · 0

    H6-HEALTH EFFECT- CLINICAL CODE: "4581- ENDOTHELIAL CELL LOSS AND PUPIL IMPAIRMENT ' SHOULD BE ADDED. CLAIM# (B)(4)

    Description of Event or Problem · 0

    AN ARTICLE WAS PUBLISHED IN RESEARCH SQUARE CITING ]A CASE STUDY OF "LONG TERM OBSERVATION OF GLARE AND DYNAMIC PUPIL AFTER EVO ICL FOR MYOPIA". THE PATIENT(S) EXPERIENCED ENDOTHELIAL CELL LOSS. GLARE. PUPIL IMPAIRMENT AND MEDICATION ADMINISTERED. THE ARTICLE REPORTED, "ACCORDING TO THE RESULTS OF THE QUESTIONNAIRE, 72.7% (16/22) OF THE PATIENTS REPORTED GLARE SYMPTOMS AND 27.3% (6/22) REPORTED GLARE SYMPTOMS DISAPPEARED AFTER 5 YEARS OF ICL IMPLANTATION, WITH 13.6% (3/22) OF THEM REPORTING FREQUENT SYMPTOMS. NONE OF THE PATIENTS, HOWEVER, REPORTED EXPERIENCING SEVERE GLARE SYMPTOMS. FURTHERMORE, GLARE BOTHERSOMENESS WERE REPORTED BY 31.8% (7/22) OF THE PATIENTS BUT THESE BOTHERSOMENESS WERE ALL MILD IN NATURE. ADDITIONALLY, 18.2% (4/22) OF PATIENTS REPORTED MILD IMPAIRMENT WHEN DRIVING AT NIGHT (CITY DRIVING, SPEED LIMIT 80 KM/H). (TABLE 2 AND FIGURE 3)." IT WAS ALSO REPORTED, "THE AMPLITUDE OF CONTRACTION WAS SIGNIFICANTLY REDUCED AT 1 WEEK, 1 MONTH, AND 3 MONTHS POSTOPERATIVELY COMPARED TO THE PREOPERATIVE PERIOD" AND "THE PUPIL CONTRACTION VELOCITY WAS SIGNIFICANTLY LOWER AT ALL POSTOPERATIVE TIME POINTS WHEN COMPARED TO THE PREOPERATIVE PERIOD". IN ADDITION, "PUPIL DILATION VELOCITIES WERE SIGNIFICANTLY LOWER FOR THE FIRST WEEK, MONTH, AND THREE MONTHS POSTOPERATIVELY WHEN COMPARED TO THE PREOPERATIVE PERIOD (P<0.01). HOWEVER, THE DILATION VELOCITIES WERE MOSTLY RESTORED FIVE YEARS AFTER SURGERY (P>0.05). AFTER 5 YEARS OF SURGERY, THE MAXIMUM PUPIL DIAMETER SIGNIFICANTLY DECREASED IN COMPARISON TO THE MEASUREMENTS TAKEN BEFORE AND ONE WEEK AFTER THE SURGERY, FIVE YEARS AFTER SURGERY, THE AVERAGE PUPIL DIAMETER WAS SIGNIFICANTLY SMALLER THAN THE PREOPERATIVE VALUES (P= 0.016), BUT NO SIGNIFICANT CHANGES IN AVERAGE PUPIL DIAMETER WERE OBSERVED AT ONE WEEK, ONE MONTH, AND THREE MONTHS AFTER SURGERY. HOWEVER, A SIGNIFICANT REDUCTIONIN ECD WAS NOTICED BOTH AT FIVE YEARS POSTOPERATIVELY COMPARED TO PREOPERATIVELY AND AT THREE MONTHS POSTOPERATIVELY (BOTH P< 0.05). THE MEAN RATE OF ECD LOSS WAS 8.77% AT FIVE YEARS AFTER ICL.". ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478317 EVO/EVO+ VISIAN IMPLANTABLE COLLAMER LENS PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other