BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H-10

    MDR report key: 4880286 · Received June 30, 2015

    Report

    Report Number
    2023826-2015-00785
    Event Type
    Injury
    Date Received
    June 30, 2015
    Date of Event
    March 27, 2015
    Report Date
    June 1, 2015
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS (ELASTIC®) WITH TORIC. (B)(6). EVALUATION CODES CONCLUSION (UNABLE TO CONFIRM) BASED ON THE INFORMATION PROVIDED, WE ARE UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE OF THE EVENT. THE LENS REMAINS IMPLANTED. (B)(4). LENS REMAINS IMPLANTED

    Additional Manufacturer Narrative · 1

    CUSTOMER CALLED BACK AND REPORTED THE LENS WAS IMPLANTED ON (B)(6) 2015 AND THE REFRACTIVE SURPRIZE WAS NOTED ON (B)(6) 2015. AFTER THE SURGEON CONSULTED WITH STAAR'S MEDICAL CONSULTANT, THE LENS WAS EXCHANGED FOR THE RECOMMENDED POWER AND THIS RESOLVED THE ISSUE. THE CUSTOMER PROVIDED THE SERIAL NUMBER OF THE LENS BUT DOES NOT RECALL WHAT HAPPEN TO IT. A LENS WORK ORDER SEARCH WAS PERFORMED AND REVEALED THERE WERE NO SIMILAR COMPLAINTS WITHIN THE WORK ORDER. MEDICAL REVIEW: REVIEW OF THE COMPLAINT FILE INDICATES THAT THE PATIENT'S IOL (AA4203TL, 27/3.5D) LENS IN THE RIGHT EYE (OD) WAS REMOVED AND EXCHANGED TO A DIFFERENT LENS (27D) TO ADDRESS THE REFRACTIVE SURPRISE NOTED ONE WEEK FOLLOWING THE SURGERY. THE ISSUE WAS RESOLVED. THE REFRACTION BEFORE LENS IMPLANTATION SURGERY WAS: S: +4.25 C: +2.5 A: 093, BCVA 20/30; K1=42.09@179, K2=44.42@89. AFTER THE INITIAL LENS IMPLANTATION SURGERY THE REFRACTION WAS: S: -1.0 C: +2.0 A:175, BCVA 20/20; LENS IS NOT AVAILABLE. ACCORDING TO THE DFU (DIRECTION FOR USE), THE EFFECTIVENESS OF THE TORIC LENS IN CORRECTING ASTIGMATISM CAN BE REDUCED WHEN THE DEVIATION BETWEEN THE LONGITUDINAL AXIS OF THE LENS AND THE STEEP KERATOMETRIC READING IS MORE THAN THAN30 TO 40 DEGREES AFTER THE SURGERY. SUCH AXIS DEVIATION CAN BE THE CONSEQUENCES OF INACCURATE KERATOMETRIC MEASUREMENT OR DETERMINATION,INACCURATE ORIENTATION OF THE LENS AXIS AT THE TIME OF SURGERY, SURGICAL TECHNIQUE INDUCED ASTIGMATISM AND /OR PHYSICAL ROTATION OR DISLOCATION OF THE LENS AFTER IMPLANTATION. BASED ON THE PATIENT INFORMATION AND CONSULTANT DR.(B)(6) CALCULATION THAT ROTATION OF THE TORIC LENS COUNTER CLOCKWISE TO 105 DEGREES WILL DECREASE THE ASTIGMATISM TO 0.96D, IT IS MOSTLY LIKELY THE SURGICAL FACTOR AND/OR PATIENT FACTOR AFFECTING THE POSITION OF LENS CONTRIBUTE TO THE EVENT. IT IS UNLIKELY THE MEDICAL DEVICE IS THE DIRECT REASON FOR THE EVENT. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS IS A RESUBMISSION TO CORRECT MFR # FOR SUPP#2 IN WHICH THE MFR NUMBER WAS REPORTED INCORRECT. CLAIM# (B)(4).

    Additional Manufacturer Narrative · 1

    THE FOLLOWING STATEMENT SHOULD HAVE BEEN ADDED IN SUPPLEMENTAL #2: DEVICE HISTORY RECORD (DHR) REVIEW: REVIEW OF THE MANUFACTURING, INSPECTION, AND PACKAGING PROCESS CONCLUDED THERE WAS NOTHING FOUND TO SUGGEST A CONTRIBUTORY FACTOR TO THIS COMPLAINT. CLAIM# (B)(4).

    Description of Event or Problem · 1

    THE SURGEON REPORTED COMPLEX REFRACTIVE SURPRISE AND AFTER IMPLANTATION OF A AA4203TL SILICONE SINGLE LENS. STAAR'S MEDICAL CONSULTANT ADVISED PROVIDED FEEDBACK TO THE CUSTOMER INDICATING THERE SEEMS TO BE A SIGNIFICANT POSTERIOR CORNEAL ASTIGAMATISM AND RECOMMENDED REDUCING THE ASTIGMATISM A BIT FURTHER WITH AN IOL EXCHANGE TO A NON TORIC IOL. NO FURTHER INFORMATION PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422536 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AA4203TF N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR