BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H-10

    MDR report key: 4183151 · Received October 17, 2014

    Report

    Report Number
    2023826-2014-00839
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 17, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PT WEIGHT: UNK. BRAND NAME: SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS (ELASTIC®) WITH TORIC OPTIC. (B)(4). METHOD: LENS WORK ORDER SEARCH. RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND MOST OF PLATE HAPTIC AND PIECES OF OPTIC TORN OFF AND MISSING. A SMALL PIECE OF ONE HAPTIC TORN OFF AND MISSING. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE ON PRODUCT. A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINT WAS FOUND. CONCLUSIONS: (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF CAPSULE TEAR COULD NOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY RECORD REVIEW. RESULTS: DEVICE HISTORY RECORD REVIEW: REVIEW OF THE COMPLAINT FILE, DEVICE HISTORY RECORD AND PERFORMING A ROOT CAUSE ANALYSIS, THE ROOT CAUSE IS NOT LIKELY RELATED TO THE MANUFACTURING PROCESS OF THE LENS, BUT THERE IS NO DIRECT EVIDENCE THAT LEADS TO THE ROOT CAUSE OF THIS COMPLAINT. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, DEVICE HISTORY REPORT REVIEW AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    METHOD: MEDICAL REVIEW. RESULTS: MEDICAL REVIEW: OD: REPORTEDLY INTRAOPERATIVE LENS REMOVAL (SINGLE-PIECE STAAR IOL WITH TORIC OPTIC) WAS PERFORMED TO ADDRESS LENS DAMAGE THAT WAS NOTED UPON INSERTION. ACCORDING TO THE REPORT THE MOST LIKELY CAUSE OF THE LENS DAMAGE WAS USER ERROR (SHARP FORCEPS THAT TECHNICIAN USED DURING LOADING). ANOTHER LENS OF DIFFERENT MANUFACTURER WAS IMPLANTED IN THE SULCUS SINCE THERE WAS A CAPSULAR TEAR. THE CAUSE OF CAPSULAR TEAR WAS NOT ATTRIBUTED TO THE DAMAGED LENS REMOVAL AND REMAINED UNKNOWN. NO REPORTED POSTOPERATIVE SEQUELAE. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, DEVICE HISTORY RECORD REVIEW, MEDICAL REVIEW AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF CAPSULE TEAR COULD NOT BE DETERMINED. THE LENS WAS DAMAGED DUE TO USER ERROR. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED A AA4203TL SILICONE SINGLE PIECE LENS WITH TORIC OPTIC INTO THE PATIENT'S RIGHT EYE ON (B)(6) 2014. WHEN THE LENS WAS INJECTED INTO THE EYE THE LENS TORE. THE PHYSICIAN CUT THE LENS TO REMOVE FROM EYE. A CAPSULE TEAR WAS NOTED. THE PHYSICIAN IMPLANTED A SULCUS BASED LENS AND THE INCISION WAS SUTURED. THE TECHNICIAN USED SHARP FORCEPS TO LOAD THE LENS AND TORE THE LENS DURING LOADING. THE CAUSE OF THE CAPSULE TEAR IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660636 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AA4203TL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention CARTRIDGE MODEL AND LOT NUMBER - UNK| INJECTOR MODEL AND LOT NUMBER - UNK