BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 2050789 · Received April 1, 2011

    Report

    Report Number
    2023826-2011-00280
    Event Type
    Injury
    Date Received
    April 1, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 8, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION METHOD: WORK ORDER SEARCH. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND THERE WERE NO SIMILAR COMPLAINTS FOUND. CONCLUSION: NO CONCLUSION CAN BE DRAWN. BASED ON THE COMPLAINT HISTORY AND WORK ORDER SEARCH, WE WERE UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE OF THE EVENT. (B)(4).

    Additional Manufacturer Narrative · 1

    THE SCRUB TECH ON THIS CASE CALLED BACK AND STATED THE EYE WAS IN GOOD CONDITION PRIOR SURGERY AND WHEN THE LENS WAS INSERTED THE CAPSULE TORE AND THE LENS COLLAPSED IN THE EYE. THE SURGEON RETRIEVED THE LENS AND PERFORMED A VITRECTOMY. AN ACL WAS IMPLANTED. THE CAUSE OF THE EVENT REMAINS UNKNOWN. EVALUATION RESULTS: VISUAL INSPECTION OF THE RETURNED LENS SHOWED EVIDENCE OF A CLEAR SURGICAL RESIDUE, HOWEVER, THERE WAS NO VISIBLE DAMAGE TO THE LENS. BOTH SIDES OF THE OPTIC/ HAPTIC WERE CHECKED FOR ROUGH/SHARP EDGES AND EDGES WERE FOUND TO BE ACCEPTABLE.

    Description of Event or Problem · 1

    THE REPORTER STATED THE AA4203TL SILICONE SINGLE PIECE LENS WAS IMPLANTED AND THE CAPSULE BROKE. FELL BACK AND THE IOL HAD TO BE REMOVED. A VITRECTOMY WAS NEEDED. ANOTHER LENS WAS IMPLANTED INTO THE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED. IF ADDITIONAL INFORMATION IS OBTAINED A SUPPLEMENTAL MEDWATCH FORM WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AA4203TL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention CARTRIDGE: MODEL UNKNOWN, LOT # UNKNOWN| INJECTOR: MODEL UNKNOWN, LOT # UNKNOWN| INJECTOR: MODEL UNKNOWN, LOT # UNKNOWN| CARTRIDGE: MODEL UNKNOWN, LOT # UNKNOWN