BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H-10

    MDR report key: 4252253 · Received November 14, 2014

    Report

    Report Number
    2023826-2014-00984
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    September 17, 2014
    Report Date
    October 15, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS (ELASTIC®) WITH TORIC OPTIC. (B)(4) - VITREOUS FLUID, LOSS OF; VITRECTOMY; CORNEAL EDEMA. NO KNOWN DEVICE PROBLEM. EVALUATION METHOD: WORK ORDER SEARCH. RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT BOTH HAPTICS AND PIECE OF OPTIC IS TORN OFF AND MISSING. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINT WAS FOUND. CONCLUSION: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND THE EVALUATION OF THE RETURNED PRODUCT, THE ROOT CAUSE OF LENS TEAR WAS LOADING ERROR. THE ADVERSE EVENT WAS DUE TO THE REMOVAL OF THE LENS BUT WAS NOT DEVICE RELATED. (B)(6).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: A DESCEMET'S STRIPPING EPITHELIAL KERATOPLASTY (DSEK) PROCEDURE AND A CORNEAL TRANSPLANT WAS PERFORMED BY ANOTHER PHYSICIAN AT A LATER DATE. METHOD: MEDICAL REVIEW. RESULTS: MEDICAL REVIEW: OS: REPORTEDLY INTRAOPERATIVE LENS (SINGLE-PIECE SILICON WITH TORIC OPTIC) REMOVAL WAS PERFORMED TO ADDRESS OPTIC DAMAGE CAUSED BY USER ERROR (IMPROPER LOADING BY TECHNICIAN). DURING IOL REMOVAL INTRAOPERATIVE COMPLICATIONS OCCURRED: ZONULES WERE COMPROMISED; THERE WAS A VITREOUS LOSS AND SUBSEQUENT VITRECTOMY. EYE WAS LEFT APHAKIC. THE PATIENT WAS REFERRED TO CORNEA SPECIALIST FOR FURTHER TREATMENT OF PERSISTENT CORNEAL SWELLING WHICH RESULTED IN DSEK AND CORNEAL TRANSPLANT ON A LATER SURGERY DATE. ACCORDING TO THE SURGEON THE MOST LIKELY CAUSE OF THE LENS DAMAGE WAS USER ERROR AND ADVERSE EVENTS WERE CONSEQUENCES OF DAMAGED IOL REMOVAL. DFU INSTRUCTS PHYSICIANS UNDER "INSTRUCTION FOR USE IOL PREPARATION AND USAGE" HOW TO INSPECT THE LENS PRIOR TO IMPLANTATION IN ORDER TO AVOID LENS DAMAGE. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, MEDICAL REVIEW AND THE EVALUATION OF THE RETURNED PRODUCT, IT WAS DETERMINED THAT THE ROOT CAUSE OF THIS INCIDENT WAS USER ERROR AND CONSEQUENCES OF DAMAGED IOL REMOVAL. (B)(4).

    Description of Event or Problem · 1

    THE SURGEON REPORTED A AA4203TF SILICONE SINGLE PIECE LENS WITH TORIC OPTIC WAS INSERTED INTO THE PATIENT'S LEFT EYE. THE OPTIC TORE DURING INSERTION INTO THE EYE. THE CAUSE OF OPTIC TEAR WAS DUE TO LOADING ERROR BY THE TECH. REMOVAL OF THE LENS FROM THE EYE WAS DIFFICULT BECAUSE THE ZONULES WERE DENSE. HE ATTEMPTED TO REMOVE THE LENS WHOLE AND ENLARGED THE INCISION. FOUND IT DIFFICULT TO REMOVE, THE ZONULES WERE COMPROMISED AND HE DECIDED TO CUT THE LENS IN THREE PIECES TO REMOVE FROM EYE. THE LENS WAS REMOVED AND THERE WAS VITREOUS LOSS AND A ANTERIOR VITRECTOMY WAS PERFORMED. THERE WAS CORNEAL SWELLING AND PATIENT WAS REFERRED TO A CORNEAL SPECIALIST. NO LENS WAS IMPLANTED. THE PATIENT IS APHAKIA. NO SUTURE WAS USED. THE PHYSICIAN SAW THE PATIENT ON (B)(6) 2014 AND THERE WAS STILL SWELLING OF THE CORNEAL. THE PHYSICIAN IS GOING TO WAIT AND SEE IF THE SWELLING WILL GOES DOWN AND TO BE ABLE TO IMPLANT A LENS. THE PHYSICIAN STATED THIS INCIDENT WAS NOT CAUSED BY THE STAAR LENS. LENS TEAR WAS DUE TO LOADING ERROR AND REMOVAL OF TORN LENS WAS THE CAUSE OF ADVERSE EVENT. I WILL FOLLOW-UP REGARDING THE PATIENT'S CONDITION AND SUPPLEMENTAL WIL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737322 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AA4203TF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention INJECTOR MODEL AND LOT NUMBER - UNK| CARTRIDGE MODEL AND LOT NUMBER - UNK