BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POSTERIOR CHAMBER LENS

    MDR report key: 3505847 · Received November 20, 2013

    Report

    Report Number
    1119421-2013-01164
    Event Type
    Injury
    Date Received
    November 20, 2013
    Date of Event
    January 1, 2013
    Report Date
    October 28, 2013
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P840060
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE FOR THE REPORTED COMPLAINTS. NOT ENOUGH INFORMATION WAS PROVIDED FROM THE ACCOUNT FOR FURTHER INVESTIGATION. LUK ASW, YOUNG AL, CHENG LL. LONG-TERM OUTCOME OF SCLERAL FIXATED INTRAOCULAR LENS IMPLANTATION. BR J OPHTHALMOL 2013 97: 1308-11. ADDITIONAL INFORMATION IS NOT EXPECTED. (B)(4).

    Description of Event or Problem · 1

    IN A LITERATURE ARTICLE, THE AUTHORS REPORTED THE RESULTS OF A RETROSPECTIVE STUDY THAT REVIEWED WHETHER, IN THE ABSENCE OF CAPSULAR SUPPORT, SCLERAL-FIXATED INTRAOCULAR LENS (SFIOL) IMPLANTATION IS AN EFFECTIVE SURGICAL OPTION COMPARED TO THE USE OF NO-SURGICAL INTRAOCULAR LENSES (IOLS) OR ANTERIOR CHAMBER INTRAOCULAR LENSES (ACIOLS). IN THIS STUDY, THE AUTHORS ASSESSED THE LONG-TERM OUTCOME AND COMPLICATION PROFILE OF SCLERAL-FIXATED INTRAOCULAR LENS (SFIOL) IMPLANTATION. IN A COHORT OF CHINESE EYES, 104 EYES OF 99 PATIENTS WERE IDENTIFIED. THE AUTHORS REPORTED 25 OF 104 EYES HAD POSTOPERATIVE COMPLICATIONS. FOUR EYES HAD EXPOSED POLYPROPYLENE SUTURE KNOTS THAT REQUIRED SUTURE TRIMMING OR ROTATION WITHIN ONE YEAR. IN TWO EYES THE AUTHORS REPORTED, THE IOLS SUBLUXED. THE FIRST PATIENT EXPERIENCED OCULAR TRAUMA SEVEN YEARS POSTOPERATIVELY, WITH SUBSEQUENT PARS PLANA VITRECTOMY AND SFIOL RE-FIXATION. THE SECOND PATIENT DEVELOPED SUBLUXATION THE DAY AFTER IMPLANT SURGERY. THIS PATIENT HAD DEMENTIA AND UNKNOWN HISTORY OF ANY OCULAR TRAUMA. SFIOL REMOVAL AND RE-IMPLANTATION WAS PERFORMED DAY ONE, AND NO FURTHER COMPLICATIONS WERE NOTED. FIVE EYES WERE NOTED TO HAVE SIGNIFICANT CORNEAL EDEMA OR CORNEAL DECOMPENSATION POSTOPERATIVELY, HOWEVER, ALL FIVE HAD PREOPERATIVE RISK FACTORS: ONE EYE HAD A HISTORY OR FUCH'S DYSTROPHY AND LOW ENDOTHELIAL CELL (EDC) COUNT, TWO EYES HAD PREVIOUS VITREO-RETINAL SURGERY, ONE EYE HAD A HISTORY OR ACUTE ANGLE CLOSURE WITH MILD CORNEAL DECOMPENSATION AND LOW EDC COUNT, ONE EYE HAD A HISTORY OF PREVIOUS ANTERIOR CHAMBER IOL EXPLANATION FOLLOWING THE DEVELOPMENT OF HAPTIC PROTRUSION. HIGH INTRAOCULAR PRESSURE (IOP) THAT REQUIRED SURGICAL INTERVENTION OCCURRED IN THREE PATIENTS; ALL HAD A HISTORY OF TRAUMATIC CATARACT. TWO EYES HAD IRIDODIALYSIS AND PERIPHERAL ANTERIOR SYNECHIAE AND ONE HAD SIGNIFICANT ANGLE RECESSION. SIGNIFICANT POSTOPERATIVE ASTIGMATISM REQUIRING REFRACTIVE SURGERY WAS NOTED IN THREE EYES. ALL THREE HAD A PRIOR HISTORY OF OCULAR TRAUMA WHICH REQUIRED RUPTURED EYE REPAIR AND TRAUMATIC CATARACT SURGERY. LASER IN-SITU KERATOMILEUSIS CORRECTION WAS CARRIED OUT IN ONE EYE WITH ASTIGMATISM OF -7 DIOPTERS WHICH REDUCED THE ASTIGMATISM TO -3.5 DIOPTERS WITH A FINAL POSTOPERATIVE VISUAL ACUITY OF 20/200. ONE EYE UNDERWENT ASTIGMATIC KERATOTOMY WITH SUBSEQUENT REDUCTION OF ASTIGMATISM FROM -6 DIOPTERS TO -2.5 DIOPTERS AND LATEST VISUAL ACUITY OF 20/70. THE OTHER EYE HAD KNOWN PREOPERATIVE HIGH ASTIGMATISM OF -6 DIOPTERS, WHICH DID NOT IMPROVE FOLLOWING SFIOL IMPLANTATION AND COMPRESSION SUTURES, WITH LATEST ACUITY OF 18/200. RETINAL DETACHMENT OCCURRED IN ONE EYE AFTER OCULAR TRAUMA NINE MONTHS POSTOPERATIVELY AND REQUIRED VITREO-RETINAL SURGERY, WHICH WAS COMPLICATED BY BULLOUS KERATOPATHY AT A LATER STAGE, WITH THE MOST RECENT VISUAL ACUITY OF 20/200. CHOROIDAL DETACHMENT OCCURRED IN ONE EYE ON POSTOPERATIVE DAY ONE AND SPONTANEOUSLY RESOLVED WITH TWO WEEKS WITH A LATEST VISUAL ACUITY OF 20/50. THE AUTHORS REPORTED OF THE REMAINING SIX PATIENTS, TWO HAD AN UP-DRAWN PUPIL, ONE HAD A TILTED SFIOL, ONE HAD A REFRACTIVE SURPRISE, ONE HAD A VASCULAR OCCLUSION AND ONE HAD CYSTOID MACULAR EDEMA. OVERALL, 13 OF 104 EYES REQUIRED AN ADDITIONAL SURGICAL PROCEDURE POSTOPERATIVELY. NO FURTHER INFORMATION IS EXPECTED. THIS MEDICAL DEVICE REPORT INCLUDES ALL ADVERSE EVENTS REPORTED IN THIS LITERATURE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602284 POSTERIOR CHAMBER LENS INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON CZ70BD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R 10-0 NYLON POLYPROPYLENE SUTURES