BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ NATURAL SINGLEPIECE IOL

    MDR report key: 4935190 · Received July 23, 2015

    Report

    Report Number
    9612169-2015-00560
    Event Type
    Injury
    Date Received
    July 23, 2015
    Date of Event
    March 18, 2015
    Report Date
    November 24, 2015
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE FOR THE REPORTED COMPLAINT APPEARS TO BE A COINCIDENTAL EVENT THAT WAS UNRELATED TO THE IOL AS PER THE REPORTER, THE DEVICE DID NOT CAUSE/CONTRIBUTE TO THE EVENT. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PICTURES WERE PROVIDED. THE REVIEW OF TWO RETRO-ILLUMINATION TECHNIQUE SLIT LAMP IMAGES OF AN EYE IMPLANTED WITH AN INTRAOCULAR LENS (IOL, UNABLE TO IDENTIFY MODEL), SHOWED APPARENT LIGHT SCATTERING ARTIFACTS THAT WERE OBSERVED AND APPEARED TO BE IN THE IOL. THE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED AS NO PRODUCT WAS RETURNED FOR ANALYSIS. NO DETERMINATION COULD BE MADE FROM THE PICTURES PROVIDED AS IT IS DIFFICULT TO CONFIRM PRODUCT DAMAGE WITHOUT EVALUATION OF THE PHYSICAL PRODUCT. BASED ON THE RESULTS FROM THE PRODUCT AND BATCH HISTORY RECORD, THE PRODUCT MET RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. (B)(4).

    Description of Event or Problem · 1

    FURTHER INFORMATION WAS PROVIDED BY THE SURGEON WHO REPORTED THAT, IN HIS OPINION, THE DEVICE DID NOT CAUSE/CONTRIBUTE TO THE EVENT. POSTOPERATIVE HISTORY: (B)(6) 2015 SHORT FLICKERING. (B)(6) 2015 ACUTE VISUAL LOSS AFTER UNCONSCIOUSNESS AT PAIN OF THE LUMBAR SPINE. TREATMENT WITH NON-STEROID ANTIINFLAMMATORY CAPSULES. (B)(6) 2015 MISSING IMPROVEMENT AFTER ADMINISTRATION OF NON-STEROID ANTIINFLAMMATORY MEDICATION. (B)(6) 2015 VISUAL ACUITY IMPROVED AFTER ADMINISTRATION OF CORTICOSTEROID TABLETS BUT NOT TOLERATED WELL BY PATIENT. TREATMENT DURATION WAS 1 MONTH DUE TO UNCLEAR OBJECTIVE VISUAL REDUCTION AND "MISSING MORPHOLOGICAL SUBSTRATE". (B)(6) 2015 VISUAL ACUITY REPORTED TO BE DECREASED . (B)(6) 2015 TREATMENT WITH CORTICOSTEROID TABLETS DISCONTINUED. NO SIGNS OF MACULAR EDEMA IN (B)(6). (B)(6) 2015 AND (B)(6) 2015 DOCTOR DOES NOT ALLOW THE PATIENT TO WORK DUE TO A VISUAL ACUITY OF 0.6 (<20/32). (B)(6) 2015 IMPAIRED VISION, PATIENT WANTS TO CONSULT A SECOND HOSPITAL.

    Description of Event or Problem · 1

    (B)(6) 2015 CORTICOSTEROID TREATMENT DURATION WAS 1 MONTH DUE TO UNCLEAR OBJECTIVE VISUAL REDUCTION AND MISSING MORPHOLOGICAL CORRELATE.

    Description of Event or Problem · 1

    AN OPHTHALMOLOGIST REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE PATIENT EXPERIENCED A DECREASE IN VISUAL ACUITY. AFTER-CATARACT WAS TREATED WITH A CAPSULOTOMY PROCEDURE PERFORMED ON (B)(6) 2015. HOWEVER, THE VISUAL ACUITY DID NOT IMPROVE. THE REPORTER DETECTED A WAVY STRUCTURE IN THE IOL AND FLAT CLOUDINGS OF THE IOL ANTERIOR AND POSTERIOR SURFACE WERE CLEARLY VISIBLE. PATIENT REPORTED THAT SHE WAS INCAPACITATED TEMPORARILY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480630 ACRYSOF IQ NATURAL SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60WF 21119798

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other| R