BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS WITH HYDRACLEAR PLUS

    MDR report key: 1823389 · Received August 25, 2010

    Report

    Report Number
    1033553-2010-00053
    Event Type
    Injury
    Date Received
    August 25, 2010
    Date of Event
    July 6, 2010
    Report Date
    August 25, 2010
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    P040045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    LABELED FOR SINGLE USE AND REUSE. A DEVICE HISTORY RECORD REVIEW REVEALED THE FOLLOWING: THE BATCH RECORD DID NOT SHOW ANY ABNORMALITIES IN MONOMER AND SOLUTION TESTING. ALL PARAMETERS TESTED WERE WITHIN SPECIFICATION. ALL STERILIZATION REQUIREMENTS WERE SUCCESSFULLY COMPLETED. TWO SEALED BLISTERS WERE RETURNED. THE PARAMETERS OF THE LENSES WERE MEASURED AND A VISUAL INSPECTION WAS PERFORMED. THE LENSES MET COMPANY STANDARDS FOR BASE CURVE, CENTER THICKNESS, AND DIAMETER. NO VISUAL ATTRIBUTES WERE OBSERVED. THE SOLUTION WAS ALSO TESTED. THE PH WAS WITHIN SPECIFICATION. THERE WAS NOT ENOUGH SOLUTION TO TEST FOR CONDUCTIVITY. MDR REPORTABLE EVENT TRENDS ARE REVIEWED QUARTERLY IN EXECUTIVE MGMT REVIEW MEETINGS.

    Description of Event or Problem · 1

    THIS REPORT IS FOR PT'S LEFT EYE (OS). WE RECEIVED INFO FROM A PT INDICATING THAT ABOUT 8 WEEKS PRIOR, THE PT EXPERIENCED IRRITATION IN BOTH EYES (OU) WHILE WEARING ACUVUE OASYS CONTACT LENSES (CL). THE PT SAID THE LENSES WERE WORN FOR 3 TO 4 DAYS SUCCESSFULLY PRIOR TO THE ONSET OF SYMPTOMS (SX). DISCUSSED THAT THERE WERE DIFFERENT LOTS THAT WERE MFG ABOUT 5 1/2 MONTHS APART. THE PT WAS INITIALLY USING OPTI-FREE REPLENISH MPS AT THE ONSET OF THE SX. THE PT SWITCHED TO RENU MPS AND HAD SIMILAR SX FOLLOWING 3 TO 4 DAYS OF WEAR. THE PT PROVIDED THE TREATING EYE CARE PROFESSIONAL'S (ECP) CONTACT INFO AND RETURNED THE BALANCE OF THE LENSES IN QUESTION FOR EVAL. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE ECP. SPOKE WITH THE ECP ON (B)(6)2010, THE ECP BRIEFLY DISCUSSED THE CASE AND NOTED THAT THE PT HAD A MILD IRITIS. THE ECP NOTED THAT HE DID NOT BELIEVE THAT THE IRITIS WAS CAUSED BY CL WEAR, BUT HE COULD NOT RULE OUT THAT THE CL MAY HAVE CONTRIBUTED TO THE EVENT. THE ECP PROVIDED THE PT'S RECORD. THE FOLLOWING INFO IS FROM THE PT'S TREATMENT RECORD. THE PT WAS INITIALLY SEEN ON (B)(6)2010 FOR RED EYES. THE PT REPORTED OD>OS, THE ONSET WAS (B)(6)2010, OS "SWELLED PAST LIDS", THERE WAS NO DISCHARGE. THE SLIT LAMP EXAM (SLE) FOUND CONJ INJECTION OS>OD; CORNEA: TRACE INFILTRATES OS; A/C D&Q. ASSESSMENT: CONJUNCTIVITIS OS>OD SLE: ZYLET QID OU. RETURN TO OFFICE (RTO) 7 DAYS. ON (B)(6)2010: PT RETURNED FOR F/U EXAM. PT SAID REDNESS DECREASED AFTER 3 DAYS OF ZYLET. SLE: CONJ: TRACE CONJ INJECTION OU; CORNEA; CLEAR; A/C D&Q. ASSESSMENT: RESOLVED CONJUNCTIVITIS; PLAN: ZYLET BID X 2 DAYS THEN D/C; RETURN TO CL WEAR; USE ARTIFICIAL TEARS (AT). ON (B)(6)2010: PT RETURNED TO ECP. PT SAID THAT ON (B)(6)2010, EYES WERE MILDLY RED AS THEY WERE AT THE INITIAL VISIT AND PT CALLED ECP FOR ZYLET REFILL. ON (B)(6)2010, PT'S EYES WERE BLOOD SHOT WITH NO DISCHARGE. PT WENT TO COMMUNITY CLINIC AND WAS TOLD DX: IRITIS VS REACTION TO ZYLET OR CONJUNCTIVITIS. PT WAS NOT SATISFIED WITH THAT INFO AND WENT TO AN ER. PT WAS TOLD POSSIBLY CONJUNCTIVITIS OR SIGN OF KIDNEY DAMAGE. ER DID NOT DO BLOOD WORK-UP. NO MEDS GIVEN, NO IRITIS. TODAY MUCH LESS RED. ON (B)(6)2010 (CONTINUED) VA 20/25 OU. SLE: CONJ INJ GRADE 2; CORNEA CLEAR OU, A/C +CELLS OU (2): IRIS CLEAR. ASSESSMENT: CONJUNCTIVITIS VS IRITIS; REMNANT VS ONSET (OF IRITIS). PLAN: D/C ZYLET, START PRED FORTE Q1H X 1 DAY THEN Q2H TOMORROW RTO 2 DAYS." ON (B)(6)2010: "MED F/U. EYE/REDNESS MUCH IMPROVED. HAD BLOOD WORK-UP. EVERYTHING SO FAR IS NORMAL. VA 20/25 OU. SLE: CONJ INJ +1 OU, CORNEA CLEAR; A/C +CELLS OD 3, OS 3. IRIS: CLEAR. ASSESSMENT: TRACE IRITIS? PLAN: CONT PRED FORTE Q2H X 2 DAYS THEN QID UNTIL RTO." ON (B)(6)2010: "VA 20/25 OU. MED F/U. FEELS MUCH BETTER, REDNESS REDUCED. SLE: CONJ: TRACE INJECTION OU; A/C D&Q; LENS: CLEAR. ASSESSMENT: RESOLVED CONJUNCTIVITIS, PLAN: PRED FORTE BID X 3 DAYS THEN D/C. RTO 2 WEEKS." ON (B)(6)2010: "FEELS MUCH BETTER, EYES CLEAR OU. VA CC OD 20/30, OS 20/25. FROM BLOOD WORK LAST WEEK, SED RATE WAS 26, MD WAS NOT CONCERNED. ASSESSMENT: DRY EYE DISEASE; PLAN: ARTIFICIAL TEARS PRN. VA CC OD 20/30, OS 20/25." THE PT WAS RX 1-DAY TRUEYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUVUE OASYS WITH HYDRACLEAR PLUS SOFT CONTACT LENS LPL VISTAKON NA B008CRB

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other RENU MPS| OPTI-FREE REPLENISH MPS