BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCUCOAT VISCOELASTIC

    MDR report key: 18897404 · Received March 13, 2024

    Report

    Report Number
    0001313525-2024-70065
    Event Type
    Injury
    Date Received
    March 13, 2024
    Date of Event
    October 19, 2023
    Report Date
    November 3, 2023
    Manufacturer
    BAUSCH + LOMB
    Product Code
    LZP
    UDI-DI
    00757770484799
    PMA / PMN Number
    P860047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE INVOLVED IN THIS EVENT WAS NOT RETURNED FOR EVALUATION. TWO UNUSED UNITS FROM THE SAME LOT WERE RETURNED AND EVALUATED. EVALUATION OF THE RETURNED PRODUCT CONFIRMED THAT ALL PACKAGING SEALS WERE INTACT FOR EACH COMPONENT (CANNULA NEEDLE AND RETENTION CLIP) AND SYRINGE. NO SEALS WERE BROKEN AND THERE WERE NO VISIBLE INTEGRITY OR APPEARANCE ISSUES WITH ANY OF THE COMPONENTS OR SYRINGES. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) DID NOT IDENTIFY ANY ANOMALIES OR NONCONFORMITIES THAT COULD BE RELATED TO THIS EVENT. THE LOT HISTORY, RISK ANALYSIS AND DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE ONE-DAY POST-OPERATIVE VISIT AFTER IMPLANTABLE COLLAMER LENS IMPLANTATION INTO BOTH EYES, THE SURGEON NOTED THE PATIENT PRESENTED WITH SEVERE CORNEAL EDEMA, INCREASED INTRAOCULAR PRESSURE AND SYMPTOMS OF POSSIBLE TASS. THE PATIENT WAS PRESCRIBED MEDICATION TO LOWER IOP AND REFERRED TO A RETINA SPECIALIST FOR FURTHER EVALUATION OF POSSIBLE CONDITIONS. THE ORIGINAL PROCEDURE WAS NOT COMPLICATED IN ANY WAY. PROCEDURE WAS APPROXIMATELY 15-30 MINUTES. CLEAR CORNEAL INCISION UTILIZED. INCISION WAS NOT SUTURED AT THE TIME OF ORIGINAL SURGERY. CLEANING AND STERILIZATION METHODS USED PRIOR TO SURGERY: THE INSTRUMENTS WERE DECONTAMINATED AND WASHED USING MULTI-ENZYMATIC CLEANER AND DISTILLED WATER, STERILIZED USING A STEAM AUTOCLAVE. THERE WAS NO EVIDENCE OR SUSPICION OF A WOUND LEAK POSTOPERATIVELY. ANTIBIOTIC/ANTISEPTIC/STEROID MEDICATIONS USED PREOPERATIVELY: PROLENSA 1QTT BID OU 3 DAYS BEFORE SURGERY, BESIVANCE 1QTT BID OU 3 DAYS BEFORE SURGERY, LOTEMAX 1QTT 4X OU 3 DAYS BEFORE SURGERY. ANTIBIOTIC, STEROID, NSAID PRESCRIBED POSTOPERATIVELY: MOXIFLOXACIN 0.5% 1 GTT OU TID, KETOROLAC 0.5% 1 GTT OU TID, DUREZOL 0.05% 1 GTT OU QH. PATIENT UNCOOPERATIVE WITH TOPICAL REGIMEN DUE TO PAIN. ON POD1, PATIENT HAD SUB-TENON KENALOG INJECTION PERFORMED OU. ON POD2, PATIENT HAD PPV +INTRAVENOUS INJECTION OF ANTIBIOTICS AND ANTERIOR VIT BIOPSY OU. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF EVENT IS POSTOPERATIVE INFECTION. RESULTS OF CULTURE & SENSITIVITY ARE PSEUDOMONAS AERUGINOSA SENSITIVITY. PATIENT OUTCOME IS POOR DUE TO NATURE OF SEVERE INFECTION, CAUSED BY P.AERUGINOSA ENDOPHTHALMITIS. DURING THE PATIENT'S SURGERY TWO UNITS WERE USED INDIVIDUALLY, ONE UNIT WAS USED FOR RIGHT EYE AND ONE UNIT WAS USED ON LEFT EYE. THIS REPORT IS FOR THE LEFT EYE (OS). RIGHT EYE (OD) REFERENCE:0001313525-2023-70130

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017550 OCUCOAT VISCOELASTIC AID, SURGICAL, VISCOELASTIC LZP BAUSCH + LOMB CC065S 029923 00757770484799

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female Required Intervention ICL,LIOLI-24 INJ,BETADINE-IODINE,MOXIFLOXACIN PF