ILUX SYSTEM 1.5 DEVICE

Additional Manufacturer Narrative

THE PATIENT WAS SCHEDULED FOR A MEIBOMIAN BLOCKAGE TREATMENT. THE CUSTOMER ORIGINALLY REPORTED AN OUTCOME OF ¿THERMAL KERATITIS.¿ THE SURGEON DIAGNOSED THE FOLLOWING OF THE PATIENT: THERMAL KERATITIS, ANTERIOR IRITIS, CORNEAL EDEMA AND A CORNEAL ABRASION. ALL OF THE SYMPTOMS HAVE RESOLVED AT THIS TIME, AND THE PATIENT IS WITHOUT HARM. THE ACCOUNT MANAGEMENT REPRESENTATIVE (AM) HAS THE DEVICE READY TO BE RETURNED. THE AM STATES THAT ONLY HALF OF THE TIP WAS USED AND THAT NO SYSTEM MESSAGE WAS DISPLAYED AT THE TIME OF THE EVENT. THIS TREATMENT WAS BEING DONE WITH HER SUPERVISION, AS THIS WAS A TRAINING. THE COMPANY REPRESENTATIVE SPOKE TO THE AM ON 12-NOV-2019. THE AM CONFIRMED THAT SHE WAS TRAINING THE SURGEON WHEN THE SUSPECTED EVENT OCCURRED. THE SURGEON CONFIRMED ¿(AFTER THE PROCEDURE) THERE WAS ¿EVIDENCE OF AN ANTERIOR SEGMENT INFLAMMATION, ACCOMPANIED BY A CORNEAL ABRASION.¿ THIS FINDING IS WHAT LEAD THE SURGEON TO HIS ORIGINAL DIAGNOSIS OF ¿THERMAL KERATITIS.¿ ADDITIONAL INFORMATION OBTAINED FROM THE SURGEON, INDICATES THAT ¿THE PATIENT'S CORNEA WAS NEVER IN CONTACT WITH THE DEVICE DURING THE PROCEDURE.¿ THE PATIENT WAS MANAGED WITH TOPICAL MEDICATIONS (STEROID). ALL SYMPTOMS WERE RESOLVED WITHIN ONE WEEK, WITH NO RESIDUAL ISSUES. HOWEVER, THE SURGEON DID MENTION ¿THAT THIS SPECIFIC PATIENT WAS PRONE TO CORNEAL BREAKDOWN AND EPITHELIAL EROSIONS.¿ THE AM AND THE COMPANY REPRESENTATIVE HAVE CONCLUDED ¿GIVEN THE PATIENTS¿ CORNEAL HISTORY, THE PATIENT WAS NOT AN IDEAL CANDIDATE FOR THE PROCEDURE AND SHOULD NOT HAVE BEEN CONSIDERED.¿ THE AM HAS CONFIRMED THAT THE ORIGINAL DEVICE BEING USED HAS BEEN REPLACED WITH A SECOND UNIT. THERE HAVE BEEN NO FURTHER ISSUES REPORTED TO DATE. THE SURGEON HAS NOT BEEN RESPONSIVE TO ANY FOLLOW UP COMMUNICATIONS AND NONE IS EXPECTED AT THIS TIME. MEIBOMIAN GLANDS ARE LOCATED IN THE TARSAL PLATE OF THE UPPER AND LOWER EYELIDS, WITH SECRETORY ORIFICES LOCATED ALONG THE INTERIOR RIM (OR MARGIN) OF THE EYELIDS. THESE GLANDS SECRETE MEIBUM, WHICH IS A LIPID-RICH ESSENTIAL COMPONENT OF A HEALTHY TEAR FILM. WHEN SUFFICIENT MEIBUM IS NOT PRESENT (IN THE TEAR FILM), THE AQUEOUS LAYER OF THE TEAR FILM IS DISRUPTED, AND READILY EVAPORATES CAUSING IRRITATION, REDNESS, AND INFLAMMATION OF THE LID MARGIN AND SURROUNDING TISSUES. MEIBOMIAN GLAND DYSFUNCTION (MGD) IS ASSOCIATED WITH A FAILURE OF THESE GLANDS TO PRODUCE ADEQUATE QUANTITIES OF MEIBUM DUE TO ATROPHY, INFLAMMATION, OR OBSTRUCTION OF THE ORIFICES, AND IS THOUGHT TO BE THE MOST COMMON CAUSE OF EVAPORATIVE DRY EYE DISEASE (EDE). A COMMON CLINICAL TREATMENT TO RESTORE NORMAL GLAND FUNCTION IN PATIENTS WITH OBSTRUCTIVE MGD INVOLVES THE APPLICATION OF HEAT AND PRESSURE THERAPY TO THE EYELIDS TO UNBLOCK THE ORIFICES AND EXPRESS THE MEIBOMIAN GLAND OBSTRUCTIONS AND OTHER MATERIAL FROM THE GLANDS. WARMING THE EYELID TISSUE SOFTENS OR MELTS THE MEIBUM, WHICH IS KNOWN TO FACILITATE EXPRESSION, USING PRESSURE. THE DEVICE IS INTENDED FOR USE BY LICENSED EYE CARE PROFESSIONALS (ECPS) TO APPLY LOCALIZED HEAT AND PRESSURE THERAPY TO LOWER OR UPPER EYELIDS. THE SYSTEM CONSISTS OF A HANDHELD INSTRUMENT COUPLED TO A SINGLE-USE, STERILE SMART TIP PATIENT INTERFACE COMPONENT THAT IS POSITIONED BEHIND THE EYELID. THE DEVICE ALLOWS AN ECP TO VIEW THE EYELID MARGIN THROUGH A MAGNIFIER, THEN WARMS THE EYELID TISSUE TO A TARGET RANGE OF 38 TO 44°C TO MELT THE MEIBUM BLOCKING THE ORIFICES, AND THEN APPLY COMPRESSION TO THE EYELID TO EXPRESS THE MELTED MEIBUM THROUGH THE ORIFICES. AT ALL TIMES, THE AMOUNT OF HEAT AND PRESSURE APPLIED IS UNDER DIRECT CONTROL OF THE ECP WHO MONITORS THE RESPONSE OF THE GLANDS AND THE COMFORT OF THE PATIENT. THE TIP PATIENT INTERFACE IS A STERILE, SINGLE-PATIENT USE DEVICE. IT HAS AN INNER PAD AND AN OUTER PAD. THE INNER PAD SLIPS BEHIND THE EYELID BEING TREATED, WHILE THE OUTER PAD STABILIZES THE EYELID DURING THE HEATING PHASE OF THE TREATMENT, AND IS PRESSED AGAINST THE EYELID DURING EXPRESSION PHASE OF THE TREATMENT. BOTH PADS ARE COVERED WITH A SOFT, BIOCOMPATIBLE SILICONE MATERIAL. THE MANUAL STATES, ¿ALL MAKEUP ON THE EYELIDS BEING TREATED MUST BE REMOVED PRIOR TO TREATMENT. MAKEUP ON THE EYELID CAN ABSORB LIGHT AND BE HEATED, WHICH CAN RESULT IN DISCOMFORT.¿ POTENTIAL ADVERSE EFFECTS MAY OCCUR BECAUSE OF THE PROCEDURE. THESE EFFECTS INCLUDE (BUT ARE NOT LIMITED TO), THE ONSET OR INCREASE IN: EYELID/EYE PAIN REQUIRING DISCONTINUATION OF THE TREATMENT PROCEDURE, EYELID IRRITATION OR INFLAMMATION, TEMPORARY REDDENING OF THE SKIN, OCULAR SURFACE IRRITATION OR INFLAMMATION (E.G., CORNEAL ABRASION, CONJUNCTIVE EDEMA OR CONJUNCTIVAL INJECTION (HYPEREMIA), AND/OR OCULAR SYMPTOMS (E.G., BURNING, STINGING, TEARING, ITCHING, DISCHARGE, REDNESS, FOREIGN BODY SENSATION, VISUAL DISTURBANCE, SENSITIVITY TO LIGHT). WITH THE INFORMATION MADE AVAILABLE ON THE REPORTED EVENT, A ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO PATIENT PHYSIOLOGY AND ANATOMIC ANOMALIES. THE DEVICE WAS RECEIVED AND A VISUAL ASSESSMENT OF THE RETURNED SAMPLE SHOWED NO VISUAL NONCONFORMITIES. A REVIEW OF THE DEVICE¿S EVENT LOGS DID NOT INDICATE ANY NONCONFORMITIES OR SYSTEM MESSAGES (SM) PRESENTED AT THE TIME OF THE REPORTED EVENT. THE SAMPLE WAS TESTED USING MULTIPLE DEVICE TIPS FOR MOCK PROCEDURES, WHERE IT FUNCTIONED AS INTENDED. THE SAMPLE WAS THEN TESTED AND FOUND TO MEET PRODUCT SPECIFICATIONS. THE DEVICE WAS MANUFACTURED ON APRIL 19, 2019. BASED ON QA ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE TIP WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER (L/N) WAS NOT PROVIDED AND COULD NOT BE DETERMINED BASED ON THE INFORMATION PROVIDED. THEREFORE, MANUFACTURING INFORMATION COULD NOT BE OBTAINED. THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO PATIENT CONDITION/NON-PRODUCT RELATED FACTORS. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Description of Event or Problem

A PHYSICIAN REPORTED THAT THE EVENING OF A PROCEDURE THE PATIENT PRESENTED WITH THERMAL KERATITIS, ANTERIOR IRITIS, CORNEAL EDEMA AND A CORNEAL ABRASION. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON STATING THE PATIENT'S CORNEA WAS NOT IN CONTACT WITH THE PRODUCT DURING THE PROCEDURE. THE PATIENT WAS MANAGED WITH TOPICAL STEROID DROPS AND ALL SIGNS/SYMPTOMS RESOLVED WITHIN ONE WEEK WITH NO RESIDUAL ISSUES. THE SURGEON MENTIONED THE PATIENT WAS PRONE TO CORNEAL BREAKDOWN/EPITHELIAL EROSIONS.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION IS PROVIDED IN B.2. AND B.5. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Description of Event or Problem

ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON STATING THE PATIENT'S CORNEA WAS NOT IN CONTACT WITH THE PRODUCT DURING THE PROCEDURE. THE PATIENT WAS MANAGED WITH TOPICAL STEROID DROPS AND ALL SIGNS SYMPTOMS RESOLVED WITHIN ONE WEEK WITH NO RESIDUAL ISSUES. THE SURGEON MENTIONED THE PATIENT WAS PRONE TO CORNEAL BREAKDOWN/EPITHELIAL EROSIONS.

Additional Manufacturer Narrative

INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Description of Event or Problem

A PHYSICIAN REPORTED THAT THE EVENING OF A PROCEDURE THE PATIENT PRESENTED WITH THERMAL KERATITIS, ANTERIOR IRITIS, CORNEAL EDEMA AND A CORNEAL ABRASION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.