Description of Event or Problem · 0
IRIDEX BECAME AWARE OF A PATIENT THAT EXPERIENCED A CONJUNCTIVAL BURN DURING TREATMENT WITH THE MICROPULSE P3 PROBE DELIVERY DEVICE. THERE IS NO ADDITIONAL INFORMATION REGARDING THE REPORTED ADVERSE EVENT. THERE WAS NO RECORD OF THE COMPLAINANT OR REPORTER INFORMATION. IT IS UNKNOWN IF THE EVENT WAS CAUSED BY A USER OR DEVICE RELATED. DEVICE WAS NOT RETURNED TO IRIDEX FOR FURTHER INVESTIGATION. NO TREATMENT PARAMETERS OR PATIENT RELATED INFORMATION WAS SHARED TO REACH A CONCLUSIVE FINDING. OPHTHALMIC LASER SYSTEMS ARE INTENDED TO DELIVER THERMAL (LASER) ENERGY TO DELIVER AN INSULT (BURN) TO THE CILIARY BODY. CONJUNCTIVAL BURNS ARE A KNOWN AND PREDICTED COMPLICATION ASSOCIATED WITH THE USE OF ANY OPHTHALMIC LASER SYSTEM (CONSOLE AND DELIVERY DEVICE) WHEN USED TO DELIVER TRANSSCLERAL TREATMENT. IT IS LISTED AS A POSSIBLE COMNPLICATION IN THE IFU FOR MP3 DELIVERY DEVICE. CONJUNCTIVAL BURNS ARE A SPECIFIC TYPE OF OCULAR BURN THAT CAN OCCUR ALONG WITH CORNEAL BURNS, OFTEN DUE TO CHEMICAL OR THERMAL INJURY AND ARE TYPICALLY SUPERFICIAL, POSING NO LONG-TERM THREAT TO THE PATIENT. TYPICALLY, THESE BURNS RESOLVE WITHIN 24-48 HOURS POST OP WITHOUT ADDITIONAL INTERVENTION. IRIDEX CORPORATION DOES REPORT EVERY ADVERSE EVENT VIA THE FDA'S MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE (MAUDE) DATABASE. ANOTHER FACTOR TO BE TAKEN INTO ACCOUNT IS THAT OCCASIONALLY, THE TIP OF THE PROBE WILL BECOME CONTAMINATED WITH BLOOD OR TISSUE, AND THE CONTAMINANTS ON THE TIP CAN BECOME HATED WHEN EXPOSED TO LASER ENERGY. CONTAMINATION OF THE FIBER OPTIC TIP BY BLOOD OR TISSUE CHAR MAY RESULT IN OCULAR SURFACE BURNS AND A SMOKING TIP OF THE PROBE.