[475680]
Pt is a laser pt of ours who first had ipl done in 2006. Her second treatment was done the next month, third treatment the next. She came in at 9:30 am this morning for her fourth treatment. She had not had any problems previously with her treatment, except a mild "heat rash" on her face after her second visit, which could be a normal variance of the ipl procedure. We are in the process of training our esthetician. She is a licensed esthetician who has gone through cutera laser training. This was the second ipl pt that i watched her do. She had seen me do four previous ipl pts by myself and i was in the room with her. This time also, i was in the room with her to monitor her correct ipl use. The pt had removed all of her makeup, lotions, moisturizers, etc. , prior to coming to the office. We applied the ipl-aid product following instructions on the directions for use info. This was the fourth time that she would be using this product. The three previous times she had not had any problems. We had been using this product for approx seven months without any adverse problems in the past. We treated the pt's right side of the face without incident. After nurse had correctly applied the ipl-aid, to the pt herself, esthetician proceeded to start doing the left side of her face while i observed her. Every time she placed the ipl machine on pt's face, i was there to check placement of the machine, prior to being fired. Upon firing the machine which was set at 20 joules, which is the same setting that had been used at the previous two appointments, the area by the pt's left eye had a very, very large bright light appear and then a very strong chemical smell appeared, & then the pt started complaining of terrible pain to her left eye. The procedure was immediately aborted. The pt appeared uncomfortable. The ipl-aid patch was removed from her left eye by nurse. We saved the eye patch & labeled it as to which eye patch covered which eye. This is indicated inside of her chart. As soon as nurse removed the eye patch, the pt complained of terrible burning. She appeared to have very watery eyes, but no obvious sign of injury, redness, bleeding, or irritation to the eye itself. A wet cotton ball with water was used to wipe the area gently to inspect the eye. Again, no area of trauma was noted, except for some very mild singeing of her eyelashes. The pt continued to complain of burning over the course of the next five minutes, and then it began to resolve. Post pictures were taken, which are also located in the pt's chart approx seven minutes after the incident. These pictures were also shown to the pt, which shows that there is no obvious injury to the eye, except some mild lash singeing. Approx ten minutes after the procedure, after explaining that we did not know the cause of the incident, the pt requested that we complete treatment, as it did not appear to be a problem with the actual ipl handpiece itself. The pt was informed that i was not aware of the cause of the incident and coulden't guarantee that the incident wouldn't recur, but she desired to proceed with treatment. The remainder of her face was completed by esthetician with me observing appropriate placement & treatment. Pt tolerated this procedure well and there were no further adverse events. By the time the pt left the clinic (around 10:30 a. M. ) the day of her procedure, she stated that her eye was feeling much better and was just slightly stingy feeling. The pt left the clinic in stable condition. We immediately stopped using the ipl-aid and i finished seeing pts. Pt was given instructions that if her eye started to bother her, or if she started to have any problems at all that she was to notify the clinic. After i was done seeing pts, i attempted to replicate the problem. When i put the cutera ipl handpiece on top of the ipl-aid disposable eye shield, i was able to replicate the same problem. The ipl-aid bubbled up, produced a very strong chemical smell, and was very warm to touch after being treated with the machine. The green hue that was noted on pt's ipl-aid disposable eye shield after use was also replicated on this other eye shield. I was concerned that there might be a problem with the lot, so i opened a brand new box, which we just received from pss today, lot # ktk, and i also had the same adverse event with the bubbling, chemical smell & heat produced. We called the pt at 4:30 p. M. To see how she was doing and she states that she's not having any eye pain, blurry vision, or problems except for some mild redness to the left outer aspect of her lower lid, which she states is similar to the other areas on her face that had been ipl'd. She felt that this was the expected ipl reaction and didn't appear different from the surrounding area. I explained to her that if she should have any vision problems, sudden eye pain, or any new developments, she was to go to the emergency room for eval. The pt is aware that i have concerns about the ipl-aid disposable eye shields. I attempted to contact the co. The co's name is glendale, but i rec'd a voice message, so i left a message for them to return my call on monday. It is possible that when esthetician placed the ipl handpiece by the pt's eye, that from my particular viewing angle, that i was unable to see a potential overlap onto the inner shield of the ipl disposable eye shield. Regardless, there's no instructions in the information provided with the product that says caution needs to be taken in any particular area, but in an attempt to replicate, it appears that the darkish inner shield is what sort of becomes affected by the ipl. If she had some minor overlap that i was not able to see, it is possible that is what triggered the reaction, since the clinical response that we saw, was identifical to when i tested it on the thinner part of the eye shield when it was not on the pt. In review of the general info of the ipl disposable eye shield, it states that it is (more....
Patient Sequence No: 1, Text Type: D, B5