LASIK EYE SPEAR

[280023] The adverse event and product problem at the facility occurred in 2002, in connection with the facility's performance of the lasik procedure on 22 pts. Specifically, 21 out of 22 pts receiving the lasik procedure that day developed dlk (diffuse lamellar keratitis) on the first post-operative day. In response to the development of dlk by pts, the facility's physicians were required to provide medical intervention to preclude permanent impairment. Specifically, facility's physicians immediately increased the frequency of the recommended usage of the steroid eye drops for each pt with dlk. In addition, the facility's physicians prescribed systemic steroids for each of the pts having dlk. The physicians also had several follow up visits with each of the affected pts in order to monitor the dlk. In most instances, the pt was seen every day or every other day. In 17 instances, the facility's physicians eventually had to re-lift the pts' flap and irrigate the eye in order to stop the dlk from progressing. As of the date of this report, the dlk has cleared in all pts. However, a few pts may need up to 3 months of healing to determine their final visual acuity and there is a possibility of some corneal scarring central that the facility continues to monitor in those pts. Most of the pts' visual acuity-corrected is 20/40 or better as of the date of this report. In an attempt to determine the cause of the dlk, facility investigated the variables involved with surgery in 2002 and determined that 2 variables may have contributed to the problems. Those variables are: (1) the sterilizer used to sterilize the medical instruments; and (2) use of a new type of sterile ophthalmic surgery sponge (spear). With respect to the first variable the facility contacted its laser company clinical manager and she informed the facility that endotoxins in the sterilizer could contribute to dlk. She told the facility that she had experienced problems with endotoxins in a sterilizer at another facility. As such the facility sent a culture of the sterilizer reservoir water for a test of gram negative rod bacteria that produces endotoxins. The preliminary sterilizer water culture showed no growth overnight, the final showed total organisms of 1076 cfu/ml, 0 cfu/ml for coliform and 0 cfu/ml for pseudomonas. The facility then sent a second sample for culture along with samples of the facility's medications for culture. The medication cultures all came back with no growth. Preliminary lab results of the second sterilizer reservoir water showed 2 colonies of gram negative rod bacteria present with the level of 0. 881 eu/ml. These bacteria produce endotoxins. From what the facility understands from the lab, there are no industry standards for safe levels of endotoxins for corneal tissue. However, the lab gave the facility the following guidelines for acceptable levels of endotoxins for medical devices; extracted in 40 ml of pyrogen free water, according to the fda guideline, is less that 0. 5eu/ml or less than 20 eu/device for blood contacting devices and less than 0. 06 eu/ml or less than 2. 4 eu/device for devices contacting cerebro spinal fluid. With respect to the second variable, it is important to point out that the day of the event was the first time (other than the co's "trial" of spears which occurred prior to the day of event without incident) that the facility's physicians used a new type of sterile ophthalmic surgical sponge (spears). The physician performing surgery on the day of the event commented that the spears did not seem to absorb the fluids in the eye during surgery as the old spears had. The physician also stated that the new spears did not seem to act the same as the old ones, that the new spears did not seem to act the same as they did during the "trial", and that they seemed "coated". Furthermore, the 1 patient who received surgery on the day of the event but who did not develop dlk had a procedure that involved the use of a spear, but the amount of time that the spear had contact with the interface in this patient was much less than with the other 21 patients. This procedure also involved a scrapping of the interface which was felt to reduce the presence of endotoxins at the site. As such, the spears were immediately suspected and the facility contacted b-d (the supplier of the spears) to inform them of the problem. The b-d rep told the facility that he was aware of 1 other facility that had problems with the spears (same product number, but different lot number). He indicated that he would notify the appropriate depts at b-d for follow up. At the same time, the facility also internally began to investigate whether the spears caused or contributed to the problem. The facility learned that another facility had a similar problem in the fall of 2001. The facility contacted that facility and they informed the facility that they had in fact had problems with the spears and that they had filed a complaint with the mfr concerning the problem. The facility then contacted the mfr and they confirmed the complaint and told the facility they had investigated the spears. They informed the facility that they had turned in their findings to the fda and that no recall of the spears was suggested from the fda. At this point, and based upon the foregoing, the facility has reason to believe that the b-d spears caused and/or contributed to the problems experienced on the event date.
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