MAUDE Adverse Event Report: WAVELIGHT GMBH WAVELIGHT EX500 EXCIMER LASER; OPHTHALMIC EXCIMER LASER SYSTEM

Catalog Number 8065990794

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Blurred Vision (2137); Visual Impairment (2138)

Event Date 03/12/2020

Event Type  Injury  

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).

Event Description

A physician reported a patient that underwent photo refractive keratectomy (prk) performed by a resident, and on the post-operative visit it appears there was no treatment delivered to the left eye.The laser printout shows treatment was delivered.The observing doctor stated the view of the eye is a little blurry and he cannot see the epithelium removal demarcation line.On evaluation by the optometrist, it is noted there is a healing epithelium suture line, so it appears there was epithelium removal.The keratometry measurements, topography and refractions show no evidence of any treatment.Additional information received reported no technicians in the room observed that the epithelium was not properly removed.When the following surgeon's tray was set up he noted that the prk brush head was not spinning, as if the rotating gear was stripped.The surgeon called for a new prk brush assembly and proceeded with a normal prk case.The resident apparently made a slight indentation on the cornea by applying pressure with the prk brush, but mistook the fainter outline for the edge of the epithelium.

Manufacturer Narrative

Additional information provided in h.3., h.6., and h.10.The device history records (dhr) for the device was reviewed.The associated device was released based on company acceptance criteria.A review of the technical service onsite history showed no abnormalities that could have contributed to this event: laser was successfully verified prior to and after treatment date.Review of the logfile for the day of treatment shows no relevant error or warning messages.During the start-up in the morning the system passed all initialization steps without any relevant deviation.The user performed the gas change, skipped the scanner test and performed the necessary energy, eyetracker and fluence test without any issue.The logfile shows multiple successfully performed treatments.The treatment could be identified in logfile.The user performed an energy check before this patient, but the corresponding treatment was approximately fourteen hours later.However, it is recommended, that an energy test is performed before each patient cas (clinical application specialist) review concluded as follows: it was reported that after ablation the patient had similar refraction and keratometry readings like prior to the surgery on the left eye.The right eye was treated and the postoperative refraction was as planned.The removal of the prk (photo refractive keratectomy) was performed with a brush.The treatment report and also the corresponding documents show that the epithelium has not been removed by the surgeon prior to the laser ablation.In the email communication this has been confirmed by one of the doctors of the clinic.The treatment was applied to the eye without removing the epithelium.Therefore the refractive effect is missing because the epithelium is growing back over time within the healing process.The technical evaluation showed that there was no technical issue on that day and there were no further cases reported.A technical root cause could be excluded as the system was working within specification.The root cause is user error.The manufacturer internal reference number is:(b)(4).

• Brand Name: WAVELIGHT EX500 EXCIMER LASER
• Type of Device: OPHTHALMIC EXCIMER LASER SYSTEM
• Manufacturer (Section D): WAVELIGHT GMBH; am wolfsmantel 5; erlangen 91058 ; GM 91058
• MDR Report Key: 10082595
• MDR Text Key: 191819121
• Report Number: 3003288808-2020-00329
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• PMA/PMN Number: P020050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065990794
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 26 YR