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

Catalog Number 8065990794

Device Problem Incorrect Measurement (1383)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/05/2019

Event Type  Injury  

Manufacturer Narrative

The device history records (dhr) for the device were reviewed.The associated device was released based on acceptance criteria.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.(b)(4).

Event Description

A customer reported wrong measurements and an unexpected outcome in the right eye post lasik.The lasik treatment was completed in the traditional way using a microkeratome blade and 120 micron flap.Additional information requested.

Manufacturer Narrative

Review of the logfile for the day of treatment shows 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 check, eyetracker and fluence test without any issue.The logfile shows 53 successfully performed treatments.The user performed an energy checks before each eye of this patient.The energy was stable during the whole day.The corresponding treatments were performed without interruption.No abnormalities or deviations can be detected in the logfiles, which can contribute the reported issue.Cas (clinical application specialist) review states: by looking at the treatment report, we see that the right eye was covered partially with a sponge during the ablation.We recommend to protect the hinge during the laser ablation to avoid the ablation on the flap.In this case the treatment area was also covered partially, which might have prevented an accurate ablation and therefore the refractive outcome might have changed.Also we see, that there has been a peripheral bleeding due to the flapcut with the microkeratome.Sometimes these bleedings could also run slightly towards the ablation area and could have an effect on the ablation.Additionally the surgeon used two sponges during the ablation.One for protecting the hinge and for stopping the bleeding from running towards the interface.With this second sponge there might also be some shadowed areas during the ablation, but this can not be seen on the treatment report since it only shows parts of the treatment.During the on site visit the field service engineer(fse) found the bed position was off in y-direction, this however could not be determined conclusively as root cause for the reported event.Fse repositioned the patient bed, repositioned the laser,as a preventive measure, and performed preventive maintenance and a full system check.The root cause could be determined as user handling.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: 8812127
• MDR Text Key: 151743098
• Report Number: 3003288808-2019-00753
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065990794
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: WAVELIGHT OCULYZER; WAVELIGHT OCULYZER II, 8065990793, WAVELIGHT; WAVELIGHT OCULYZER
• Patient Outcome(s): Other
• Patient Age: 24 YR