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

Catalog Number 8065990713

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 12/06/2018

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 following topography guided treatment the patient's sphere and astigmatism refraction is not as expected.The patient underwent corneal crosslinking just after the topography guided treatment for keratoconus.The procedure is considered off label treatment.Additional information has been requested.

Manufacturer Narrative

The device history records (dhr) for the device was reviewed.The associated device was released based on company acceptance criteria.Logfile review for the day of treatment shows all laser system functions were within specifications for the respective treatment.The corresponding treatment was performed without interruption.No abnormalities or deviations can be detected in the logfiles.Looking at the treatment report and the postoperative topography with its resulting astigmatism, the laser did what has been entered by the user.The central steepening is a result of the high amount of coma that has been ablated in the periphery.Knowing that this cornea had a keratoconus before the treatment, we can usually not predict any outcomes in refraction and behavior of the tissue itself.Afterwards a crosslinking has been performed to stabilize the cornea, which also might have had an influence on the biomechanics and therefore the unexpected outcome of the sphere.The treatment report shows that only the higher order aberrations have been treated, which fits to the refractive outcome of the astigmatism, that remained nearly the same.No technical root cause was identified as the product was found to be within specifications.The most possible root cause is user handling.Patients with diagnosis of keratoconus or any clinical pictures suggestive to keratoconus are contraindicated.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: 8179246
• MDR Text Key: 130878686
• Report Number: 3003288808-2018-01968
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065990713
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR