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

Catalog Number 8065990713

Device Problems Unstable (1667); Firing Problem (4011)

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

Event Date 11/28/2018

Event Type  malfunction  

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 device history record (dhr) for the device has been reviewed.The associated device was released based on company's acceptance criteria.(b)(4).

Event Description

A company representative reported that the laser did not fire on one spot of the cornea.Doctor requested an energy report from a company representative in order to check the stability of the energy for the treatment patient.Additional information has been requested.

Manufacturer Narrative

(b)(4).

Event Description

Upon follow up, photo refractive keratectomy procedure was completed.No patient harm was reported.

Manufacturer Narrative

Logfile review for the day of treatment showed no error messages or corresponding warnings.During the start-up in the morning, the system passed all initialization steps without any relevant deviation.The user skipped the gas change, skipped the scanner test and performed the necessary energy, eye tracker and fluence test without any issue.The logfile showed successfully performed treatments.According to the missing information about the treatment details, the related treatment cannot be identified.The review of the complete day showed no abnormalities or deviations.The user performed energy checks before each patient.The energy was stabile the whole day.All treatments were performed without interruption.No abnormalities or deviations can be detected in thelogfiles which can contribute the reported issue.No technical root cause was identified as the product was found to be within specifications.The root cause could not be determined conclusively.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: 8164280
• MDR Text Key: 130471419
• Report Number: 3003288808-2018-01947
• 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,Followup
• Report Date: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065990713
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1