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 Problem Therapeutic Response, Decreased (2271)

Event Date 03/04/2020

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 risk manager reported a patient with an unexpected outcome of the right eye following photo refractive keratectomy (prk).Upon chart review it was noted that the patient was treated with a +2.00 cylinder instead of a -2.00 cylinder.The patient is set to return in two months for an additional postoperative exam and will have prk again when the vision is stable.

Manufacturer Narrative

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 the day of treatment.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 many successfully performed treatments.The treatment could be identified in logfile.The user performed an energy check in the morning, however the treatment was not performed until the afternoon.It is recommended, that an energy test is performed before each patient.The measured energy was stable.The logfiles show the treatment was performed successfully without any issue.No technical root cause could be identified during logfile review.User error, laser was programmed for a +2.00 cylinder instead of a -2.00 cylinder.According to logfile review the device worked as intended.The manufacturer internal reference number is: 2020-17993.

• 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: 9944086
• MDR Text Key: 187699373
• Report Number: 3003288808-2020-00292
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 03/18/2020,06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2020
• 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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/04/2020
• Device Age: 4 YR
• Event Location: Other
• Date Report to Manufacturer: 03/18/2020
• Date Manufacturer Received: 05/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 44 YR