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

Catalog Number 8065990713

Device Problem Incorrect Measurement (1383)

Patient Problem Visual Disturbances (2140)

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 device history records (dhr) for the device was reviewed.The associated device was released based on company acceptance criteria.The manufacturer internal reference number is: (b)(4).

Event Description

A facility representative reported two patients with two diopters of overcorrection following refractive treatment.Additional information has been requested.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

There are two related reports for this event.This report addresses the patient initials, dp, and another manufacturer report will be filed for the other patient.

Manufacturer Narrative

During technical onsite visit, the field service engineer (fse) performed all user tests and found the system meets within specifications.The logfile review shows no abnormalities or deviations can be detected in the logfiles, which can contribute the reported issue.The system was working within specification as intended.The reviewed treatment documents show a difference in pre op astigmatism and topographic astigmatism.The pre op topographies show a coma and irregular back surface of cornea.The surgeries are performed as photo refractive keratectomy (prk) and the provided post op topographies and the clinical refraction is only one and a half months after the surgery.For prk surgeries, the stabilization of the cornea might take up to 6 months.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: 8471218
• MDR Text Key: 140545994
• Report Number: 3003288808-2019-00369
• 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: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• 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: 07/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR