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

Catalog Number 8065990794

Device Problems Improper or Incorrect Procedure or Method (2017); Improper Device Output (2953); Data Problem (3196)

Patient Problems Corneal Edema (1791); Dry Eye(s) (1814)

Event Date 03/31/2016

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: no sample is expected for evaluation.The device history records (dhr) for the device was reviewed.No abnormalities that could have contributed to this event were found.The associated device was released based on the manufacturer's acceptance criteria.The root cause cannot be determined conclusively.(b)(4).

Event Description

A risk manager reported that following uneventful, bilateral lasik surgery, the patient presented with mild corneal edema and eye dryness in both eyes.Additionally, residual refractive error was noted, which was attributed to the patient's medical diagnoses and healing process.Approximately three months later, the patient was seen and a review of the chart revealed that the right eye had been treated with the refraction of the left eye, and vice versa.This was due to the operator entering the data incorrectly into the laser system.This explained why the patient had residual refractive error.The patient was informed about this error and agreed to have a lasik enhancement.The refractive error resolved with the treatment.Additional information was requested; however, the reporter was unable to provide it.There are two medical device reports associated with this event.This report is for the right eye.

Manufacturer Narrative

Evaluation summary: the system history shows that the laser was verified successfully prior and after the day of treatment.No technical root cause was identified as the product was found to be within specifications.The root cause was the user programming and treating the left eye treatment for right eye, and vice versa.(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
• Manufacturer (Section G): WAVELIGHT GMBH; am wolfsmantel 5; erlangen 91058 ; GM 91058
• Manufacturer Contact: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5647078
• MDR Text Key: 45010910
• Report Number: 3003288808-2016-00827
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Risk Manager
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/15/2016,07/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2016
• 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
• Other Device ID Number: 00380659907135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/31/2016
• Device Age: 3 MO
• Event Location: Other
• Date Report to Manufacturer: 04/15/2016
• Date Manufacturer Received: 07/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR