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 Visual Impairment (2138)

Event Date 04/21/2018

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.Manufacturing record reviewed.No abnormalities that could have contributed to this event were found.The manufacturer internal reference number is: (b)(4).

Event Description

A technician reported treatment on a patient's eye was completed and then repeated to correct target during a lasik procedure.Upon follow up, after surgeon entered treatment the patient's eye was treated.After the treatment was finished the surgeon realized the incorrect treatment had been performed so at that moment the technician programmed another treatment and was executed to correct.Upon additional follow up, patient original was suppose to have underwent lasik over 6 months again on the left eye but procedure was aborted due to incomplete flap.Patient had returned for photo refractive keratectomy (prk) approximately two months later.Patient complained about near vision and desired monovision treatment.Approximately four months later, the patient returned for a prk enhancement.Surgeon treated with minus sphere power instead of plus sphere power.Surgeon immediately reprogrammed and treated with plus sphere power to address the error.

Manufacturer Narrative

Logfile review shows all laser system functions were within specifications for the respective treatment.The reported treatment could be identified in the logfile.Logfile review confirmed the patient´s left eye was treated with the refraction -1.00 sphere then retreated immediately with refraction 1.25 sphere to correct the error.The root cause is a user error.A root cause of the technical side could be exclude.The user has not entered the treatment plan as a monovision treatment for the patient.(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: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7634115
• MDR Text Key: 112188156
• Report Number: 3003288808-2018-01172
• 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: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/12/2018,09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065990794
• Other Device ID Number: 00380659907944
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/25/2018
• Device Age: 3 YR
• Event Location: Other
• Date Report to Manufacturer: 06/12/2018
• Date Manufacturer Received: 08/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2015
• 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): Other; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 64