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

Catalog Number 8065990713

Device Problems Inadequate Instructions for Healthcare Professional (1319); Improper or Incorrect Procedure or Method (2017)

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

Event Date 05/19/2017

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.(b)(4).

Event Description

A doctor reported a planning error in cases with axis deviations greater than 15 degrees between topography and cylinder.Untreated eyes were scored according to the topography guided protocol for post treated eyes and cylinders were omitted accordingly in the treatment.Patients impact is unknown.Upon follow up, it was noted that this is a clinical planning error and that the device will not be evaluated.Sales representative informed that it was basically an application error.The doctors stated that the function of the machine was not properly explained.Sales representative added that there was either a misunderstanding or wrong explanation.Deviations from the scope were determined by the healthcare professional.

Manufacturer Narrative

A supplemental medical device report (smdr) # 01 is being filed to correct the date on the prior filed medical device report.Incorrect date of (b)(6) 2018 is being corrected to (b)(6) 2018.(b)(4).

Event Description

There are multiple related reports for this facility.This report addresses patient (b)(6) right eye and other manufacturer reports will be filed.

Manufacturer Narrative

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 company¿s acceptance criteria.The system history shows no abnormalities that could have contributed to this event.The review shows that the laser was successfully verified prior to and after the date of event/treatment.Clinical investigation on site revealed that the cylinder was not included in treatment plan which was the reason for retreatment.The wrong protocol was used for treatment planning.The root cause for the reported planning error was a planning issue of topography guided cases in regards to the treated astigmatism value.The user was following a wrong protocol and therefore the cylinder was not treated.Thus, the planned treatments lead to an undercorrection of the cylinder (cause it wasn't treated) which would require retreatment of some patients.Specific details for all affected patients are currently not available.(b)(4).

Manufacturer Narrative

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

Event Description

Additional information was received.The customer complained about the missing of current handling instruction.The healthcare professional explained only verbal instructions for the laser were given and no documents have been handed out to employees.The customer asked that current work instructions need to be handed out urgently.Clinical applications specialist (cas) reported that the training with the customer did not go well.It was only conducted verbally.The customer requested written instructions for the treatment with the correction protocol information in it.The manufacture has released this information to the cas to hand to the customer.

• 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: 7671289
• MDR Text Key: 113511308
• Report Number: 3003288808-2018-01248
• 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,Followup
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2018
• 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: 09/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 30 YR