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

Catalog Number 8065990713

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 08/16/2017

Event Type  Injury  

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 that the laser was verified successfully prior to the date of event.Based on the provided data, the medical record of this patient shows for the right eye a refraction of +3.00d -3.25d x 179°.The treatment was programmed with positive sign instead of negative sign for the cylinder correction as +3.00d +3.25d x 179°.Clinical review states that the outcome shows an expected induced spherical error and a doubling of the power of astigmatism (as it was treated in the wrong direction).To the current knowledge and further consultation with cas this case can be determined as a serious deterioration in state of health caused by a user error (algebraic sign mix-up "+" instead of "-").Astigmatism of the patient doubled and sorely impairs the patients eyesight.Thus this case is considered as a reportable user error which requires reporting to local authority.The data entered into the program has to be checked and confirmed manually.The device is working as intended.The root cause can be determined as human error.There is no indication a device malfunction caused or contributed to the reported event.The manufacturer internal reference number is: (b)(4).

Event Description

A doctor reported that a patient's astigmatism values were entered incorrectly during a planned lasik treatment.Planned laser treatment results were not achieved.Patient's post-operative refractive values were not correct and a new laser operation was performed.The patient was satisfied with the result.Upon follow up, positive value s were entered when normally negative values should have been entered.Planned result was plano.However, an unexpected result was encountered.The patient had an abnormal refraction.Corrective second treatment was performed.As a result, the patient was extremely happy and has no complaints.

• 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: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 6851811
• MDR Text Key: 85353264
• Report Number: 3003288808-2017-01998
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P020050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065990713
• Other Device ID Number: 00380659907135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2016
• 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
• Patient Age: 29 YR