MAUDE Adverse Event Report: WAVELIGHT GMBH ALLEGRETTO WAVE EYE-Q EXCIMER LASER; OPHTHALMIC EXCIMER LASER SYSTEM

Catalog Number 8065990601

Device Problems Device Displays Incorrect Message (2591); Reset Problem (3019)

Patient Problem Keratitis (1944)

Event Date 09/10/2015

Event Type  malfunction  

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.No udi required due to this device was out of production prior to the september 24, 2014 udi regulation date.(b)(4).

Event Description

A technician reported a patient moved eyes while laser was firing on patient's right eye during photo refractive keratectomy (prk).Eye tracker was lost.A system message appeared and was reset.The system could not track the eye after this happened and treatment could not be completed.Treatment was rescheduled to a later day.

Manufacturer Narrative

A review of logfile of the treatment day showed that the system messages had occurred.The messages indicate the position of the pupil was not within tolerance, the treatment was interrupted because the laser pedal was released by the user and the laser system went to standby mode.The logfile shows the treatment was interrupted two times because the laser pedal was released by the user.The treatment was only completed to 25%.All other treatments before and after this treatment at this day were completed to 100% without any problem.The root cause for the message ¿the position of the pupil was not within tolerance¿ is that the patient´s eye was moving during treatment.The root cause for the incomplete treatment is that the laser pedal was released by the user.(b)(4).

• Brand Name: ALLEGRETTO WAVE EYE-Q 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 ; am wolfsmantel 5; erlangen 91058 ; GM 91058 ; 8175686660
• MDR Report Key: 5127495
• MDR Text Key: 27845173
• Report Number: 3003288808-2015-06518
• 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
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 12/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065990601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2010
• 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: 32 YR