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

Catalog Number 8065990739

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 06/26/2020

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.(b)(4).

Event Description

A health professional reported a secondary energy message during refractive treatment.The procedure was completed successfully.Additional information received; the patient did not experience any issues as a result of this event.There are two related reports for this event.This represents patient (b)(6) and an additional report will be filed.

Manufacturer Narrative

A review of the device history record traceable to the reported serial number indicates that the product was processed and released according to the product¿s acceptance criteria.Logfile review shows multiple error messages can be found in logfiles.The messages might occur if a gas change is needed and during the evacuation of the lines if the pressure does not fall below a set limit.A gas change was performed.During technical onsite visit the field service engineer (fse) replaced a sensor, beam splitter and performed system verification as per sir (service installation record).Root cause could not be determined conclusively.The manufacturer internal reference number is: (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
• MDR Report Key: 10286932
• MDR Text Key: 199880172
• Report Number: 3003288808-2020-00424
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065990739
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 31 YR