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

Catalog Number 8065990631

Device Problem Output above Specifications (1432)

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

Event Date 02/02/2016

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.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 customer reported the excimer laser had increasing high voltage value very fast, requiring two gas exchanges during the whole refractive procedure.No patient harm was reported.

Manufacturer Narrative

No abnormalities that could have contributed to this event were found during the device history records review and the product was released according to company acceptance criteria.The equipment did not display any error message.The procedure was completed with the same equipment and accessory, with no delay.A root cause has not been identified.Possible root cause worn laser optics.(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: 5458370
• MDR Text Key: 39417847
• Report Number: 3003288808-2016-00355
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P020050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065990631
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2004
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other