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

Catalog Number 8065990601

Device Problem Unstable (1667)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 06/22/2017

Event Type  Injury  

Manufacturer Narrative

The device history records (dhr) for the device were reviewed.The associated device was released based on acceptance criteria.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 (b)(6) 2014 udi regulation date.The manufacturer internal reference number is: (b)(4).

Event Description

A surgeon reported unstable laser energy before surgery.After multiple energy tests, treatment was performed on two patients who were noted to have "excessive correction" post treatment.Additional information requested.There are two related reports for this patient.This report addresses the patient two, right eye, and another manufacturer report will be filed for the fellow eye.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received states the patient's symptoms have resolved.

Manufacturer Narrative

Based on information received prior to the submission of supplemental report (smdr 1), this event does not meet criteria for reporting as a serious injury.(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: nadia bailey ; am wolfsmantel 5; erlangen 91058 ; GM 91058 ; 8176152330
• MDR Report Key: 6809703
• MDR Text Key: 83215471
• Report Number: 3003288808-2017-01903
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: P020050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065990601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2011
• 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: 20 YR