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

Catalog Number 8065990601

Device Problem Power Conditioning Problem (1474)

Patient Problem Visual Impairment (2138)

Event Date 07/07/2017

Event Type  Injury  

Manufacturer Narrative

The device history records (dhr) for the device were reviewed.No abnormalities that could have contributed to this event were found.The associated device was released based on company 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 as this device was out of production prior to the september 24, 2014 udi regulation date.(b)(4).

Event Description

A health professional reported a patient with unstable laser energy prior to lasik treatments.The site reports a patient with an under correction of the left eye following treatment.Additional information has been requested.There are two related reports for this patient.This report addresses the patient's left eye, and another manufacturer report will be filed for the fellow eye.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received; the patient is doing well postoperatively and 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 as an undercorrection.(b)(4).

Event Description

The patient is reported as seeing 100 percent and no additional correction or treatment was required.

• 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: 6803881
• MDR Text Key: 83021460
• Report Number: 3003288808-2017-01898
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2017
• 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: 25 YR