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

Catalog Number 8065990601

Device Problem Energy Spectrum Incorrect (1210)

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

Event Date 05/08/2015

Event Type  malfunction  

Event Description

A technician reported that at the beginning of lasik treatment in the left eye, the energy of the laser was too low, and the treatment was interrupted at 25% of completion.The system was restarted and an energy check and fluence test was conducted, which fixed the issue.Then, the patient was brought back to complete the remaining 75% of the treatment.The treatment was completed with no further issues.At the one day postoperative visit, the patient presented with good near vision, as planned.The patient did not report any symptoms or concerns.No further information is expected.

Manufacturer Narrative

Evaluation summary: 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 manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Evaluation summary: no sample is expected for evaluation.The device history records (dhr) for the device was reviewed.The associated device was released based on the manufacturer's acceptance criteria.Customer reported system displayed a secondary energy too low at the beginning of a case.A review of the technical service onsite showed no abnormalities that could have contributed to this event: laser was successfully verified prior and after the day of the event.The customer decided to complete the surgery after a successful restart of the system, performing an energy check and fluence test.The root cause could not be identified by the investigation.After a restart, the device worked as intended.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
• Manufacturer (Section G): WAVELIGHT GMBH; am wolfsmantel 5; erlangen 91058 ; GM 91058
• Manufacturer Contact: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 4816003
• MDR Text Key: 15128669
• Report Number: 3003288808-2015-05581
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065990601
• Other Device ID Number: V4-1.02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 46 YR