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 10/03/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturing record reviewed.No abnormalities that could have contributed to this event were found.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 system displayed a secondary energy too high error during treatment and the treatment was stopped at six percent of the treatment.It was noted that the system sat idle for an extended period of time before the surgery day.A gas exchange and energy check was completed which corrected the error.Additional information received states the patient was prescribed topical steroid, topical antibiotics, and topical tear drops.

Manufacturer Narrative

During technical onsite visit the field service engineer (fse) found the system was not used for long period of time before the start of the surgery day.The fse walked the customer through check the arf and nitrogen.A new gas change and energy check were performed.The energy issue was fixed.The system meets specification per service installation record.Additionally, the fse coordinated with a company representative to advise the customer how to restart and correctly complete the procedure that was underway.The root cause is the system was not used for a long period of time before the start of the surgery day, so the system needed several gas change and energy checks.There is no indication the product malfunctioned.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: 9244159
• MDR Text Key: 190608460
• Report Number: 3003288808-2019-01061
• 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: other
• Type of Report: Initial,Followup
• Report Date: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• 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: 11/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 23 YR