MAUDE Adverse Event Report: WAVELIGHT GMBH WAVELIGHT FS200 FEMTOSECOND LASER; POWERED LASER SURGICAL INSTRUMENT

Catalog Number 8065990941

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Patient-Device Incompatibility (2682)

Patient Problems Eye Injury (1845); Unspecified Infection (1930); Keratitis (1944); Pain (1994)

Event Date 12/20/2018

Event Type  Injury  

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.The device history records (dhr) for the device was reviewed.The associated device was released based on company acceptance criteria.(b)(4).

Event Description

A facility representative reported the flap was not separated completely.Follow up information received stated the patient was diagnosed with herpes viral keratitis after the surgery.The patient complained the eyes hurt.The cornea is turbid but slowly getting better.There are multiple related reports for this event.This report addresses the eighth eye performed for the surgical day, and another manufacturer report will be filed for the other affected cases.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

Initial information provided also stated the patient is on topical steroids, antibiotics, and hormones.

Manufacturer Narrative

Review of the logfiles for the day of treatment shows no relevant errors that could contribute to the reported event.During start-up of the system the vacuum, the energy and the ablation tests were performed without any relevant errors.The logfile shows treatments finished successfully on that day.The logfile shows the energy is stable during treatment.No relevant deviation between planned and performed energy is detectable for the treatment.The user operated surgery with the recommended settings.Only the vacuum suction time for the treatment was longer than usual.Additionally, the logfile shows that the user performed energy check at system startup and then performed second energy check four and half hours later.No abnormality regarding z-offset setting can be identified.No technical root cause is detectable during logfile review.Clinical application specialist (cas) review stated an excessive amount of liquid between the cornea and the patient interface and a not fully applanated cornea are noticeable.From the clinical perspective that might have led to the incomplete prepared flap.As the customer has multiple cases with poor docking, long suction times and sticky flaps, cas strongly recommended further training and reviewing the docking principles with this customer.No technical root cause was identified as the system was operating within specifications.The possible root cause could be docking technique and/or eye movement during treatment.The manufacturer internal reference number is: (b)(4).

• Brand Name: WAVELIGHT FS200 FEMTOSECOND LASER
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): WAVELIGHT GMBH; am wolfsmantel 5; erlangen 91058 ; GM 91058
• MDR Report Key: 8253543
• MDR Text Key: 133242546
• Report Number: 3003288808-2019-00056
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• PMA/PMN Number: K101006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065990941
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/20/2018
• Initial Date FDA Received: 01/16/2019
• Supplement Dates Manufacturer Received: 02/07/2019; 05/02/2019
• Supplement Dates FDA Received: 02/22/2019; 05/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 28 YR