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 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 separated but the edge of the flap had to be cut with scissors.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 seventh 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 also stated after ablation, a very thin residual stroma was found in the right eye.Flap thickness was 350 microns and residual stroma was 150 microns.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 all 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.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.According to received information in the postoperative pictures (that were made 3-4 days after the surgery) the flap of the right eye has a thickness of ca.350 mkm in the center and gets thinner to the periphery.Follow up information shows the patient has a postoperative issue with herpes keratitis.It is not sure if this condition was already present preoperatively and how this might have had an influence to the reported event.Clinical application specialist (cas) review stated a poor and decentered docking are noticeable on the right eye.From the clinical perspective that might have led to the decentered and sticky flap, but does not explain the thickness.The treatment report shows the eyes have not been fully applanated and that there was a lot of liquid between the cornea and the patient interface.Usually such poor docking would lead to rather thinner flaps.Therefore, this can not be directly linked to the apparently thick flap.With the current provided data a further investigation can not be done.Knowing that there have been multiple cases with poor docking, long suction times and sticky flaps, it is strongly recommended for further training and reviewing the docking principles with this customer.No technical root cause was identified as the system was operating within specifications.The root cause could not be determined conclusively.The possible root cause for the incomplete flap could be docking technique or eye movement during treatment.The root cause for the thick flap after surgery could not be determined conclusively.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: 8253541
• MDR Text Key: 133242571
• Report Number: 3003288808-2019-00057
• 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