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

Catalog Number 8065990941

Device Problems Bent (1059); Difficult to Insert (1316)

Patient Problem No Code Available (3191)

Event Date 07/17/2017

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.(b)(4).

Event Description

A doctor reported he was unable to complete insertion of the presbyopic corneal inlay of the left eye due to tight tissue opening of the cornea.Upon follow up with company clinical application specialist (cas), it was reported the corneal tissue opening was too tight for the inlay to be inserted.The surgeon opted to abort insertion of the inlay, but did perform a photo refractive keratectomy (prk) enhancement for preparation of the inlay insertion at a later date.Cas also indicated the tool used for inlay insertion was bent making it even more difficult to complete the insertion process.

Manufacturer Narrative

The device history records (dhr) for the device was reviewed.No abnormalities that could have contributed to this event were found.The associated device was released based on company acceptance criteria.The system history shows that the laser was verified successfully prior to and after the date of treatment.The root cause could not be identified conclusively.(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
• 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: 6787857
• MDR Text Key: 82478623
• Report Number: 3003288808-2017-01855
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065990941
• Other Device ID Number: 00380659909412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2015
• 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: 53 YR
• Patient Weight: 68