MAUDE Adverse Event Report: WAVELIGHT GMBH WAVELIGHT FS200 FEMTOSECOND LASER; OPHTHALMIC LASER

Catalog Number 8065000123

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Keratitis (1944)

Event Date 01/11/2022

Event Type  Injury  

Event Description

A customer reported diffuse lamellar keratitis in the right eye of a patient, after lasik surgery.There are multiple related reports for this reported event.This report addresses patient initials ga, right eye, and additional manufacturer reports will be filed for the other patients.

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

Manufacturer Narrative

A review of the device history record (dhr) traceable to the reported serial number indicates that the product was processed and released according to the product¿s acceptance criteria.A review of the technical service onsite history showed no abnormalities that could have contributed to this event: laser was successfully verified prior to and after the day of the treatment.Review of the logfiles for the day of treatment shows no relevant errors or any relevant warnings.During start-up of the system the vacuum, the energy and the ablation tests were performed without any issue.The energy was stable during the whole day.The logfile shows two successfully performed treatments.The reported treatment could be identified in the logfile.The treatment was finished successfully without any issue.No relevant deviation between planed and performed energy is detectable for the reported treatment.The user operated surgery within the recommended energy settings.The thickness of the flap was thinner than the recommended flap thickness.No technical root cause could be identified.Root cause for the customer¿s reported event could not be determined conclusively, however occurrences of diffuse lamellar keratitis are a known complication of lasik and other refractive surgeries; it is not likely that a product malfunction could have contributed to the reported event.The manufacturer internal reference number is: (b)(4).

• Brand Name: WAVELIGHT FS200 FEMTOSECOND LASER
• Type of Device: OPHTHALMIC LASER
• 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: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 16067926
• MDR Text Key: 306333154
• Report Number: 3003288808-2022-00352
• Device Sequence Number: 1
• Product Code: OOE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141476
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065000123
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2019
• 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: 35 YR
• Patient Sex: Male