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

Catalog Number 8065000123

Device Problems Failure to Align (2522); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Eye / Vision Problem (4471)

Event Date 04/28/2023

Event Type  Injury  

Event Description

A facility representative reported a patient with a partially created flap in the left eye during the flap creation procedure.A bandage contact lens was subsequently placed, and the patient experienced diplopia post-surgery.

Manufacturer Narrative

H.3., h.6.: 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 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 surgery date.Latest preventive maintenance performed and concluded device met specifications as per service installation record.Not enough information was provided to properly complete an investigation.The root cause could not be identified by the investigation.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: 17975666
• MDR Text Key: 326149848
• Report Number: 3003288808-2023-00278
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065000123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 28 YR
• Patient Sex: Male