MAUDE Adverse Event Report: WAVELIGHT GMBH WAVELIGHT EX500 EXCIMER LASER; OPHTHALMIC EXCIMER LASER SYSTEM

Catalog Number 8065990794

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

Patient Problem Visual Impairment (2138)

Event Date 06/30/2023

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

Event Description

A non-health care professional reported that the surgeon had intended to perform laser-assisted in situ keratomileusis instead of the previously agreed-upon photorefractive keratectomy, however, the patient also experienced panic attacks, post-traumatic stress disorder, psychological damage, frequent emotional breakdowns, and thoughts of suicide, along with this irregular asymmetric vertical astigmatism and vision issues where contrast sensitivity was lost, especially in low light or at night, large blinding starbursts surrounding all light sources, glare, blurred vision was less than two lines and under correction of post operative spherical equivalent was more than one diopter in the right eye of a patient during lasik surgery.The patient was recommended for re-treatment.There are multiple related reports for this event.This report addresses patient bw¿s right eye and other manufacturer reports will be filed.

• Brand Name: WAVELIGHT EX500 EXCIMER LASER
• Type of Device: OPHTHALMIC EXCIMER LASER SYSTEM
• 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: 18968052
• MDR Text Key: 338482566
• Report Number: 3003288808-2024-00082
• Device Sequence Number: 1
• Product Code: LZS
• UDI-Device Identifier: 00380659907944
• UDI-Public: 00380659907944
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065990794
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 31 YR
• Patient Sex: Male