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

Catalog Number 8065990794

Device Problem Overcorrection (3006)

Patient Problem Insufficient Information (4580)

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 couple of doctors reported that the laser is burning hot when treating high myopic patients.These patients are being over corrected by two diopters at times even when taking off 10%.

Manufacturer Narrative

A review of the device history record was traceable to the reported serial number indicating that the product was processed and released according to the product¿s acceptance criteria.During a technical site visit, the field service engineer (fse) stated that event could not be replicated nor confirmed.The fse tested and verified system was functioning and calibrated within company specifications as documented in the service and installation record (sir).Micrometer calibration was verified.System meets specifications.No technical root cause could be identified as the system was operating within specifications.The root cause cannot be identified conclusively.The manufacturer internal reference number is: (b)(4).

• 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
• MDR Report Key: 11091775
• MDR Text Key: 224246135
• Report Number: 3003288808-2020-00832
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• PMA/PMN Number: P020050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065990794
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other