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

Event Description

A doctor reported a low myope resulted in an overcorrection one month post operatively.

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.A review of the technical service onsite history showed no abnormalities that could have contributed to this event: laser was successfully verified prior to the day of the treatment.Review of the logfile for the day of treatment showed during the start-up, the system passed all initialization steps without any relevant deviation.The user performed the gas change, skipped the scanner test and performed the necessary energy check, eyetracker and fluence test without any issue.The logfile showed several successfully performed treatments.The user performed an energy check and treated two patients before this corresponding patient.It is recommended, that an energy test is performed before each patient.The measured energy was stable.The corresponding treatment was performed without interruption.No technical root cause was detectable.Clinical application specialist (cas) review concluded as follows: it was reported that after topography-guided treatment with the excimer laser, patients are coming out with overcorrections between +0.50 diopters to +1.00 diopters.The cas reported that the doctor did not follow the final treatment recommendations all the time.The technical evaluation did not show any issues.There are only incomplete treatment reports and no pre-operative and post-operative data added, we cannot say, what might have led to this result.The report showed that the post-operative refraction was done only two to three weeks after treatment.These measurements are not reliable.Therefore, we would need a subjective post-operative refraction done after an appropriate healing time.Recommendation is to review the treatment procedure steps with the doctor.No technical root cause was identified as the product was found to be within specifications.The root cause could not be determined conclusively.Most probable root cause is user handling, as doctor did not follow the final treatment recommendations at all times.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

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: 10610726
• MDR Text Key: 209333709
• Report Number: 3003288808-2020-00589
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• 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: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR