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

Catalog Number 8065990713

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Visual Impairment (2138)

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 physician reported a patient complained of unsatisfactory vision post lasik.Corneal flap folds were noted.The patient was referred to another physician.This physician reported that the patient had keratoconus prior to the surgery that was performed and that lasik was contraindicated for this patient.This physician performed a topography guided treatment and cross linking to stiffen the corneal structure.The patient did not have a significant improvement in vision following these additional treatments.There are two related reports for this patient.This report addresses the patient's left eye and another manufacturer report will be filed for the fellow eye.

Manufacturer Narrative

The device history records (dhr) for the device was reviewed.No abnormalities that could have contributed to this event were found.The associated device was released based on company's acceptance criteria.The system history showed no abnormalities that could have contributed to this event.The review showed that the laser was successfully verified prior to and after the date of event/treatment.Logfile review of the initial treatment showed that only eight minutes after initialization of the device, the first energy check was performed.The system passed successfully the eyetracker test with a minimal offset.The user got an error message which leads to incorrect measurement.The customer retried the fluence test and got the same error message.However, target measured depth was achieved.Right after the system tests, the user started the first treatment without performing the required energy check.In summary, only three energy tests were performed during the whole treatment day.The conclusion is that the device was used not according to instructions.There is no indication that the device caused or contributed to the reported incident/adverse event.It is evident that the user did not operate the device according to the user manual.Thus, the energy applied cannot be determined to be valid.The root cause is determined as use error.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

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

Event Description

New information was received.Post-operative topography shows a coma-like appearance with bad visual acuity for the patient, the patient was sent to another doctor who performed a bilateral topography treatment on top of the first treatment.Patient's left eye seems ok after this second procedure.

Manufacturer Narrative

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

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

New information was received.In 2012, the patient was very anxious and wanted to be relaxed.The patient wanted to join the army to be a diver.The army told him that refractive operating technique was not suitable.The patient had glasses and tried contact lenses.He did not like touching his eyes and did not want to try contact lenses again.In the army.The patient is cooking and is cooking underwater.The patient underwent bilateral femtosecond laser treatment under hypnotic suggestions because of palpebral spasm plus.Excimer treatment was performed without issues.Three days post-operatively.The patient's palpebral spam was tonicity plus.The patient's vision was blurred and pain was ended.Five days post-operatively, a lens was noted to be on the eye.Approximately two months post-operatively, the patient experienced a decrease in visual acuity where as vision had previously been improving.A second surgeon ruled out diagnosis of eyelid pressure, keratoconus, and the need to place intra-corneal rings.This doctor suggested cross linking to reform and stiffen the bulging part of the cornea.An operation was performed.Approximately five months post-operatively, near vision is ok but distance vision is blurry.The patient had a pair of glass made a month ago but does not see well with them.The patient will be going to sea and wishes to have something done before this departure.Ten months post-operatively, the patient is still not wearing glasses as they do not improve anything.An infiltrate was noted.The patient also is experiencing exophoria in the distance.Over a year post-operatively, topography guided laser touch up photo refractive keratectomy (prk) procedure was performed with cross linking.The patient presented with high degree of aberration rate which does not allow the patient to obtain a satisfactory visual quality.Corneal topographies showed notable decentering of the laser treatment.The shift was superotemporal.Therefore, rigid lenses were recommended.A few micro folds were noted in the upper part of the hood.A few months later, improvement was noted and that it is necessary to wait for healing to be complete.

Manufacturer Narrative

The manufacturer internal reference number is: 2018-79329.

Event Description

Was received.The patient was very anxious prior to the operation.Micro pleats were noted to be greater in the left eye three days post lasik.A contact lens was noted to be placed on the eye and visual acuity was better two - three weeks later.The next month the patient experienced a significant decrease in visual acuity for 15 days.Binocular vision was impaired.Topography showed corneal deformation.The patient indicated that since the operation does not seem to be seeing well.Approximately three months post-operative, the patient underwent topography guided ablation.For the epithelial section, photo refractive keratectomy and crosslinking were performed.The patient complained of weak vision, dryness, and poor healing in the left eye.Contact lens does not seem to improve vision.The patient dreamed of being a baker or in catering on a submarine in the army.Visual issues have cause professional impact as the patient is classified as permanently unfit because of wearing lenses.If he was wearing glasses then he could of been taken.Currently, the patient works on a boat in guyana in the army.A change of assignment and return to catering resulted.The patient is not able to be a baker at the moment because lentils are incompatible with flour.This has caused the patient loss of annuities and retirement.The patient is unable to swim.Work was missed several times.The patient is able to drive with lenses.The patient endured suffering.The patient has depression, visual fatigue and difficulty seeing properly.The cornea will not move anymore and the patient may no longer tolerate the lens.

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: 8069531
• MDR Text Key: 127121605
• Report Number: 3003288808-2018-01824
• 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: foreign,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065990713
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR