MAUDE Adverse Event Report: WAVELIGHT GMBH ALLEGRETTO WAVE EYE-Q EXCIMER LASER; OPHTHALMIC EXCIMER LASER SYSTEM

Catalog Number 8065990601RP

Device Problem Improper Device Output (2953)

Patient Problems Visual Impairment (2138); No Known Impact Or Consequence To Patient (2692)

Event Date 02/28/2015

Event Type  Injury  

Event Description

A surgeon reported that following lasik surgery, a total of nine patients were either undercorrected, or had flipped axis of astigmatism.The surgeon did not specify how many patients had each of the outcomes.Additional information has been requested.

Manufacturer Narrative

Evaluation summary: 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).

Manufacturer Narrative

Evaluation summary: according to the logfile review, no treatment was found on (b)(6) 2015.However, the logfile review for the day (b)(4) 2015, showed that all treatments were completed to 100 % and all laser system functions were within specifications.The system history showed that the laser was successfully verified prior to the date of treatment.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 the manufacturer's acceptance criteria.Additional follow up was conducted, in order to confirm the date of the reported event.No new information has been received.Based on the current, information the root cause cannot be determined conclusively.

Event Description

In a follow up, the surgeon provided patient identifiers for one patient that was diagnosed with an overcorrection of cylinder and 'flipped axis." the patient also experienced an unexpected outcome in the fellow eye, as well as glare, halos, and blurred distance vision in both eyes.The surgeon also reported that one of the four trackers on the laser system was noted to be "off-line" during the procedure.There are two medical device reports associated with this event.This report is for the right eye.An additional report is being filed for the left eye under mfg.Report # 3003288808-2015-05384.

Manufacturer Narrative

(b)(4).

• Brand Name: ALLEGRETTO WAVE EYE-Q 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 9105 8; GM 91058
• Manufacturer Contact: janet moran ; 6201 south freeway; mail stop r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 4664572
• MDR Text Key: 5683902
• Report Number: 3003288808-2015-05166
• Device Sequence Number: 1
• Product Code: LZS
• 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
• Source Type: Health Professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065990601RP
• Device Lot Number: ASKU
• Other Device ID Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• 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: 39 YR