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

Model Number 8065990601

Device Problems Energy Output To Patient Tissue Incorrect (1209); Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 09/04/2014

Event Type  Injury  

Event Description

A doctor reported that during a programmed hyperopia procedure with a laser system, he could only fire a few shots and then the treatment stopped.There was no system message displayed.A one (1) second treatment was performed.As the treatment was too short, the optician programmed the laser system again with a different pupil size of 4.6 instead of 4.5.A system message was displayed and it was accepted.When importing the treatment data, it stopped at 75% of the data transfer.The retreatment could not be performed and the surgery was postponed to the following week (date unknown).Additional information has been requested, but not received to date.

Manufacturer Narrative

A service visit was performed.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.Additional information has been requested but not received to date.(b)(4).

• Brand Name: ALLEGRETTO WAVE EYE-Q
• 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, r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 4173971
• MDR Text Key: 5087719
• Report Number: 3003288808-2014-01469
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• PMA/PMN Number: P030008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Type of Report: Initial
• Report Date: 09/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8065990601
• Device Catalogue Number: 8065990601
• Other Device ID Number: 4-1.02
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2010
• 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