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

Model Number 8065990601

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Visual Disturbances (2140); No Code Available (3191)

Event Type  Injury  

Event Description

A pt reports that ¿halo effect¿, post lasik surgery performed over a year ago, which makes it difficult to drive at night. Pt stated that he was reassured that this effect would go away with time, but was still experiencing it. Pt was informed by his doctor that he has large pupils, a condition which the reporter feels should have been taken into consideration by the doctor before surgery. Despite multiple attempts, to seek add¿l detail, no response was gained from the reporter. This report will reference the pt¿s right eye.

Manufacturer Narrative

Investigation including root cause analysis is in progress. A supplemental report will be filed as necessary in accordance with 21 cfr 803. 56 when add¿l reported info becomes available. (b)(4).

• Brand Name: ALLEGRETTO WAVE EYE-Q`
• Type of Device: OPHTHALMIC EXCIMER LASER SYSTEM
• Manufacturer (Section D): WAVELIGHT GMBH; am wolfsmantel 5; erlangen 9105 8; GM 91058
• Manufacturer (Section G): WAVELIGHT GMBH; am wolfsmantel 5; erlangen 9105 8; GM 91058
• Manufacturer Contact: paul nitschmann ; 6201 south freeway, r3-16; fort worth, TX 76134 ; 8176152440
• MDR Report Key: 2785713
• MDR Text Key: 3034451
• Report Number: 3003288808-2012-00435
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: P030008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer

Reporter Occupation

• Type of Report: Initial
• Report Date: 09/11/2012

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 10/11/2012
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: 8065990601
• Device Catalogue Number: 8065990601
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No
• Date Manufacturer Received: 09/11/2012
• Was Device Evaluated By Manufacturer?: No
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient TREATMENT DATA

Date Received: 10/11/2012 Patient Sequence Number: 1