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

Model Number 8065990631

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

Patient Problems Dry Eye(s) (1814); Visual Disturbances (2140); No Code Available (3191)

Event Type  Injury  

Event Description

Surgeon reported that a pt was not satisfied with surgery results and is complaining that they see badly in the dark with opened pupil (8.7-8.8 mm).Entries in medical record indicate pt refused to use cholinergic eye drops.Surgeon also reporting pt has also complained about dry eye, however pt was recommended to use eye drops but refused any treatment.It was indicated that the surgeon detected anisometropia during the pt's last visit, however the pt refused an additional correction offered by the clinic specialists.The surgeon also reported pt is now having suicidal thoughts.This report references the left eye.The right eye, of the same pt, will be reported separately.Additional information has been requested.

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).

• 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: cynthia kay ; 6201 south freeway, r3-48; fort worth, TX 76134 ; 8176152605
• MDR Report Key: 3370307
• MDR Text Key: 3715974
• Report Number: 3003288808-2013-00517
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: P030008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/15/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2013
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8065990631
• Device Catalogue Number: 8065990631
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2013
• 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 Sequence Number: 1
• Patient Outcome(s): Other