MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG (JENA) VISUMAX LASER KERATOME; FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION

Catalog Number 000000-1345-518

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

Patient Problem No Code Available (3191)

Event Date 06/30/2017

Event Type  Injury  

Manufacturer Narrative

A zeiss field service engineer (fse) inspected the visumax laser keratome on site and confirmed that the device is working within specification.The manufacturer reviewed the on-site service documentation which confirmed that the device was working within specification in the time period of the reported incident.A number of factors not related to the visumax device may have influenced the surgical outcome.The manufacturer reviewed the document labelling for visumax laser keratome.Difficult lenticule extraction is a potential risks that can be associated with the smile refractive procedure.The user manual ((b)(4)) advises the hcp to perform a clinical evaluation to identify any additional risks and side effects from the relevant technical literature and medical associations.

Event Description

Health care professional (hcp) reported difficulty in extracting lenticule during a smile refractive treatment using the visumax laser keratome.The hcp was unable to extract the entire lenticule and a small part of the lenticule remained in the patient's eye.The hcp performed an additional surgery to remove the remaining lenticule.No adverse consequences to the patient are known.

• Brand Name: VISUMAX LASER KERATOME
• Type of Device: FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION
• Manufacturer (Section D): CARL ZEISS MEDITEC AG (JENA); carl zeiss promenade 10; jena, thueringia 11545 46; GM 1154546
• Manufacturer (Section G): CARL ZEISS MEDITEC AG (JENA); carl zeiss promenade 10; jena, thueringia 07745 ; GM 07745
• Manufacturer Contact: william gustafson ; 5160 hacienda drive; dublin, CA 94568 ; 9255574689
• MDR Report Key: 6752016
• MDR Text Key: 81363478
• Report Number: 9615030-2017-00014
• Device Sequence Number: 1
• Product Code: OTL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P150040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 07/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 000000-1345-518
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2016
• 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): Required Intervention