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  

Event Description

Health care professional (hcp) reported a partial cut on the patient's left eye infero-nasally during a smile refractive treatment using the visumax laser keratome.The hcp further reported difficulty in extracting lenticule.He was able to extract only two third of the lenticule and part of the lenticule remained in the patient's eye infero-nasally.The hcp decided to performed a second surgery to remove the remaining lenticule, but it was not successful.According to the hcp, the lenticule was too adherent and therefore was impossible to extract.No adverse consequences to the patient are known.

Manufacturer Narrative

Further updates based on mfr evaluation: date of report: corrected from "8/23/2017" to "7/27/2017".Date rec¿d by mfr: updated from "7/27/2017" to "9/13/2017" for follow up.Type of report: updated from "initial" to "follow-up #: 1".If follow-up, what type?: entered "correction" and "device evaluation".Device evaluated by mfr: updated from "no: device evaluation anticipated, but not yet begun" to "yes".Selected "evaluation summary attached" additional mfr narrative: added description of further updates.

• 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 07745 ; GM 07745
• 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: 6815875
• MDR Text Key: 83458874
• Report Number: 9615030-2017-00017
• Device Sequence Number: 1
• Product Code: OTL
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2011
• 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: 26 YR