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 Eye Injury (1845)

Event Date 02/08/2017

Event Type  Injury  

Manufacturer Narrative

The manufacturer reviewed the on-site service documentation which confirmed that the device was working within specification.The investigation has not identified any abnormality or product deficiency related to the incident.The manufacturer reviewed the document labelling for visumax laser keratome.The user manual (ifu 000000-1345-518-ga-sm-fr-290811, page 7 and 8) describes ectasia as a contraindication and side effect that can be associated with the visumax laser procedure.The user manual also advises the hcp to perform a clinical evaluation to identify any additional side effects from the relevant technical literature and medical associations.

Event Description

The health care professional (hcp) reported a case of suspected corneal ectasia for a patient post visumax laser keratome treatment.The hcp also reported that the separation of the lenticle was difficult during treatment.After one year and three months post treatment the patient's uncorrected visual acuity is 4/10 and corrected visual acuity is 7/10, -1.00(-1.50) 40°.All pertinent information available to carl zeiss meditec has been submitted.

• 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: 6397754
• MDR Text Key: 69734556
• Report Number: 9615030-2017-00004
• 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: Inspection
• Type of Report: Initial
• Report Date: 03/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2017
• 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
• Date Manufacturer Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2012
• 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): Disability
• Patient Age: 36 YR