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 Problems Dry Eye(s) (1814); Vitreous Floaters (1866); Headache (1880); Nausea (1970); Blurred Vision (2137); Visual Impairment (2138)

Event Date 07/04/2018

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-doks-sm-kr-211114, p.6-9) describes ectasia as a contraindication and side effect that can be associated with the visumax laser procedure.Moreover the user manual describes headache, dry eye, visual disturbance as side effects that can be associated with the visumax laser procedure.The user manual also advises the healthcare professional to perform a clinical evaluation to identify any additional side effects from the relevant technical literature and medical associations.

Event Description

On 11/29/2018, carl zeiss meditec (czm) received a voluntary report (mw5081613) from the fda submitted by a patient who underwent a relex smile surgery on (b)(6) 2018 with the visumax device and collagen-cross linking (cxl).Cxl is a treatment that is provided by a third party company and it is not in the responsibility of czm.Per the report, the patient's eye sight was not corrected to 1.0 after the surgery - the patient's vision on the left eye was reported to be 0.5 while the right eye was reported to be 0.6.The patient reported seeking other doctors' opinions.They communicated to the patient that this is an irregular astigmatism which cannot be corrected by glasses.The patient reported experiencing numerous side effects such as headaches, nausea, double vision, blurry vision, ghosting, glare, starburst, shadows, dry eye, eye burning, eye pain, floaters and ectasia.Treatment videos and patient information were requested from the eye clinic in (b)(6), but due to local regulations, it has not been provided.The patient's pre-operative conditions are currently unknown and stable post-operative information were not provided for each eye.

• 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: vernon brown ; 5160 hacienda drive; dublin, CA 94568 ; 9255574616
• MDR Report Key: 8192604
• MDR Text Key: 131302578
• Report Number: 9615030-2018-00014
• Device Sequence Number: 1
• Product Code: OTL
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P150040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• 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
• Date Manufacturer Received: 11/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2016
• 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): Other