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

Model Number N/A

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

Patient Problems Dry Eye(s) (1814); Vitreous Floaters (1866); Halo (2227); Anxiety (2328); Discomfort (2330); Eye Pain (4467)

Event Date 10/14/2020

Event Type  Injury  

Manufacturer Narrative

The manufacturer evaluated the available information and could not find a complaint, which would match with this event.No further data, (e.G.Any contact data of patient, health care professional location, or user facility) could be obtained.Nor any other device related data is available.The patient did not allege a device problem.The user manual for visumax identifies some of the side effects described by the patients as known contraindication and side effects that can be associated with the visumax laser procedure.The user manual also advises the health care professional to perform a clinical evaluation to identify any additional side effects from the relevant technical literature and medical associations."side-effects and complications are not limited to this list.Please consult medical literature and associations for additional side effects".

Event Description

Carl zeiss meditec, inc.Received from the fda voluntary event report mw5096471, which was submitted by a patient.The patient reported experiencing side effects post lasik surgery in 2017.The side effects described by the patient are dry eye, floaters, halos, starburst, glare and poor night vision in both eyes.The patient further reported that these symptoms have caused persistent anxiety, pain and discomfort, adversely affecting everyday function, ability to work, quality of life mental health and general well being.The devices listed for treatment were the visumax femtosecond laser (manufactured by carl zeiss meditec) and the nidek ec-500 excimer laser.

• 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 7745 ; GM 7745
• Manufacturer (Section G): CARL ZEISS MEDITEC AG (JENA); carl zeiss promenade 10; jena, thueringia 7745 ; GM 7745
• Manufacturer Contact: vernon brown ; 5160 hacienda drive; dublin, CA 94568 ; 9255574689
• MDR Report Key: 10825585
• MDR Text Key: 215944599
• Report Number: 9615030-2020-00014
• Device Sequence Number: 1
• Product Code: OTL
• Combination Product (y/n): N
• PMA/PMN Number: P150040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2020
• 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