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

Model Number N/A

Device Problem Off-Label Use (1494)

Patient Problem Unspecified Eye / Vision Problem (4471)

Event Type  Injury  

Manufacturer Narrative

The treatment was done 4 years ago.The exact time is not known.Detailed patient data is not available.The described case was not known to the manufacturer before.A patient contacted the manufacturer carl zeiss meditec (b)(4) (b)(4) to complain about a misuse of visumax device by a doctor.The patient went to a clinic to do the tests to correct the eyesight, and it was found from tests that the eye condition does not allow surgery due to the presence of a protrusion on the surface of the cornea and its degree of degradation.In spite of that, the doctor did the surgery.In the message to the manufacturer, the patient mentioned a corneal protrusion which is a pathology called keratoconus.Keratoconus is a condition with a relatively high incidence in (b)(6) and an absolute contraindication for laser refractive surgery.This contraindication is clearly stated in the visumax user manual and common clinical knowledge.The described worsening of the patient's myopia would support the assumption of a pre-existing keratoconus.It is necessary to treat keratoconus in order to prevent its progression and to preserve visual potential.

Event Description

A patient from (b)(6) contacted the manufacturer carl zeiss meditec (b)(4) (b)(4) to complain about a misuse of visumax device by a doctor.The patient went to the "(b)(6) center and (b)(6)" in (b)(6) where the doctor performed smile procedure on her eyes.The patient reported that her vision was -3 pre surgery.A week after the surgery her vision deteriorated and became -4.After two weeks, the cornea became irregular.The patient reported that she found out that her eye condition does not allow smile procedure due to the presence of a protrusion on the surface of the cornea and its degree of degradation.Subsequently, a doctor performed an additional procedure to fix the patient's cornea, which led to further deterioration of her condition.According to the patient, her vision decreased 3 times, reaching -7 in the right eye and -9 in the left eye.

• Brand Name: VISUMAX
• 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: viet nguyen ; 5300 central pkwy; dublin, CA 94568 ; 9255574689
• MDR Report Key: 11898121
• MDR Text Key: 255451743
• Report Number: 9615030-2021-00009
• Device Sequence Number: 1
• Product Code: OTL
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: P150040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• 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: 000000-1345-518
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/30/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/14/2015
• 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