MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG (JENA) MEL80 EXCIMER LASER SYSTEM

Model Number 80

Device Problems Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)

Patient Problems Visual Impairment (2138); No Code Available (3191)

Event Date 07/14/2020

Event Type  Injury  

Manufacturer Narrative

The user manual describes the handling of the fluence test as well as the treatment.The device executes all functions as described in the manual and the doctor can follow the progress of the fluence test on the monitor if the test is activated.

Event Description

A doctor in (b)(4) reported that during treatment with the mel80 excimer laser system, a mistake occurred.The treating physician reported the fluence test procedure was performed on a patient's eye.The fluence test is required to be carried out on the mel80 excimer laser system prior to starting the treatment.It is not known whether the patient has lost more than 2 lines of the best corrected visual acuity (bscva).However, an intervention, not part of the treatment plan, is required to prevent permanent impairment.

Manufacturer Narrative

H3: changed from yes to no; changed from device evaluation anticipated, but not yet begun to other.Preferred code is user error; h6: investigation findings changed from 3233 (results pending completion of investigation) to 213 (no device problem found), investigation conclusions changed from 11 (conclusion not yet available) to 18 (failure to follow instructions).

• Brand Name: MEL80 EXCIMER LASER SYSTEM
• Type of Device: EXCIMER LASER SYSTEM
• 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 ; 5574616
• MDR Report Key: 10396813
• MDR Text Key: 202571981
• Report Number: 9615030-2020-00008
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P060004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 80
• Device Catalogue Number: 000000-1429-382
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/22/2016
• 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): Required Intervention