MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG (JENA) IOLMASTER 700; BIOMICROSCOPE, SLIT-LAMP, AC-POWERED

Model Number 700

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 10/12/2020

Event Type  Injury  

Event Description

A health care professional (hcp) reported that there was an incorrect axial length (al) measurement due to a dirty optic.Therefore, an incorrect iol was selected and implanted.There is no information about any negative impact to the patient, user, or third party due to the reported case.

Manufacturer Narrative

Patient data and log files for investigation were not provided.The customer did not ask for zeiss service because the measurement error was caused by a dirty optic in the iolmaster.There is no problem with the lens itself, and no problem with the iolmaster itself.In the meantime, the optic has been cleaned and the actual measurements are okay.The customer was informed about the root cause of the measurement error.The user manual contains instructions about proper lens cleaning and to cross-check the measurements for plausibility and correct position of measurement marks.Corrected data: g6: follow up; 1; h3: changed from no, to not needed due to user error.H6: investigation findings changed from 3233, results pending completion of investigation, to 646, dust or dirt problem identified; investigation conclusions changed from 11, conclusion not yet available, to 18; failure to follow instructions.

• Brand Name: IOLMASTER 700
• Type of Device: BIOMICROSCOPE, SLIT-LAMP, AC-POWERED
• 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: viet nguyen ; 5160 hacienda drive; dublin, CA 94568 ; 9255574151
• MDR Report Key: 10980571
• MDR Text Key: 220637551
• Report Number: 9615030-2020-00020
• Device Sequence Number: 1
• Product Code: HJO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K143275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 700
• Device Catalogue Number: 000000-1932-169
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/25/2015
• 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): Other