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 04/21/2022

Event Type  malfunction  

Event Description

Customer reported the device is not correctly measuring the axial length (al) anymore.One of the clinicians had measured several patients that had iol data from 2016, and found the measurements taken in 2022 were all 0.7mm out.The iolmaster 700 passes its 5 green calibration checks at startup.The clinic reported this case to the mhra.The wrong al measurement has been used for surgery.Customer has identified a number of patients who have presented with refractive surprises, 13 patients in total to date have had surgery performed using incorrect al data.A deviation of 0.7mm in axial length measurement value corresponds to a deviation of approx.+2 diopter in the surgical outcome (al +0,3mm = -1d).Further patient data is requested but not yet available.Information about any lens re-implantation is not available so far.

Manufacturer Narrative

The reason for the observed deviation of the axial length is an incorrect opdmzi value.However; the fact that the opdmzi was entered incorrectly is not due to production or factory repair.The error was most likely caused by the local service technician who entered incorrect configuration data into the measurement head when replacing the measurement head during repair.It is likely that an invalid service procedure had been performed on the device.

Manufacturer Narrative

Description of changes: field g3: added "date received by manufacturer".Field g6: updated to "follow-up" ,"1".Field h2 : selected "device.Evaluation".Field h3: updated device evaluated by manufacturer? to "yes".Selected evaluation summary attached.Field h6: updated type of investigation to "10".Updated investigation findings to "115".Updated investigation conclusions to "51".Field h10: added description of changes.

• 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: manjaya hegde ; 5300 central parkway; dublin, CA 94568 ; 9255574100
• MDR Report Key: 14403259
• MDR Text Key: 300158238
• Report Number: 9615030-2022-00004
• Device Sequence Number: 1
• Product Code: HJO
• UDI-Device Identifier: 04049471092080
• UDI-Public: (01)04049471092080(11)160901
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K143275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 06/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2016
• 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