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

Catalog Number 000000-1932-169

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Visual Impairment (2138)

Event Date 01/31/2023

Event Type  Injury  

Event Description

Customer noticed that after iolmaster software updates, they made a mistake in interpreting the report calculation because the format of the iolmaster report became different compared to previous software version report.The old report format showed se (spherical equivalent) but not sph (sphere) while the new one shows sph.The customer, by mistake, considered sph to be se when looking at the new report.As the previous report calculated se, the technician had to manually do math to get sph power.Since the new report mentions sph, no calculation is necessary, but the technician still did the calculation, resulting in a refractive surprise.

Manufacturer Narrative

There is no indication of any malfunction of the zeiss device that could have contributed to the mix up of sph and se on the printout.The customer site confirmed that there was no malfunction of the iolmaster 700, it performed as intended.The problem occurred when the operator misread the report generated after the software upgrade - values reported in sph which were reported in se before the upgrade.Device history has been evaluated and no device malfunction was reported.According to the provided information, the device passes the calibration check which demonstrate the device is measuring within specifications.Reviewed labeling material to ensure the ifu contains the warning that the refractive power of the iol calculation for toric lenses will be issued in spherical equivalent according to the standard.According to the available information the root cause is a use error, which is neither due to ergonomic features, nor due to any inadequacy in the information supplied by the manufacturer.H3: device not evaluated other code, preferred term would be "error confirmed not to be device related.".

• 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: 16524595
• MDR Text Key: 311092964
• Report Number: 9615030-2023-00003
• Device Sequence Number: 1
• Product Code: HJO
• UDI-Device Identifier: 04049471092080
• UDI-Public: (01)04049471092080(11)200801
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K170171
• 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: 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 000000-1932-169
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2020
• 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
• Patient Age: 69 YR
• Patient Sex: Male